Cystic Fibrosis Clinical Research Coordinator Mentoring Program: A Review

Clinical Researcher—November 2019 (Volume 33, Issue 9) PEER REVIEWED Zoe Davies, NP, MS, CCRC; Colleen Dunn, MS, RRT, CCRC; Elizabeth Hartigan, MPH, RN, CRM; Kathleen Hilliard, CCRC; Patricia Burks, RN, MA, CCRC   Cystic fibrosis (CF) is an inherited, autosomal recessive, multisystem disease that affects approximately 30,000 individuals in the United States{1} and is caused […]

Evaluating the Role of the Regulatory Writer

Clinical Researcher—November 2019 (Volume 33, Issue 9) PEER REVIEWED Ridge Archer, MACPR; Mary Raber Johnson, PhD, RAC; Esther Chipps, PhD, RN, NEA-BC   Drug development is a billion-dollar industry featuring a variety of roles necessary to pursue the goal of product approval.{1} A crucial component within this process is well-developed, well-documented, and well-communicated study research […]

Three Biopharmas Speed Trials by Modernizing Clinical Data Management

Clinical Researcher—November 2019 (Volume 33, Issue 9) DATA-TECH CONNECT Henry Levy   Clinical teams are under enormous pressure to reduce cycle times and accelerate trials to completion. It costs an estimated $2.6 billion to get a drug to market{1}—twice as much now compared to 15 years ago. Study delays can contribute $800,000 to $8 million […]

Hiring, Upskilling, and Retaining Quality Talent for Clinical Trials

Clinical Researcher—November 2019 (Volume 33, Issue 9) GOOD MANAGEMENT PRACTICE Rocco Raffo; Taylor Crook   The U.S. life sciences sector in 2019 continues to be a leading driver of significant economic gains for the country, representing 2.1 million jobs across 82,300 companies last year. Buoyed by strong spending on research and development, the rise of […]