Timely manner meaning trial#Our shared objective is to enable innovation, elevate quality and bring key stakeholders in the clinical trial process into greater alignment. The WCG Metrics Champion Consortium(MCC) is part of the WCG Avoca Quality Consortium, an alliance of industry organizations through which sponsors, CROs and vendors collaborate in a progressive, pre-competitive environment. These quality improvements represent significant opportunities to reframe and rethink how we bring drugs to market, ultimately offering new hope to patients awaiting medical breakthroughs. New insights will help our industry focus not on doing more things but on doing the right things to ensure impactful quality-without overburdening sites or sponsors. This three-part series will share lessons learned along the journey to help stakeholders get ahead of the curve for QTL adoption. Although early adopters have collaborated to understand and apply QTL-related practices, most clinical studies employing QTLs have not yet passed through regulatory inspection-leaving much room for discovery of and reflection on emerging best practices. While quality tolerance limits (QTLs) are standard in some industries, the International Conference on Harmonization’s ICH E6 (R2) 1 represents the first time QTLs have been introduced for application in good clinical practice (GCP). Today’s regulatory updates are driving innovation to revolutionize quality improvement in clinical research.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |