Christine Senn headshot

On the Job: Lessons Learned from Opening New Research Sites

Clinical Researcher—February 2018 (Volume 32, Issue 2) Christine Senn, PhD, CCRC, CPI, ACRP-CP, FACRP [DOI: 10.14524/CR-18-4008] Quality research sites make the clinical research enterprise work. Without research sites, there is no proof-of-concept possible after the years of research and development (R&D) done by the amazing biochemists and bioengineers that precede launching a clinical trial. Where […]

ICH in Focus: ICH GCP E6(R2): Requirements and Challenges for Clinical Trial Sites

Clinical Researcher—February 2018 (Volume 32, Issue 2) Sara Spadoni, PhD [DOI: 10.14524/CR-18-4009] The changes brought by the International Council for Harmonization’s (ICH) E6(R2) addendum to its Guideline for Good Clinical Practice (GCP) and the subsequent adoption by the European Medicines Agency effective June 14, 2017, have had a significant impact on sponsors, contract research organizations […]

WCG: The Digital Pill

SPECIAL ADVERTISING SUPPLEMENT Ten years ago, the smartphone united two existing technologies—the telephone and Internet—to revolutionize global communication. Today, we are experiencing a revolution in healthcare, with powerful medicine and innovative technology coming together to transform the way we treat patients and manage diseases. On November 13, 2017 the United States Food and Drug Administration […]

Clinical Project Managers Stuck Betwixt and Between

Clinical Researcher—February 2018 (Volume 32, Issue 2) PEER REVIEWED Andy Mehrotra [DOI: 10.14524/CR-17-0036] Why today’s project leads need to evolve their role as part of strategic contract research organizations It’s no secret that contract research organizations (CROs) are playing a larger role in supporting the clinical trial process today than even just five years ago. […]