EMPOWER YOUR CLINICAL TRIAL

What was done?

Ipsen is a global specialty-driven pharmaceutical company headquartered in Boulogne-Billancourt, France. Viedoc was selected as the EDC system to be used for a global non-interventional study where the main challenge was the complexity of design: many fields and forms being triggered based on complex visibility conditions. The study setup was done by one of the Viedoc study build teams.

How did it go?

"The eCRF for the study went live last week. This short message is to thank you personally for the excellent quality of the work done with the eCRF set-up for the study. You have managed to address a very challenging design, you brought added value and we thank you for that. Please be informed that investigators to whom we have presented the eCRF were very enthusiastic!"

Philippe Greve
Clinical Data Group Leader, Specialty Franchise Clinical Operations / Ipsen

Background

Oslo University Hospital is Norway’s greatest hospital with over 20 000 employees. The hospital is by far the biggest contributor to medical and healthcare research conducted at Norwegian hospitals. Viedoc won the tender for an EDC system based on requirements for use, data protection and price. The contract was signed and the team in Oslo was trained by a Viedoc Product Specialist. The training covered study build and general management / administration of the Viedoc platform. The Viedoc Support was also available to answer any questions the team had after the training was completed.

How did it go?

"After 6 months we have 6 studies in production and 3 more are in the final QC-stage. 2 new studies are currently being built and 8 more are in the pipeline. Not bad for being the first 6 months with a new platform."

Cecilie Moe
Special Advisor, Data Management / Oslo University Hospital

Background

Established in 1996, Novotech is the largest independent Australia based Clinical Research Organisation (CRO). With headquarters in Sydney and operations in 12 countries, Novotech's service offering has come to be recognised for its quality both by the clients, as well as industry analyst groups. Novotech is the only Australian CRO with ISO 9000 quality credentials. After evaluating a number of different products, Novotech selected Viedoc as one of its key EDC solutions based on the ease of use and flexibility of the system especially for adaptive trial design studies.

How did it go?

"Viedoc is easy to use, web-based and has an excellent user interface. This intuitive design makes designing case report forms a lot easier for complex SAD and MAD studies. The additional Randomisation functionalities meant that complicated randomisation schedules and stratification could also be added to trials. After the initial training provided by Viedoc, Novotech designed 12 studies in the first 12 months. Managing 80 sites and over 240 subjects in a single trial is a huge task in itself, but this was implemented with ease in Viedoc. The eCRF works extremely well and we have received excellent feedback from study coordinators and investigators."

Andries Claassen
Associate Director, Biometrics / Novotech

Background

Zifo RnD Solutions is a Specialized Research Data Management service provider with expertise in Clinical Data Solutions, Discovery & Lab Informatics, Computer System Validation and Consulting Services for a regulated environment. Over the past five years Zifo has configured over 100+ Viedoc studies for different phases. A ZIFO team was certified in study build by taking the Viedoc advanced system training in Tokyo which is a training held regularly by Viedoc's Japanese office. Today ZIFO has a team of 20 people working regularly with the Viedoc platform.

How did it go?

"I find Viedoc a simple to use EDC platform with an intuitive user interface. It is easy to build a study and quick to set-up different components like the integrated ePRO (ViedocMe), lab data upload (Helipad). The system helps address even the most challenging designs which always makes the sponsor happy. Many sponsors who have worked with us also find the different features that are part of the EDC system itself very helpful during the study conduct phase."

Divya Suryanarayanan
Manager, Viedoc Projects / Zifo RnD Solutions

Background

Nutricia Research is the global R&D organization behind the Early Life Nutrition and Advanced Medical Nutrition divisions of Danone, sharing its global mission to deliver health through food to as many people as possible. In 2015 Nutricia Research decided to search for a preferred partner for an Electronic Data Capture System (EDC) as a cloud- or web-based solution that would meet privacy and regulatory (e.g. 21 CFR part 11) compliance for all clinical studies. Nutricia Research also intended to build the electronic Case Report Forms internally, using the selected cloud- or web-based EDC system. After a tender Viedoc was awarded the contract in January 2016.

How did it go?

Twelve people from the Nutricia Research Utrecht- and Singapore offices participated in a web-based training over 3 sessions. The web-based training was provided by a Viedoc Product Specialist. The training covered study build and general administration of the Viedoc platform.

"We were all very much involved in building the Nutricia templates and the team is really enthusiastic. We adopted daily SCRUM meetings and SPRINTS for the implementation. This proves to work very well."

Hanneke Lankheet
Team Leader Data Management, Clinical Studies Platform - Biometrics / Danone / Nutricia Research

Background

Neuromod Devices is a medical device company running innovative clinical trials to treat the symptoms of tinnitus. Viedoc was chosen as the EDC supplier for our multi-site interventional study. As a start-up we opted to design and develop the application on our own.

How did it go?

"The Viedoc system is very easy to navigate and develop, particularly for a team of naïve developers. The team at Viedoc were extremely supportive throughout our development process. Developing the application ourselves allowed us to implement the various innovative aspects of our trial and make changes in an efficient manner. Our team of clinicians finds the application extremely easy to use and the flexibility meets the requirements of our studies."

Dr. Shona D’Arcy
Chief Scientific Officer / Neuromod Devices

What was done?

Blueclinical is a translational medicine company devoted to the development of medicines and medical devices. Blueclinical Phase I's mission is to conduct effective studies in healthy subjects and early stage studies in patients, in full compliance with the international regulations. Viedoc was selected among a list of EDC vendors andBlueClinical’s team was trained on study setup in early 2014. The training was performed during 3 days in Porto by a Viedoc Product Specialist.

How did it go?

"Since the training in early 2014, we have built and launched 33 projects using Viedoc. As we do very similar studies, the possibility to save and use templates in the study build process is of high importance to us. We are very happy having chosen Viedoc as our EDC platform."

Cristina Lopes
Clinical Operations Director / Blueclinical

Background

Based at Peter MacCallum Cancer Centre for over 40 years, the Centre for Biostatistics and Clinical Trials (BaCT) provides a full range of services to clinical trials to facilitate the advancement of patient treatments and improved outcomes for cancer patients. BaCT provides and coordinates trial management, data management and statistical support. In 2015, BaCT selected Viedoc as its eDC solution to design and develop trial databases.

How did it go?

Over 3 years we have developed and launched 14 trials in Viedoc and have a number currently in development. The eDC solution has been easy to use for database development, data entry and data validation. Viedoc has been an introduction to electronic data collection for a number of our investigators and staff and Viedoc is so user-friendly that the transition from paper was almost painless. The user interface is aesthetically pleasing and has received great feedback from site staff. In addition, the Viedoc team have very supportive and consistently respond to queries promptly.

Alison Hall
Business Planning & Operations Manager, BaCT / Peter MacCallum Cancer Centre

What was done?

Kun Tuo, as the Contract Research Organization (CRO) specially set up in Chinese market by IQVIA,is dedicated to provide high-quality and reliable service for clinical studies registered in China and innovative drug investigations. As of May 2012, Kun Tuo has provided professional clinical study service for many famous domestic and foreign pharmaceutical and medical device companies. Full clinical study services provided by Kun Tuo include: Regulatory Affairs, Strategy and Consulting, Clinical Operations, Project Management, Medical Affairs, Medical Translation, Biostatistics, Data Management,  Clinical Safety Management, Site Management (CRC),  MedTech Delivery etc.

How did it go?

The IT support team from Viedoc is efficient and we have the unimpeded communication. The quick response and advice for the encountered problems impress us. We look forward to continuing the relationship with Viedoc in more fields in the future.

Nicole Weng
Associate Director, Clinical Data Management Department / Kun Tuo Medical Research and Development (Beijing) Co., Ltd.