Change Management in Clinical Trial Operations: Putting People Before Process

Clinical Researcher—May 2018 (Volume 32, Issue 5) SPECIAL FEATURE Matthew Harrington [DOI: 10.14524/CR-18-4027]   Imagine if a career staff member of your local hospital was told by management to prioritize high-risk patients and check on others later—or not at all. For many clinical research professionals, this is an unsettling yet familiar scenario. They face a […]

Expectations of Cell Therapy: An Evaluation of the Cardiovascular Cell Therapy Research Network PACE Trial

Clinical Researcher—May 2018 (Volume 32, Issue 5) PEER REVIEWED Shelly L. Sayre, MPH; Judy Bettencourt, MPH; Michelle Cohen, MPH; Rachel W. Vojvodic, MPH; Emerson C. Perin, MD, PhD; Phillip C. Yang, MD; Michael P. Murphy, MD; Doris A. Taylor, PhD; Patricia G’Sell, RN; Eileen Handberg, PhD; Lem Moyé, MD, PhD [DOI: 10.14524/CR-17-0041] [Editor’s Note: Tables […]

Behind the Scenes of Clinical Trials

Clinical Researcher—May 2018 (Volume 32, Issue 5) MANAGING EDITOR’S MESSAGE Gary W. Cramer [DOI: 10.14524/CR-18-4030]     Having acted in more than a few community theater productions in my life, I am a big proponent of the idea that what goes on “behind the scenes” is every bit as important—if not more so—than what the […]

Improving Clinical Research Trials: Best Practice Do’s and Don’ts for Managing Business Operations

Clinical Researcher—May 2018 (Volume 32, Issue 5) GOOD MANAGEMENT PRACTICE Ted Finlan, PMP, CSM [DOI: 10.14524/CR-18-4026]   Time is critical for public and private sponsors of clinical research. As clinical trials take on increasing complexity, clinical research organizations (CROs) must be able to help manage operational data and optimize timelines to support their sponsors’ submission […]

Medical Device and Diagnostics Clinical Investigations—A Sea-Change in Route to Market

Clinical Researcher—May 2018 (Volume 32, Issue 5) DEVICES TODAY Adam Steadman [DOI: 10.14524/CR-18-4028]   The approach to the global development of medical devices is going through a sea-change. The global market for medical devices is growing at tremendous rates, particularly in the Asia-Pacific region, and not only in historic sectors such as cardiovascular and orthopedics, […]