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The business idea was to bring freshness to the outdated world of clinical data capture with a software that was not only nice to look at but also easy to manage and use.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.
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.
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.