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Electronic clinical trials have come into vogue in the clinical trials management system. Simply put, an electronic clinical trial is an automated system that tracks the entire documentation history and trail of a clinical study.
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Electronic clinical trials have come into vogue in the clinical trials management system. • Simply put, an electronic clinical trial is an automated system that tracks the entire documentation history and trail of a clinical study.
Features of electronic clinical trials • Maintaining and managing system planning is the basic function of electronic clinical trials • They help the healthcare or biotech organization to perform and report their functions • In addition, electronic clinical trials also contain contact information about the participants in the clinical trial, and help the company track important milestones and deadlines.
The rationale for electronic clinical trials • As the nature and complexity of clinical trials have gone up in recent times; sponsors (those carrying out the research) have to work with more number of clinical sites. Some of these are spread over many countries and across varied service providers who are many times located equally far and wide.
Advantages of electronic clinical trials • The electronic nature of these eTMFs offers an easier and more secure way of sharing all documents relating to the clinical study, and carries some benefits or advantages over paper documentation: • Clinical trials organizations need not have the fear of loss or destruction of eTMFs • eTMFs are easily accessible in any site across the globe in real time, unlike paper documents that have to be transported to a particular site, which could sometimes be located in another continent.
Challenges associated with electronic clinical trials As with any technology, while eTMFs offer manifold advantages, they also bring in their wake some issues and challenges. The main challenge relates to security. The remedy to this challenge is to put checks and controls at every stage, which is time consuming and complex.
