news roundup
Atlantic Research Group has formed its rare disease strategic advisory board (SAB). The SAB will consist of outside scientific experts, patient advocates, and former executives from rare disease-focused biotechs.
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8th Clinical Quality Oversight Forum – October 11-13, Philadelphia
Join 150+ senior-level clinical quality, compliance and operations professionals to discuss strategies for ensuring trial integrity by effectively assessing, optimizing and managing the quality of clinical vendors and sites. Featured topics include ICH E6 R2, building a quality culture, inspection readiness, risk-based monitoring and auditing and more.
 Register by August 25 for maximum savings. |
SRD, a CRO in Tokyo, Japan, has selected OmniComm’s TrialMaster electronic data capture technology to support clinical trial research for pharma, medical devices, and related healthcare products.
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Clinical Trial Simulation: An Efficient Tool for Improved Study Designs, Dose Selection and Go/No-go Investment Decisions
Live Webcast: Tuesday, September 19 at 2:00pm BST and Thursday, September 28 at 10am EDT
 Register now |
FDA is encouraging biopharma companies to adopt innovative research methods and drug development tools to reduce the cost and time of bringing new therapies to patients. Similarly, the agency is exhibiting more flexibility in approving cutting-edge therapies that follow less conventional and streamlined R&D programs.
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Articles
Consolidation among contract clinical research services providers during the past five years has been brisk and it has resulted in substantial market share gains among the top 10 largest CROs (e.g., INC Research’s May acquisition of inVentiv Health). Ken Getz examines the implications behind the deals.
The purpose of this review was to compare results from point-of-care diagnostic testing (POCT) and central lab screening to determine whether POCT would have an impact on ruling out subjects who would not successfully pass the higher-cost CL screening process.
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Blog Posts
Dr. Joanne Waldstreicher, Chief Medical Officer of J&Js Office of the Chief Medical Officer (OCMO) discusses its data sharing program with the Yale University Open Data Access (YODA) Project.
Tufts, CluePoints, and PWC organized a roundtable, which included senior executives from top tier pharmaceutical organizations that have responsibility for facilitating the changes required by the new ICH guidance to understand their challenges to achieve a common level of understanding across their organizations.
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