In order to present related information to a clinical study and acquire and document informed consent, electronic systems and processes such as text, audio, and graphics are increasingly being employed. According to FDA per their new draft guidance, this is referred...
Conducting clinical research is extremely time consuming given the extensive requirements necessary to begin a clinical trial. Protocols must be adhered to, results must be extensively recorded, and most importantly, patients must be protected complying with Section...
The US Institute of Medicine (IoM) has recently released a report supporting the movement for full transparency in clinical trial information saying, “releasing information is in the public interest and maximizes the contributions made by clinical trial participants...
Fred Upton, chairman of the House Energy and Commerce Committee, and Rep. Diana DeGette have recently launched the 21st Century Cures initiative, a bill intended to improve clinical trials and expedite the drug and device approval process. Upton and Degette plan to...
Last month at Partnerships in Clinical Trials (PCT) in Barcelona, Spain, TransCelerate Biopharma CEO, Dalvir Gill explained to contract research and pharma industry representatives that working together to fix issues is the key to simplifying and expediting the...
The National Institutes of Health’s (NIH) National Institute for Allergy and Infectious Diseases (NIAID) launched a new website, ClinRegs, designed to provide country-specific information on clinical trial regulations. The website contains a number of resources to...
