by SOCRA | Jul 22, 2020 | Professional Development, Project Management, Training
By: Anatoly Gorkun, MD, PhD, Chartered MCIPD Senior Manager, Global Clinical Development, PPD UK Abstract: Effective communication skills in clinical research are vitally important. Due to many...
by SOCRA | May 13, 2020 | Clinical Research, clinical research regulations, COVID-19
Defining a “New Normal” in Clinical Research to Support the World’s 336,747 Research Studies By: Jennifer Goldfarb – MSN, RN, CCRP As of April 21, 2020, according to clinicaltrials.gov, there were 336,747 research studies registered by organizations in all 50...
by SOCRA | Mar 29, 2020 | Clinical Research, clinical research regulations, FDA, FDA Drug Approval
U.S. Food and Drug Administration, Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA). As our society becomes more global, it has become increasingly clear that the U.S. Food and Drug Administration needs to take a more...
by SOCRA | May 17, 2019 | Monitoring
By Takoda Roland, CCRA, CCRP Founder of Philadelphia Pharmaceutical Research Disclaimer: The examples noted in the following are all firsthand accounts of the author, but for the purpose of this article have been combined into a single site visit. The visit depicted...
by SOCRA | Oct 23, 2018 | Electronic Data Capture (EDC)
Adam Donat, MS, Martin Hamilton, MSN-FNP, Irfan Khan, MS, Nichole Chamberlain, MSN-FNP Organization: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Division of Bioresearch Monitoring The findings and conclusions in...