The development of an eCRF for your clinical trial

Clinical studies are an important part of drug development globally. The number of registered clinical trials has increased significantly in recent years. As of February 1, 2021, there were around 366,000 clinical studies registered globally. The number of clinical studies has increased significantly since there were just 2119 registered in 2000. In general, clinical trials have grown more complex in recent years and remain vital for the research and development of new drugs and products.

Over the last 20 years, with improvements in technology, there has been a move towards using more cloud-based systems during a clinical trial. Moving away from paper Case Report Forms (CRF’s) to Electronic Data Capture Systems (EDC), the use of Electronic Trial Master Files (eTMF) for all clinical related documentation, Clinical Trial Management Systems (CTMS) Medical coding software are just to name a few.

In the long run, it’s been proved that using EDCs and eCRFs provides much greater advantages than using traditional paper based methods.

  1. Using eCRFs for studies can be much more cost effective.
  2. Data stored in a cloud-based system is more secure than on paper
  3. There’s not as much training required as you think.

This series of blogs will take you through the development of an eCRF process, giving you hints, tips and considerations for you to think about.

  1. First steps when initiating the development of an eCRF system 
  2. Requirements and considerations when developing eCRF pages
  3. How can nowEDC enhance user experience?
  4. Reporting in nowEDC
  5. The importance of UAT and what is required from the customer
  6. Changes to a live eCRF
  7. What will happen to my data at the end of the study?

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