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Preparing for ICH E6 (R3) Good Clinical Practice Changes, Upcoming Webinar Hosted by Xtalks Share Article In this free webinar, the featured speakers will discuss ICH E6 (R3) revisions to the Good Clinical Practice (GCP) Guideline and how they affect your clinical trials. Learn about Quality Tolerance Limits (QTLs), how they relate to the new guidance, and how they can help you avoid roadblocks in your clinical trials. The presenters will also discuss how to identify Critical to Quality (CtQ) factors and use them to create focused indicators of quality, which will help you prepare your clinical development for upcoming compliance requirements. ....
Medidata: collaboration furthers decentralized trial progress Through organizations like the Association of Clinical Research Organizations, clinical research professionals are helping decentralized research evolve. While decentralized trial technology is rapidly advancing, and adoption of such technology is climbing, many professionals in the field feel a need for standards and consensus. Through a new group within the Association of Clinical Research Organizations (ACRO), leaders in the industry are working toward that goal. Outsourcing-Pharma (OSP) recently discussed the rapid advancements of decentralized trials and the work of the ACRO Decentralized Trials Working Party with Fiona Maini (FM), global compliance and strategy principal for Medidata. ....