Currently, industry guidance for quality in clinical development is fragmented across multiple documents from multiple sources. The regulators require improved quality, the inspectors are expecting QMS to be operating effectively. While quality systems exist in other industries such as pharmaceutical manufacturing and aviation, there is no industry-wide conceptual framework for clinical Quality Management that aims to address quality and monitor and improve performance in complex clinical development-specific environments.
Through partnerships with Health Authorities and other industry stakeholders, the Quality Management System (QMS) Initiative has aimed to explore ways to improve quality across the industry.
The benefits of the Quality Management System Initiative include enhanced patient safety by improving quality, assuring data integrity, minimizing delays in clinical trials and bringing drugs to market more quickly.
Benefits for Sponsors:
- Improved image and credibility of medical research through increased commitment to improve patient safety, data reliability, and data integrity
- Greater ability to solve repetitive quality issues which individual companies have been unable to tackle on their own, through collaboration
Benefits for Sites:
- Decreased burden on the sites by streamlining clinical trial processes and focusing on measuring “Issues That Matter”
Benefits for Patients:
- Increased safety during clinical trials
- Fewer study delays through reduced remediation associated with quality issues
- Increased efficiency through reduction of remediation associated with addressing quality issues, ultimately getting drugs to market faster
Benefits for Regulatory Authorities:
- Increased ability for industry to proactively adapt to Regulatory changes
- Provides consistent quality framework for Regulatory Authorities to evaluate and measure “Issues That Matter”
In May 2016, the QMS Initiative developed a Clinical QMS Conceptual Framework Paper published in the DIA journal Therapeutic Innovation and Regulatory Sciences. The Conceptual Framework describes a proactive approach and flexible framework for holistically managing quality across the spectrum of clinical activities. The framework is intended to enable consistent delivery of reliable data that may be used by an organization, its partners, regulators, clinicians, sites and patients to make informed decisions.
Subsequent publications have included topic-specific manuscripts on Issue Management and Clinical Knowledge Management, as well as a tool for sponsors to Assess their Clinical QMS (ACQMS) according the elements laid out in the original paper, and other materials, all available for industry use.
For more information about the QMS Initiative, please click to Initiative Assets to learn more.
Site Qualification and Training (SQT)
The SQT Initiative collaborates with TransCelerate Member Companies, investigator sites, CROs and health authorities to achieve the goal of enhancing and simplifying clinical trial SQT processes and to reduce administrative burden on sites.
Clinical Data Standards
The Clinical Data Standards Initiative, in collaboration with leading industry organizations, aims to develop industry-wide Data Standards in priority Therapeutic Areas (TAs) to support the exchange and submission of clinical research and meta-data, while improving patient safety and outcomes.
Risk Based Monitoring
TransCelerate’s Risk Based Monitoring initiative seeks to develop an model approach for risk-based monitoring of clinical trials, with the goal to both enhance patient safety and ensure the quality of clinical data.