news roundup
The European Commission, FDA and EMA have signed a new confidentiality agreement that allows regulators on both sides of the Atlantic to share non-public and commercially confidential information, including trade secrets about inspections.
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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.
 CLICK HERE FOR MORE INFORMATION AND TO REGISTER. |
Allscripts has partnered with Elligo Health Research to assist clinicians using its EHR platform to access potential patients for clinical trial studies and conduct them in their own clinics.
Parexel and Osaka International Cancer Institute have formed a partnership to advance clinical development in Japan. Together, they aim to drive efficiencies in support of patient recruitment for clinical trials in oncology and hematology, and to develop new cancer treatments for patients.
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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
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Articles
The authors from CDER explain how the FDA is working to adopt electronic practices in its work by initiating efforts to simplify the submission process for new drug and generic drug applications.
Jeff Trotter, president of Continuum Clinical, discusses the company's partnership with online medical community provider Skipta to launch the Center for Observational Research, and recruit physicians for observational studies.
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Blog Posts
This article delves into some elements of an ICF for studies that incorporate mHealth as a supplement to existing study activities (and where a main ICF containing FDA-required ICF elements already exists).
This article discusses best practices and benefits of keeping a trial top of mind at global sites, and measuring some of the qualitative and quantitative impacts it can have on a trial.
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