Electronic data capture (EDC)--a new mantra for clinical trials.
Pharmaceutical companies, over a period of time, have attempted to use innovative and modern technologies for quicker and more efficient methods of clinical data capture and analysis. In today's scenario, Electronic Data Capture (EDC) is considered to be the preferred technology that can provide significant benefits over existing manual methods. This article highlights the lacunae of the traditional data capture method and discusses the advantages of using EDC for better data quality, improved performance and productivity, and reduced cost in clinical trial management. It also emphasizes the need for IT infrastructure, training, and 21 CFR Part 11 compliance issues. The authors have also described the challenges to be faced by the investigators and sponsors in implementing EDC. Finally, the article concludes emphasizing the fact that EDC is the future mantra for the clinical trials and all stake holders should face challenges of infrastructure, technology, regulations, and training to make it a success.
Sahoo
Umakanta
U
ClinInvent Research Private Limited, A-302 Everest Chambers, Marol Naka, Andheri-Kurla Road, Andheri (E), Mumbai 400-059, India.
Bhatt
Arun
A
D002986:Clinical Trials as Topic; D003625:Data Collection / Q000379:methods*; D004345:Drug Industry; D001330:Electronic Data Processing; D011786:Quality Control