ClinPlus Weekly Wrap

1. FDA offers ‘encouraging’ draft guidance for adaptive device trials, expert says  Adaptive clinical trial designs can be used in medical device studies as long as they are for “prospectively planned modifications based on accumulating study data without undermining the trial’s integrity and validity,” the FDA says.    2. Expert says participation in adult cancer clinical trials […]

ClinPlus Weekly Wrap

Clinical trial transparency, a new bill, and PharmaSUG in our ClinPlus Weekly Wrap! 1. Study: Clinical trial transparency improving  An ABPI study shows that transparency is improving and has a very high rate in larger phase III trials. 2. What 21st Century Cures will mean for clinical trial sponsors  This article gives a complete description about […]

ClinPlus Report and CDISC ADaM

DZS Software Solutions, Inc. will be showcasing ClinPlus Report (CPR), the most powerful table and listing authoring and template library management software available, at the PharmaSUG conference in Orlando Florida, May 17-20.  CPR is designed as a productivity tool used to create and manage standard table and listing templates and non-standard templates as well.    A […]

Clinplus Weekly Wrap

We are wrapping up this week with articles about clinical trial efficiency, women in clinical trials and possible new FDA laws. 1. FDA’s Woodcock calls to cut clinical costs via new efficiencies  As the cost of clinical trials continues to grow, Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA told Senators earlier […]