Clinical Researcher—June 2019 (Volume 33, Issue 6) PEER REVIEWED Seema Garg, MS, MBA, CQA, CSSGB Most of the time when someone in charge at a research site first brings up their desire for a quality management system (QMS), the first thought that comes to many staff members’ minds is “Oh no! We have to […]
Clinical Researcher—June 2019 (Volume 33, Issue 6) PEER REVIEWED Mary Kay Kessinger Sobcinski, RN, BSN, MHA; Susan Wiskow, CCRP The U.S. Food and Drug Administration’s (FDA’s) Bioresearch Monitoring (BIMO) program is designed to protect the rights, safety, and welfare of subjects, verify the accuracy and reliability of clinical study data, and assess study compliance […]
Clinical Researcher—June 2019 (Volume 33, Issue 6) DATA-TECH CONNECT Richard Young According to Tufts Center for the Study of Drug Development (CSDD), the average time to build and release a clinical study database is more than 73 days and the average time to lock data at the end of a trial is nearly 39 […]
Clinical Researcher—June 2019 (Volume 33, Issue 6) RECRUITMENT & RETENTION C. Meghann Howland; T.J. Bowen, PhD Oncology researchers face a sizable patient recruitment challenge. The numbers alone paint a revealing picture: roughly 14,000 oncology trials are actively recruiting,{1} garnering participation rates estimated at a mere 3% to 8% of possible candidates, with even more […]
Clinical Researcher—June 2019 (Volume 33, Issue 6) CRO CLOSEUP Julie Ross The life sciences industry is experiencing tremendous innovation, bringing drugs to market at an accelerated pace. In 2018, the industry achieved a record-setting number of 59 drug approvals.{1} These new drugs offer tremendous hope, but the costs to develop new and complex therapies […]
