By Ven Thangaraj, CTO, Acceliant
The selection process for utilizing electronic data capture (EDC) is thorough, challenging, and time consuming. It is conducted with qualified individuals and teams reviewing systems that appear to meet various functional requirements and display the necessary performance on stability and performance. A pharmaceutical, biotech, CRO or a medical device manufacturer invests considerable time and money in the selection process. Ultimately, a decision is made and a platform is selected.
The decision carries with it many implications for the organization and its eco-system of partners before and during the clinical trials. The decision will impact the end result data report. An entire eco-system must be trained and oriented towards a new system, including its processes, reporting tools, and various controls in handling trials. Each of these aspects involves credibility and a time and effort investment by all involved in the clinical trial.
During trials, however, if these systems do not consistently meet the requirements of an initial study or are too rigid to meet the changing needs of more complex long-term studies, it will leave the EDC client in a difficult situation. The client can neither continue the studies smoothly nor easily switch to a new platform due to the ‘vesting’ in a current platform and the risks involved.