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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!"
Clinical Data Group Leader, Specialty Franchise Clinical Operations / Ipsen
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."
Special Advisor, Data Management / Oslo University Hospital
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."
Associate Director, Biometrics / Novotech
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."
Manager, Viedoc Projects / Zifo RnD Solutions