Here at PCG Solutions, we continuously think of ways to enhance Viedoc and simplify clinical research. This means that we’re constantly developing new features and strive to present them in an engaging layout, making the workflow smoother and the user experience more enjoyable.
Apart from working with an EDC system that is easy to use, another key element to all successful clinical trials is information security and data integrity. These areas are integrated in our quality management system and have always been at the heart of the Viedoc platform. Now, to further strengthen the stability, availability and security of Viedoc, we decided to formally standardize our information security. That’s why we are taking steps to become certified by the globally recognized standard ISO/IEC 27001.
ISO/IEC 27001 is developed and published by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) and is a standardized management system for information security (ISMS). For you, this means that your research will be secured in an EDC system that follows a globally recognized framework for best-practice information security management.
As part of the certification process, we recently celebrated a successful migration to Microsoft Azure, which is at the forefront of global cloud-computing development, and also certified in ISO/IEC 27001. Further steps will be taken to complete the process, which is to be finished early next year. Stay tuned…
Viedoc Stories - How Viedoc Makes A Difference
MCRA, a US-based CRO specialized in medical devices, is entering its second year using Viedoc. Our colleague Johannes sat down with them to follow up how things are going, and thankfully, there’s been a few moments where Viedoc has proven itself to be superior to any other system they have ever used.
Short setup time
That time they were really short on time and managed to set up an entire study in 8 hours using Viedoc’s streamlined setup process. “Mind-blowing” says the user.
That time they had a site visit with a study coordinator who was unhappy with how the CRF had been designed, so they re-designed the forms in real time during the meeting using Viedoc Designer. “Jaw-dropping experience” for the coordinator who had been working with clinical trials for 25+ years.
That time the monitor was stressed out because he had a site monitoring visit the next day and had previously never seen Viedoc. Thanks to Viedoc’s fun and easy tutorial videos and eLearning resources, the monitor self-trained in no-time and performed the site visit without any hiccups!
The few occasions support was needed, it was provided quickly and personally so their studies could run smoothly.
UMC, Uppsala Monitoring Centre, is launching a Chinese version of the WHODrug Global medical coding dictionary. On May 16th, Viedoc presented how the new Global Chinese dictionary is implemented in the medical coding application in Viedoc.
On September 1st 2019, UMC will launch a Chinese language version of WHODrug Global, UMC’s standardized drug reference dictionary, as a step to help WHODrug users operate in their native language. The Chinese version, named WHODrug Global Chinese, includes information on drugs approved in China in addition to all drug information already available in WHODrug Global. WHODrug Global Chinese also features all ATC texts of the ATC hierarchy in China and will be continuously updated with new information in Chinese. The use of WHODrug Global Chinese will allow for simpler data submissions to authorities both within and outside of China.
On May 16th, the WHODrug Global User Group Meeting was held in Beijing where Viedoc representatives did a live presentation explaining how the new dictionary works in Viedoc and how efficient medical coding is in general. Thanks to Viedoc’s flexible database structure and since WHODrug Global Chinese is delivered as a separate dictionary file package following the same file structure as the English version, the implementation was straightforward without any need for additional development of the platform.
If you want to know more about how to code medical products and terms in Viedoc, don’t hesitate to contact us here.
5 reasons why ViedocMe should be your BYOD ePRO / eCOA solution
ePRO solutions allow patients to report clinical trial information directly from mobile devices into electronic CRFs. This eliminates both the need for data entry by site staff and potential transcription errors, as data are collected directly from the source and stored in the ePRO system’s or EDC system’s database.
ViedocMe is the ePRO/eCOA solution on the Viedoc platform. Below we have listed five reasons why you should consider ViedocMe for your next ePRO/eCOA-study.
Zero footprint – no loss of data
ViedocMe is a web-based, app-like cloud application. What that means is that the software is on the server – all that is required on the user’s device is a web browser that supports standard HTML. Once the user logs on to ViedocMe the application has the same look and feel as an App installed on the device – but without being installed. There is no software or data stored on the device, and if the user should lose or change devices it doesn’t affect the data collection in the slightest.
The largest single expense in an ePRO/eCOA trial is the cost of purchasing, distributing, repairing, replacing and collecting the devices used. In addition the site and subject need support for these devices, meaning the ePRO/eCOA vendor must supply a helpdesk that is in direct contact with them. Helpdesk must be provided in all languages applicable for the study – even if the investigator might speak English there is no guarantee that the subjects can. Bring Your Own Device – BYOD – totally removes the device expense and the need for any direct contact between the vendor and the site or subject. The subject is using their own device, a device they are already familiar with. The zero footprint solution means there is no data stored on the subject’s device, and no data loss if their device should be lost, stolen or replaced.
Data instantly accessible and the eCRF is the source data
In a traditional ePRO/eCOA solution the data is stored in a separate database hosted by the ePRO/eCOA vendor. That database can either:
be handled separately (i.e. all clinical research staff from the study nurse and investigator to the monitor and data manager get logins to that system as well as the EDC system), or
the data can be transferred to the EDC database via synchronization, usually once a day (e.g. at midnight).
ViedocMe transmits the ePRO/eCOA data directly to the eCRF, with no secondary databases. The eCRF contains the source data – the first and only enduring storage of the data collected (as no data is stored locally on the devices). Hence, the source data are the data stored in the central database.
Source data should be accurate, which means that a procedure should be in place to address the situation when a study subject realizes that he/she has made a mistake and wants to correct the submitted data. ViedocMe offers support for correcting ePRO data in a way that helps finding the optimal balance between data authenticity and data quality, while at the same time preserving data integrity. Such a balance is achieved by not allowing for excessive rethinking of answers by subjects, but instead providing a built-in threshold that serves as a filter for those changes that really lead to an improved accuracy of the data, and by recording all changes in an audit trail that is accessible for both investigators and sponsor users.
ViedocMe is configured and setup as part of the standard Viedoc study design, using the same tools and forms. When you set up a form in Viedoc you select if you want to post it to the subject or if it will be part of the regular CRF. This allows you to set up both the CRF and the subject questionnaires simultaneously, saving time and money. There is no need for additional training or special personnel to setup the ePRO part of your study.
New feature streamlines user training with documented self-certification
To ensure high data quality and patient safety, users are required to be knowledgeable in the systems they work with, and familiar with study-specific information such as what data to collect, and how to handle the medicinal product under investigation. Viedoc’s new self-certification feature gives sponsors full control over which training users need to complete to gain access to the study. And it’s all documented.
According to Good Clinical Practice, the sponsor is responsible for all users being appropriately trained in the required protocols and systems in any given study. The ICH Good Clinical Practice guidelines state that investigators should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial. The investigator should also be thoroughly familiar with the appropriate use of the investigational product: how should the product be handled, stored, dispensed, and administered, and any unused product returned at the end of the study. It is the sponsor’s task to ensure that written instructions are in place describing these procedures, and that the investigators have received and understood this information.
Quality and timeliness of data collection also depends on the users being familiar with the system they work with. Clear instructions on how to add subjects, enter data in the CRFs, raise, answer and approve queries, and export data need to be available for users at any time. All this is necessary for maintaining quality and ensuring compliance with the protocol and the applicable standards and regulatory requirements.
To support this, Viedoc has now launched a self-certification feature enablingsponsors to choose what type of training a user needs to complete before gaining access to the CRFs. The module can be designed from Viedoc’s own eLearning material, film clips, the study protocol and study documents or possibly links to a web page with information to be read – or any combination of these. The documentation and training materials can be set to mandatory reading before the user can launch the study, or set to optional reading that is available for reference at any time during study progress.
“This is a feature that greatly facilitates site training and streamlines the research process as a whole,” says Henrik Blombergsson, co-founder and COO of Viedoc.
When a user has completed the mandatory sections set out by the sponsor, they immediately receive an automatically generated certificate and gain access to the study.
The GCP guidelines also require sponsors to ensure that the information provided is up to date. Investigator Brochures are reviewed at least annually and revised as new information regarding the investigational product, or anything else in the trial, becomes available. Sometimes, relevant information may be so important that it should be communicated to the investigators even before a revision of the Investigational Brochure has been realized. Supplying the sites with such information in a timely manner greatly assists in the successful management of the trial, and at Viedoc we have even thought about that!
“The sponsor has the option to make each user repeat the certification at an interval the sponsor chooses. This ensures that each user is regularly updated and aware of potential updates or changes within the study,” says Henrik, and continues:
“To have users with adequate knowledge about the system and the specific study parameters is crucial to guarantee quality of the study and safety for the participating patients. Viedoc’s documented self-certification helps ensure this.”
Functionality and Usability Reduce Lead Times – the Reason CRO Aptus Clinical Chose Viedoc
Functionality, API integration capabilities and overall usability were the key criteria when Clinical Contract Research Organization Aptus Clinical chose Viedoc as their new EDC system last year.
“Viedoc was our first choice both when looking at the technical specification and more hands-on demonstrations. Now we can be completely self-sufficient in building our studies, which greatly reduces our lead times,” says Paul Blaney, Digital Health Lead at Aptus Clinical.
With a 20-year track record of delivering Phase I-III clinical trials, Paul Blaney knows what it takes to be successful in this area. He and his Aptus Clinical colleagues evaluated six different EDC systems in three phases, where Viedoc scored the highest in each phase.
“Naturally there’s always some growing problems to work out in the beginning but overall Viedoc fulfills all our needs, and we’re looking forward to working together for a long time to come.”
One of the deciding factors was Viedoc’s API integration capabilities.
“It’s vital for us to be able to seamlessly import and export XML and ODM files from our local systems and Viedoc’s functionality is excellent in that regard. Working with several separate systems is always a risk factor but with Viedoc’s API, it’s a non-issue.”
Aptus Clinical has now been up and running with Viedoc for some time, says Paul and summarizes: “The combination of high functionality and user-friendliness is what makes Viedoc stand out”.
About Aptus Clinical
Founded in 2013, Aptus Clinical is a specialist UK-based Clinical Contract Research Organization (CRO) with particular expertise in oncology, rare diseases and advanced, cell and gene therapies. Aptus Clinical is part of iMATCH, a Manchester-based consortium which is one of only three centres in the UK to be awarded funding by Innovate UK to coordinate scale-up of advanced therapies for a range of debilitating conditions.
Trust, service and reliability – Here’s why Oslo University Hospital signed a 10-year EDC deal
For Oslo University Hospital (OUH) it was a matter of trust, service and quality that helped them sign a 10-year deal with Viedoc.
– We’ve been working with Viedoc for four years, and it was an obvious choice to extend our partnership. Auditing and evaluating a new EDC system is an extensive process, especially for us as a public institution. Now we know that we’ll have access to a high-quality EDC system that we’re used to working with for a long time to come, says Cecilie Moe, Manager Data Management Section, OUH.
So far, OUH has performed over 50 studies with more than 1,300 participants in Viedoc. With the newly signed 10-year deal, OUH will continue using Viedoc for a long time to come.
– Viedoc exceeds all our needs when it comes to EDC and ePRO. The decision to use Viedoc was also a question of service and support – Customer service at Viedoc is easy to reach and quickly replies to our questions, feedback and suggestions. The people at Viedoc are just as important as the technical quality and are a major reason why we wanted to sign on for 10 more years.
A lot can happen in 10 years technology-wise, especially when it comes to Electronic Data Capturing, but OUH is confident Viedoc’s position will remain at the forefront of the EDC industry.
– We have firsthand experience of the high-quality development, upgrades and new features that Viedoc continuously implement into their system. and I expect them to further innovate the system for years to come.
Cecilie Moe sees no reason why the OUH – Viedoc partnership wouldn’t continue past the newly signed 10-year deal.
– Now that we’re sure we have an EDC system that works well for us now and over the long run, we can focus all our time and attention on the research.
About Oslo University Hospital
Oslo University Hospital carries out advanced patient treatment, research and trial treatments, gives advice and provides education on international levels. The hospital is Scandinavia’s largest and each year carries out more than 1.2 million patient treatments. Oslo University Hospital is responsible for approximately 50 percent of all medical and healthcare research conducted at Norwegian hospitals and is a significant role player within the education of a large variety of health care personnel.
Time to celebrate yet another milestone – 250 audits
In compliance with current legislation both regulatory authorities and customers can audit us to ensure that we follow our standard operating procedures (SOPs) and that Viedoc is compliant with all regulatory expectations. Recently, Viedoc was audited for the 250th time since the initial release.
“It’s a milestone that should be celebrated since every audit is a verification of the platform’s quality and that Viedoc is being used in more and more organizations. At the moment we have also more audits scheduled than ever before, so here’s to another 250” says Henrik Blombergsson, COO at Viedoc.
The 250 audits have been done either on-site at one of the Viedoc offices in Sweden, Japan or China, remotely, or through third party audit reports.
To streamline the audit and evaluation process for both current and future clients, the Viedoc Product Specification outlines, explains and details all the features Viedoc commits to deliver.
Contact us if you are interested in either an onsite or remote audit or purchasing a third-party audit report. We ‘re looking forward to the next 250 audits.
GDPR – what happens with clinical research when Britain leaves the union?
On 25th May 2018 the General Data Protection Regulation (GDPR) came into effect within the EU – and soon Great Britain is leaving the union with what could be a “hard Brexit”.
Many of the responsibilities and obligations defined by GDPR are not new for companies in the clinical research sector, as similar requirements already exist in the regulations governing clinical research, such as ICH GCP E6 ‘Good Clinical Practice’. Many requirements are also similar to requirements to be found in local data privacy regulations in other parts of the world.
GDPR applies to companies and data subjects in the EU, but clinical research has become increasingly global in its scope and now a major clinical research member country is leaving the union. This article by Viedoc’s Quality Manager Alan Yeomans describes how different types of global clinical research projects are affected by GDPR and gives a detailed view of how GDPR applies to the jurisdiction of data subjects, sponsors and vendors.
Should patients be able to change their submitted data? And if so, who is allowed to make changes, when can changes be made, and how will it affect the balance between data authenticity and data quality?
Regulatory authorities recently issued a critical finding to a commercial ePRO vendor due to processes related to data integrity of ePRO data. One of the identified issues was that incorrect data submitted into the ePRO system could not be changed and were subsequently included in the study results. Requests to change the incorrect data had been submitted by the investigators but were rejected as it was explained that changes to the data could not be made.
In a new white paper, we discuss these issues in order to start reevaluating the traditional view that ePRO data should not be changed, and present the way we have chosen to address the possibility to correct ePRO data when using Viedoc.
Our commitment as an EDC vendor – here’s what you get
The Viedoc EDC system is designed to come with all the required and requested features of the clinical trials industry. Evaluating everything that Viedoc is capable of as well as its regulatory compliance can take a lot of time and work – time we’d rather see our clients spend on their clinical trials instead.
So, to streamline and simplify the evaluation and auditing process for both our current and future clients, we have created the Viedoc Product Specification. In this document, all the features that we commit to deliver are outlined, detailed, and explained.
Here is a selection of the features included in the Viedoc Product Specification, you can view the full specification in our new brochure:
An electronic data capture interface to collect CRF data in an ICH GCP compliant manner.
Regulatory compliance with clinical trial regulations according to FDA, EMA, JPMA and CFDA.
Regulatory compliance with the Personal Data Protection laws including GDPR (EU), APPI (Japan), HIPAA (US) and the Personal Information Security Specification (China).
A medical coding feature that supports MedDRA, WHODrug, ATC and Iyakuhinmei Data File (IDF).
Clinical Research and EDC in 2019 – What’s on the Horizon?
What will be this year’s major trends in the field of clinical research? Here’s Viedoc’s opinion of what will happen in the industry in the year to come.
The continued Rise of Patient Centricity and User Friendliness
Patient centricity has been a key factor in clinical trials for several years. A recent report from The Economist Intelligence Unit shows that patient-centric trials spend only of half the time to recruit participants, are able to recruit double the number of patients and the drug is 19 percent more likely to be launched.
“I’m not surprised by the results from The Economist’s report. There’s an old saying that the biggest trial of clinical trials is to recruit and retain patients. That’s still very much a truth and a key reason for why patient centricity will only continue to grow even more important in the coming years” says Henrik Blombergsson, co-founder and COO of Viedoc and continues:
“Patient centricity is not only about making the participation as easy, comfortable and undemanding as possible, but also that the study is designed with the patient in mind, and that it measures outcomes that are of value and use to the patients and society as a whole.”
The intensification of interoperability
Integrating various systems, wearables and other new sources of data is becoming increasingly important. At the start of last year, HL7 announced the release of a new version of the FHIR standard (Fast Healthcare Interoperability Resources), a framework whose purpose is to enable interoperability by simplifying the process of moving, sharing and collecting health data. FHIR is already in use in the US, making it a global standard would revolutionize the entire health care sector.
“A standard such as FHIR enables information transfer between different e-service platforms and business systems, for example between an EDC and an EHR. Ultimately, this allows clinical researchers to collect anonymized, relevant data straight from medical journals without having to transcribe it. This won’t replace the current way of collecting data from study-specific patients, but it’s a complement that will change how data is collected and shared”, says Sverre Bengtsson, co-founder of Viedoc.
Interoperability is also closely connected to patient centricity since one major effect is a transition of the data collection process from the clinic or hospital to the patients’ everyday life, but it’s also a way for researchers to collect relevant data every minute, or even every second.
“When we started working in the field, data collection was performed once every week or month. With the possibility to collect real time data continuously without any increased efforts from the patient, researchers can get a whole new understanding for the patient and for what is being measured”, says Sverre Bengtsson.
Accepting the cloud
2019 will be the year when the usage of cloud solutions is fully accepted by the clinical trial business, according to Jens Pettersson, Technical Fellow at Viedoc. The former scepticism about data information security when using cloud services is rapidly transforming into trusting that cloud vendors have far greater resources and skills in keeping data safe than local on-premise solutions. Compliance with local and regional regulations, like GDPR in the EU, and technical and contract solutions for regional data storage are also paving the way for cloud solutions. And of course the basic foundation of the cloud solution idea that centralized data operations will offer clients a more cost-efficient service with higher availability.
“The biggest challenge now is on the cloud vendors to establish trust and guarantee that foreign authorities and intelligence agencies, with respect to both data locality and data subject origin, cannot silently tap into and monitor data, but that local and regional regulation and legal processes must apply for such inquiries”, says Jens Pettersson.
The Viedoc Pricing Policy - this is how we do it
We at Viedoc have a vision – Everyone wants to and can use Viedoc. We therefore promise to try to fit our pricing to each individual study.
To do that, we created the Viedoc Pricing Policy to have a fair and clear pricing structure that fits each study to ensure no one pays for services they don’t receive.
Always set the right price.
An important step in reaching our vision is to set the right price - for every study.
We always wait until you are ready. License fees are only invoiced after the first patient has been added to the study. Pay as you go. Simple.
The main principles of Viedoc Pricing:
The size and complexity of your study determine the price.
The larger and more complex the study the lower cost per parameter.
You get what you pay for and never pay for more than you get.
We know each study is unique, so we work with individual and unique license fees based on a few different study parameters: the duration of the study, and the number of subjects, sites, visits, and unique forms. To ensure the pricing fits even better we also consider the phase, type of sponsor among other things.
No fixed price list
Because we match the price to the study Viedoc has no fixed price list - so anyone who wants to, can use Viedoc no matter the size or complexity of the study. Our pricing always includes maintenance, hosting, backups and technical support. In other words, we have no hidden fees.
Additional components (ePRO, Medical Coding, Randomization)
To ensure the pricing fits your budget Viedoc has several add-on features that can be included if needed. For studies that don’t need extra functionality these features don’t need to be paid for. If your study requires these features, they can be added to the licensing to suit your study.
No hidden costs, no risks, only what you need is included.
Viedoc and late phase studies – the perfect match
Late-phase studies are growing! And they are doing so by almost every metric: size, complexity, popularity, and simply the number of studies. However, they are not growing because they are easy to implement! Indeed, recruiting a representative sample for such studies typically globalizes the project, creating many challenges, such as navigating different languages, regulatory environments, social healthcare systems, third-party vendors, etc. Additionally, some investigators may have no prior experience in clinical research or the processes and technology involved. Thus, when preparing to start a late-phase study, sponsors must begin by making some long-term decisions about their organization and study management tools – particularly regarding e-Clinical technology. These tools need to be user-friendly (for both patients and research staff), efficient across several modalities of data collection (safety, efficacy, outcomes, quality of life, etc.), compliant with multiple regulatory agencies, able to integrate with external systems, and obviously – worth their cost.
Why Viedoc when it comes to late-phase trials
An EDC system is essential for collecting and managing the ”big data” generated by large, late-phase trials across different countries and many sites. The below table summarizes the essential characteristics and requirements in late-phase studies and how Viedoc is the right tool for the job:
Characteristic / Requirement
Robustness, scale, globalization
Viedoc is used extensively and successfully in late-phase research globally. The system language is currently translated into 14 languages and additional languages can easily be added upon request. The eSource tool, ViedocMe, can be translated into any language.
Viedoc is compliant with all major regulatory agencies, e.g. GDPR, FDA 21 CFR Part 11, ICH GCP, GAMP 5, HIPAA, APPI (Japan), PI-Specification (China). Moreover, our QA department plays a leading role in the eClinical Forum – an industry group which consolidates regulatory requirements from all over the world. Thus, Viedoc is “in the know” when it comes to best practices for clinical research – from global to local levels.
User-friendliness / Usability
Viedoc has an intuitive and modern interface that is as good-looking as it is functional. It’s designed with the user in mind – both easy to understand and use.
Training / eLearning
Viedoc’s eLearning contains step-by-step instructions, video tutorials, use-cases, training sites, and even prototype “sandboxes” for the study builders.
Flexibility for complex protocols and amendments
Via a drag-and-drop interface and simple programming functions, Viedoc allows study builders to easily design an eCRF at any level of complexity. Even after the study is live, the eCRF can be updated with whatever changes are necessary.
The Viedoc API facilitates the communication between external systems and the eCRF. Data can be pushed in or pulled out, as needed. Typical uses are for a Clinical Trial Management Systems (CTMS), an external system for Risk-Based Monitoring, a tracking system for drug supplies and payments, central laboratories, etc.
eSource / Patient device
ViedocMe is the “app” for the patients to use to submit QoL data or any other data you want to collect directly from the patients. Add reminders (SMS and/or email) to ensure and increase compliance. Everything is translated to the local language of the patient.
Viedoc allows full visibility and control over the data collection process. A variety of queries and alerts can be raised on questionable or important data. Built-in graphical metrics and 24/7 access to data export provides a constant and thorough overview of the study.
Through Viedoc Admin, the Sponsor or CRO can supervise and control study access and provide first-class site support sites and users. For advanced issues, our in-house specialists will assist from our offices in Europe, China, or Japan.
Viedoc’s inbuilt randomization feature allows for both static and dynamic randomization of any complexity. Single kit assignments are also possible.
Viedoc is a premium EDC available at a significantly lower price than competing products. Viedoc is priced to match the complexity of the study and no license fees are billed until the first patient is enrolled.
Improved site support by removing the help desk – a true Viedoc story
Should a centralized helpdesk provide tech support for studies all over the world, or should a small team from each study with full knowledge of the protocol solve technical issues directly? This was a major discussion point within the Viedoc team when we were redesigning the platform in early 2013. We found that a majority of the issues sent to the help desk tickets were minor technical issues, which took an unnecessarily long time for an unfamiliar technician to solve. A centralized help desk generally has non-specific knowledge about the study protocols, as well as no personal relationship with the site in question. Thus, each case started with an extensive and repetitive dialogue before getting to the actual problem at hand. Additionally, centralized user management also required complex and time-consuming workflows.
With the above in mind, we simplified the support processes by developing a completely new application – Viedoc Admin. The purpose of the application was to provide flexibility for the management of sites and users, and introduce these responsibilities to users not normally involved in these tasks – users that also already had a connection to the site. Hence, a new system role “Site Manager” was developed.
The addition of Viedoc Admin means that users no longer have to wait for the help desk to be able to add a new user, reject a user that no longer should have access or reset a password for a user that has forgotten the answer to the challenge question. For example, a monitor can be a self-sufficient manager for all of their sites, with control over each user’s status and activity. Thus, our clients are able to appoint one or several study and site managers to each project with direct access to Viedoc Admin. And they can guarantee that someone knowledgeable about the study is available to solve support issues instantly and without relying on a centralized helpdesk that may only operate in one time zone. Meanwhile, at Viedoc headquarters, we are able to specialize on the advanced technical issues from our clients (integration solutions, developing new features, etc.).
We have confirmed our vision for support in a recent survey of Viedoc users, where over 85 percent of the respondents replied that site support was improved or greatly improved by managing user administration themselves compared to when it was managed by a centralized helpdesk. The respondents especially highlighted that the site manager role allows faster, simpler and more direct solutions to minor issues.
A comparison of the traditional helpdesk and the Viedoc site manager role can be found below.
Speak local language
No relation with site
Personal relation with site
Low knowledge of protocol
High knowledge of protocol
In Viedoc the investigators always have access to their data
The ICH GCP R2 requirement states that "The sponsor should ensure that the investigator has control of and continuous access to the CRF data reported to the sponsor. The sponsor should not have exclusive control of those data."
Whether or not the investigator has control of and continuous access to their data is not a function of whether or not the servers are remote, but of other aspects as well:
Are these servers under the control of the sponsor? For example are they servers owned and operated by the sponsor?
Does the sponsor regularly disable investigator access to their data, for example after database lock?
Viedoc servers are under the sole control of PCG Solutions who are a trusted third party, the data is not under the exclusive control of the sponsor. After database lock the investigator can still logon and view all of their data in Viedoc, they are no longer allowed to change their data but the ability to change the data is not demanded by ICH GCP, only that the investigator should have continuous access to it.
At PCG Solutions we are active not only in following all relevant international regulations and guidelines, we work actively with the authorities to ensure that we have a full and correct grasp of their expectations and we develop and test Viedoc to ensure compliance. Viedoc Performance Qualification (PQ) contains a special regulatory test suite that is executed on every release of Viedoc to ensure that the regulatory compliance has not been compromised.
You do not need to export PDFs to store at the site, Viedoc guarantees that your investigators have continual access to their data at all times.
If you have any questions regarding the interpretation of this requirement, do not hesitate to contact us.
Pfizer, China and 250 000 patients – the major Viedoc milestones during the first 15 years
Want to know what we have been doing for the last 15 years? Here are the milestones that reshaped the EDC-market with a straightforward software-as-a-service tool.
2003 It’s all about the looks
The idea behind Viedoc was born in Uppsala, Sweden, by two former CRO-colleagues after winning a competition held by Sweden’s largest real estate company. The prize was a rental free office for 6 months which gave the business a kick-start.
The business idea was to bring freshness to the outdated world of clinical data capture with a software that was not only nice to look at but also easy to manage and use. The first version of the software was released in 2004 which enabled the team to start offering EDC-services to local marketing and biotech companies as well as academia.
2008 First big killer contract
Pfizer, the world’s biggest pharmaceutical company, put their trust in Viedoc – it all happened as a result of a coincidental meeting at Charles de Gaulle Airport in Paris. One of the founders was waiting for his flight back home to Sweden and started a conversation with the woman next to him who coincidentally was in the same line of business and was about to purchase an EDC-system. After several demos for skeptical Pfizer-employees in Stockholm the team travelled to New York and it became clear that Viedoc outperformed two big US EDC vendors. Thanks to the flexibility and ability to add required new features to the Viedoc platform – the deal was sealed and Viedoc got the respect and trust of being a supplier to a major pharma company.
2009 Oh – big in Japan
As the team expanded, a previous CRO colleague was hired responsible for investigating Japan as a new market. Although he was skeptical at first, the Japanese business soon took off. The new concept was to provide training sessions allowing the customers to be able to configure their own studies in Viedoc. Up until this moment, all of the study configurations had been done inhouse. Because of the successful training, customers in Japan started setting up and using Viedoc on their own. As a result, the Viedoc network grew rapidly making Japan the single most important market for Viedoc in just a couple of years.
2011 50 countries – a milestone
Offering a Software-as-a-Service solution you have to take into count that countries and regions are at different levels of maturity when it comes to using online services. Because of word of mouth Viedoc managed to get footprints in various countries and markets with very different digital skillsets. Viedoc is currently available in 14 languages including all the big ones in the world, from English to Mandarin, French and Japanese.
2012 VieBee, the bee is born
Our mascot, Viebee, has all the qualities that we love: flexible, hard working and spreading prosperity and harmony. It all began when we started to think about redoing the whole platform from scratch, which later resulted in the second generation of Viedoc. Viebee was born in the same emerging thoughts and ideas that created the new version of Viedoc. As we like to work with imagery and try to capture the essence of our system in images rather than traditional it-architecture, the Viebee became our visual spokesperson helping us share our slogan “Enjoy Your Trial”.
2013 A brand new platform was needed
Viedoc, at that time, was just not good enough. We needed to dive into deep water, start from scratch and build a whole new platform not re-using a single row of code. Such ventures cost money. We started a whole new development team and soon focused on releasing a basic product that we could get into clinical trials as soon as possible practicing an agile progamming – and business – development model working with real customer feedback. We pushed product releases every fourth week, a crazy speed for a relatively small company like Viedoc. We have pushed 42 new product releases of Viedoc since then.
2014 Did anyone mention audit?
We love audits. The reason is pretty simple: being audited means that you have business. In 2014, when we passed a magical number of 200 audits, we started to realize the amount of work an audit actually requires. With the updates of GCP in 2017 it is now a requirement for sponsors to do audits before taking on a new EDC vendor. We facilitate this requirement by providing an independent quality report that customers can buy, saving both time and money.
2015 250 000 patients – another milestone
Business kept growing and all of a sudden a quarter of million people had gone through our system. We try to think that this is merely the beginning – trust, regulations and legislations are somewhat slowing down the speed that our restless souls would like to travel at but from zero to a quarter of a millon people in about ten years time is pretty ok anyway.
2015 China – so much down our alley
The Chinese market is really our style of doing business. We soon learned that Chinese sponsors have a great appetite for large scale studies while at the same time being concerned about efficiency and costs. Starting business in China takes time, it requires establishing a local Chinese company and personal relations are key for long term commitments and business success. The Chineses business mentality suits us and we are convinced that China will be a big part of our business in the near future.
2018 GDPR – no problem!
Why wait for the storm to come? With GDPR coming into force on May 25th 2018 we had already done most of the homework. Both China and Japan have similar requirements. Apart from adding encryption for data in storage and enabling users to approve access, delete accounts, study memberships and data from completed studies we have also added an option for two factor-authentication when logging into Viedoc. Everything is done to keep our client’s data as secure as possible. While at it, we also created a new client agreement regulating data processing and data privacy making sure everyone knows who is responsible for the data.
It’s all talk. Here is how Viedoc walks GDPR
The buzzwords and GDPR strategies are flying around as enforcement day of May 25 is approaching. Here are the concrete steps we have taken to nail compliance with the new regulations. And by the way - our flexible platform made the work rather easy.
Encrypted data storage
We have always encrypted all sending and receiving of data. But we felt that it was not enough. We have now chosen to encrypt the data at rest, when stored in our data centers.
GDPR is demanding “appropriate level of security” when it comes to transmitted, stored and processed data. Encryption of data is one example (not requirement) that legislators have identified as appropriate level of security and we have taken this advice seriously and encrypted all data at rest.
Two factor authentication
From now on, sponsors can enforce two factor authentication for logging into Viedoc. You can either do this by receiving a confirmation code by e-mail or an SMS making it harder for unauthorized people to access data in Viedoc.
GDPR is demanding “appropriate level of security”. Sponsors and users can now decide themselves on the level of security necessary for user authentication in their study.
The right to be forgotten – in Viedoc
We are now empowering Viedoc users to control who can see the personal information stored as part of every user account. Users can now delete their own study membership and their user account. Certain study management roles are also able to delete the data from a completed study. All of this was previously a manual and time-consuming process and can now be done in a couple of clicks.
GDPR is stating the right to be forgotten, or deleted, from a register or database. The controller, or study sponsor in clinical trials, is responsible for this. We have made it possible for the user to do this in an easy and efficient manner. We have also empowered investigators to decide which study he or she wants to participate in, protecting their user data.
GDPR enforces us to make it clear what responsibilities our clients have and where we step in and take responsibility of stored data, clarifying what data is exchanged, the purpose of doing so, how it is handled and what protective measures have been taken. This applies to both the business side – client agreement – and the user side - terms of conditions.
Definitions – who is doing what in the world of GDPR?
What kind of data are we talking about?
GDPR is – when it comes to clinical trials – all about keeping control of contact and user data from sponsors, CROs and clinical staff. Study data is stored pseudonymised and the data is collected according to clinical study regulations like GCP making GDPR only applicable in certain areas.
Controller is the study sponsor – biotech company, academia or pharmaceutical company. The controller owns the data and is therefore responsible for the data, but the platform vendor is the controller of the user accounts. Sponsors can’t be controllers of the user account as investigators can work in Viedoc with several different studies for different sponsors and there should generally be only one controller of the specific data.
Processor is another term that you need to know about. It’s usually the CRO in the world of clinical studies. The CRO is processing the data for the study.
Doctors and clinical staff are in most cases the users. They fill in study data – and their personal data in the Viedoc platform.
Regulatory aspects on EDC systems
Investigator-independent copy of the data
There is regulatory concern whether data collection in the EDC systems of today meets the requirement of a contemporaneous, certified copy that is not under the exclusive control of the sponsor. The requirement originates from the EMA eSource reflection paper: EMA/INS/GCP/454280/2010 “Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials” (June 2010). Link
The FDA also explains this requirement on Electronic Source Data: “Guidance for Industry – Electronic Source Data in Clinical Investigations” (September 2013). Link
Both the EMA and the FDA have stated publicly that the EMA eSource reflection paper and the FDA eSource guidance are equivalent to each other and place the same requirements on clinical trial data, and that any differences between formulations in the documents are merely due to the different judicial climates that the authorities must cater to in Europe and the US.
The requirement was also further emphasized with the recent update of GCP (June 2017). Link
Before explaining how Viedoc assures an independent, contemporaneous copy of the data, one should understand how data has been recorded historically and what led to this requirement. With that background in mind, one will see that the requirement is more accurate today than ever.
How the data collection process has changed over the years
In the past, before ICH-GCP was established, CRFs consisted of a single, master copy – on paper. Thus, tracking changes and data edits was practically impossible. When ICH-GCP was introduced it required that a copy of the data should be kept at the investigators’ site, and the original at the sponsor. The No Carbon Required (NCR) CRF was developed to ensure an exact copy of the CRF. The NCR CRF consisted of three papers: one white (the original, normally sent to the data management department for performing data entry), one yellow (the sponsor’s copy), and one pink (the investigators’ copy, which stayed at the site).
Although the NCR CRF was indeed an improvement, the process to complete, collect, transfer and enter the CRF data at the sponsor was very time consuming (especially if the ink from the white copies didn’t bleed through to the yellow ones – a constant problem requiring clarification). To get faster access to data and to decrease the number of errors/clarifications, Remote Data Entry (RDE) systems were developed. In these systems, investigators, nurses, and study coordinators entered data directly at the site. The RDE systems were installed locally on a computer and data was periodically transferred to the sponsor. While the RDE systems had their own shortcomings: deployment, installation, support, usability and cost, this was certainly an improvement over the slow, fallible, and messy paper records. A copy of the data was also always available on the local RDE machine used for data entry.
Soon after the internet opened for general use, web-based EDC software was introduced. This improved the data entry process even further, as sites could simply use their own computers and send data directly to the main database. The EDC landscape has continued to evolve, and today data is available as soon as the investigator hits save, and data can be reviewed, queried, clarified, locked and signed off almost instantly (i.e., in real time).
Regulations state that the archiving of eCRF data is the responsibility of the investigator. The current practice of archiving is to burn a PDF copy of the data on DVDs or Blu-rays and then mail the disc to the site. The investigator must then approve and verify that this disc does indeed contain the data that was entered. The problem with this approach is that the disc doesn’t contain a copy of the originally-entered data but rather a print-out (essentially a screenshot) of the database in the form of a PDF. Regulators from governing bodies around the world have variously been uncertain that such copies truly reflect reality (i.e., match what was physically entered/approved by the site).
How is Viedoc different?
Viedoc provides a contemporaneous PDF copy of the data at the same time as the data is saved. Moreover, the data is not stored on a server under the sole control of the sponsor, but within Viedoc’s servers, where the investigator can access it at any time (the legal equivalent of storing it at the investigator site). Alternatively, generating PDFs at a later date (which is done by many other EDC systems) means that they are not contemporaneous, and thus do not fulfil this requirement.
Furthermore, the requirement applies to all data within the eCRF – not just a subset of data, (e.g., what some consider “eSource”). Because Viedoc provides contemporaneous capture of the entered data on PDFs at the time of data entry, the sponsor does not need to involve other systems in the capture and archiving of source data that is entered or transcribed to the eCRF.
For more information on Viedoc’s regulatory compliance, please contact us.
Top 6 things customers love about Viedoc
We’ve assembled a list of the top 6 things customers around the world love about Viedoc.
Starting with the most popular comment:
User friendly/Easy to navigate
Viedoc looks and acts like a modern web application (because it is!). Viedoc was designed to be intuitive for all users, and save time performing any day-to-day activity.
Ease of set up, quick eCRF setup
Through Viedoc Designer, the time to build and setup a study from start to completion is done in days rather than months. Being a certified study builder allows you to control and perform this process in-house, saving both time and money.
Viedoc is built to facilitate the work for all users
Whether you are responsible for a Clinic, Admin or Designer activity, Viedoc makes you fast, accurate, and efficient. All workflows are developed to enable maximum output with minimum effort.
Best value for the money
Our motto is, “Everyone wants to (and can) use Viedoc!”. That motto includes the price. Whether you’re a start-up, a university, or a large CRO – we want you to have the best EDC system money can buy.
Viedoc is modern technology running on modern hardware and built for handling all kinds of data. Thus, you can depend on the highest speed your internet connection will allow, without lag or waiting for the system to save your actions.
Minimal required training
With access to a prototype environment, text-based eLearning, and even video tutorials, a standard user can be fully-functional within an hour, and a study-designer within days.
There are many more appreciative comments about our EDC system and we are grateful for all the reviews our customers give us.
We add features to our product on a near-monthly basis. This is because in addition to our team of study builders and support staff, we employ an entire development team specializing in making Viedoc better. We also host active User Group meetings to listen to our customers about their needs, as well as show them what’s new. All of the above and more is what makes Viedoc the #1 EDC product in the world.
Things to consider when collecting data from patients using ePRO
Patient self-reported data is playing a key part in efficacy, quality of life assessment and safety data collection in clinical trials. Bring Your Own Device, aka BYOD, enables a patient to capture such data on a device the patient is already familiar with, e.g. a smartphone, tablet or computer.
ViedocMe, our web-based ePRO solution, is an integrated part of our EDC platform Viedoc and allows patients to report clinical trial information directly from their mobile devices into the eCRFs available in Viedoc. Thanks to the integration, deploying a study diary and/or questionnaire in ViedocMe is not only more cost-effective than traditional ePRO trials, but can also be done in much less time.
ViedocMe builds on our vision of the future for how to handle patient reported data. For more information and a comparison between different solutions, see our white paper “The Future of ePro Platforms”, written in 2015 and still accurate.
Why nominate for the Viedoc Most Valuable Professional Award?
The passion born from improving electronic data capture for clinical trials is still our greatest goal and this has made us a leading provider in the industry. This goal can only be accomplished by the communication and collaboration we have with our users. That is why we have now introduced the Viedoc Most Valuable Professional (Viedoc MVP) award. The Viedoc MVP is given for outstanding contributions within the Viedoc community and to acknowledge those who are willing to share their passion, technical expertise and real-world knowledge of Viedoc, electronic data capture or clinical trials. A Viedoc MVP is awarded for individual contributions and the nominees are selected exclusively by the PCG Solution’s management team based on a review of accomplishments and achievements.
This year, we have given our first Viedoc MVP award to Makoto Yokobori at the User Group Meeting held in Tokyo on 13 June. Mr Yokobori was the first user to get our back end set up training back in 2008. Since then, he has gained and shared in-depth knowledge from all aspects of conducting clinical trials using Viedoc. Mr Yokobori is a true ambassador for good clinical practice and includes this thinking in the study design and how systems can best be incorporated to support and raise the quality of the study. He is full of ideas and has a strong interest in improving and developing the industry, much like why Viedoc was born.
White Paper: Preparing for the EU GDPR in Clinical and Biomedical Research
On the 25th of May, 2018 the new European Union (EU) General Data Protection Regulation (GDPR) comes into effect. Everyone who does business within the EU must follow this new regulation. PCG Solutions is a European company, and is subject to GDPR.
GDPR requires companies to have control of their information management and its governance. In the Clinical Research sector this has long been vital for the success of clinical drug development, so it is not a pivotal change to how companies work. Instead companies need to ensure that their internal policies are aligned with the regulations defined in GDPR.
This white paper explains what GDPR is, the responsibilities and obligations it entails and how it affects you in your dealing with the EU and with PCG Solutions. PCG Solutions customers cover the entire range of companies from those active in the EU with natural persons based in the EU in their studies, to the opposite extreme where the only contact with the EU is PCG Solutions itself. This white paper covers all scenarios so that no matter what your connection to the EU is you can easily see how you are affected.