Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
Strategies and innovations related to how clinical professionals are utilizing technology internal and external to their organizations to advance clinical trials. Go→
News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
The Certified Clinical Research Associate (CCRA) designation is now formally recognized by TransCelerate Biopharma, Inc. (www.transceleratebiopharmainc.com) as evidence of Good Clinical Practice (GCP) training.
Clinical research professionals who hold a current CCRA designation may use that designation as evidence of GCP training while working at any of TransCelerate's 19 member companies, freeing them from any potential obligatory and/or redundant GCP training.
TransCelerate member companies include some of the world's largest pharmaceutical and biotechnology companies with research and development (R&D) operations, including Johnson & Johnson, AstraZeneca, Pfizer, Roche, GlaxoSmithKline, and more. TransCelerate launched in 2012 "to advance innovation in R&D, identify and solve common R&D challenges, and further improve patient safety."
"The CCRA designation shows both my employer and the sites I monitor that I have taken the extra step to be a professional," says Kathryn Kimmel, CCRA, CCRC, Senior Clinical Research Associate at PAREXEL International. "The CCRA designation states I have not only GCP training, but know International Conference on Harmonization and all standards that are needed for good clinical research to be performed at the site level and within my company. It establishes me as someone who has demonstrated the ability to apply this knowledge."
Recognition of the CCRA designation follows TransCelerate's January 2014 recognition of the Certified Clinical Research Coordinator (CCRC) and Certified Physician Investigator (CPI) designations as evidence of GCP training. In February 2014, TransCelerate also recognized ACRP GCP training courses as evidence of required GCP training.