Sponsor-Site Communication in Device Trials: Evolution of a Dedicated Field Clinical Organization Throughout Study Execution

Clinical Researcher—September 2018 (Volume 32, Issue 8) PEER REVIEWED Jennifer Krueger, MACPR; Carolynn Jones, DNP, MSPH, RN; Marjorie Neidecker, PhD, MEng, RN, CCRP Successful study execution is essential for sponsors and physician investigators. A quality study ensures timely collection of study data to ensure accurate measures of safety and efficacy. This impacts current patients and, […]

The Use of a Blended Simulation Model to Increase the Confidence of Non-Clinical Personnel in Performing Clinical Tasks

Clinical Researcher—September 2018 (Volume 32, Issue 8) PEER REVIEWED Erin Prettiman, MSN, RN, ACNS-BC; Donamarie N-Wilfong, DNP, RN; Therese Justus McAtee, DNP, RN, CEN, TNCC; Laura Daniel, PhD   Vital signs, electrocardiograms (ECGs), and phlebotomy tasks have critical importance as the primary means to detect changes in patient condition and effectiveness of therapies. With such […]

For Principal Investigators, the One-and-Done Syndrome Persists

Clinical Researcher—September 2018 (Volume 32, Issue 8) SPECIAL FEATURE Ann Neuer, MBA Leon Rosenberg, a self-proclaimed physician-scientist at Princeton University and the former president of the Pharmaceutical Research Institute at Bristol-Myers Squibb Company, wrote a fascinating piece in The Journal of Clinical Investigation about the declining number of clinical investigators.{1} He declared, “In the absence […]

Industry Taking Action to Unify Clinical Operations

Clinical Researcher—September 2018 (Volume 32, Issue 8) CLIN OPS INSIGHTS Jim Reilly, MBA New life sciences industry research reveals there has been significant momentum toward streamlining clinical systems and processes over the past year. More than 300 clinical operations professionals from around the globe were surveyed for the Veeva 2018 Unified Clinical Operations Survey, which […]

Madeleine Kennedy headshot

Further Processing of Personal Data in Clinical Research

Clinical Researcher—September 2018 (Volume 32, Issue 8) ICH IN FOCUS Madeleine Kennedy While informed consent is a prerequisite for the enrollment of subjects in a clinical trial (according to the tenets of the International Council for Harmonization [ICH] Guideline for Good Clinical Practice E6(R2) 4.8), the General Data Protection Regulation (GDPR)* imposes a number of […]