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Newsletter - May 26, 2016

Clinical Trial Recruitment Planning: FDA and Others Provide Tips and Tools  

Challenges in recruiting patients are the most common reason for delays and increasing costs of clinical trials. This week the Clinical Trial Transformation Initiative (CTTI), a joint program between FDA, Duke University and industry representatives, announced recommendations for creating robust recruitment plans for clinical trials taking into consideration the most common challenges and potential solutions. Read More..

Digital Tools in Clinical Trials Increase Trial Efficiency and Reduce Errors

The latest trend in clinical trial automation is use of BYOD, “Bring Your Own Device”, where a trial participant’s smart phone can be used to collect critical trial activities and data points such as patient diaries, symptoms, adverse events, drug supply management, and scheduling. Last year FDA released a guidance document on electronic informed consent; recently another guidance document on using electronic medical records in clinical trials emphasized the shift towards increasing automation in clinical trials. Read More..


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