April 2015 – The CenterWatch Monthly : PDF
PSI, INC Research, Chiltern best with sites
Contract research organizations (CROs) have become more effective in managing working relationships with investigative sites during the past two years, according to a new CenterWatch survey, yet the average CRO continues to fall below performance expectations in many of the areas investigators consider most critical for study success. In the 2015 CenterWatch Global Investigative Site Survey, CROs overall received a combined excellent/good rating of 80%, a 2% increase from 2013, and the average CRO improved its performance in several key areas, including working effectively with sponsors and conducting clear study initiation visits and training.
Regulatory compliance an increasing burden on sites
As the biopharmaceutical industry strives to reduce its R&D costs and shorten timelines, it must face the fact that today’s successful drug development plans often require more clinical studies than they did a dozen years ago. Often that translates to more complex clinical trials for investigative sites, requiring prescreening of larger patient pools, more personalized data and time-consuming and complex regulatory compliance. Site noncompliance with Good Clinical Practices (GCP) has been rising; many sites have said the regulatory burden continues to increase as study timelines continue to slip.
Also in this issue:
- Why doctors are crucial to increasing minority populations in clinical research
- Medical outcome trials: data-driven execution ensures success
- Regulatory Update
- Month in Review
- FDA Actions
- Study Lead Opportunities
- New Drugs in the Pipeline