Getting the Future We Deserve

Clinical Researcher—August 2019 (Volume 33, Issue 7) EXECUTIVE DIRECTOR’S MESSAGE Jim Kremidas   From the Philip K. Dick novel-turned-miniseries The Man in the High Castle to Philip Roth’s novel (and soon-to-be miniseries) The Plot Against America, alternate history in science fiction and fantasy can be thought-provoking as it contrasts our real world against an artist’s […]

Don’t Judge a Site by its Cover

Clinical Researcher—August 2019 (Volume 33, Issue 7) CRA PATHWAY Elizabeth Weeks-Rowe, LVN, CCRA   As children growing up, we are taught to never judge a book by its cover, but to look within for the true character of a person. As researchers, we are taught to gather and analyze data before forming our ultimate hypotheses. […]

BIMO Inspections: Recommendations for Sponsors

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 […]