Right now, there is no harmonized regulatory guidance defining elements of a Clinical QMS framework. This has led to organizations struggling to implement the ISO 9000 principles, as well as the fragmented guidance that do exist and created significant inefficiencies.
Poor quality can result in:
- Increased Health Authority time and resources and uncertainty in review
- Increased Sponsor time, energy, effort and resources in terms of re-work
- Delays to delivering new medicines to patients with unmet medical needs and a poor image of the industry
Through partnerships with Health Authorities and other industry stakeholders, the Quality Management System (QMS) Initiative aims 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.
The initial resource the QMS Initiative is developing is a Clinical QMS Conceptual Framework Concept Paper. The Conceptual Framework will describe 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, and patients to make informed decisions.
For more information about the QMS Initiative, click here to access our overview of this initiative.
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.