Quality Management System

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. As of January 2021, the Quality Management System Initiative is completed. There are no new solutions or updates planned.


Currently, industry guidance for quality in clinical development is fragmented across multiple documents from multiple sources. 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.


  • Decreased burden by streamlining clinical trial processes and focusing on measuring “Issues That Matter”

Regulatory Authorities:

  • Provides consistent quality framework for Regulatory Authorities to evaluate and measure these issues


  • Increased Patient safety during clinical trials


  • Fewer study delays through reduced remediation associated with quality issues, ultimately getting drugs to market faster
  • Greater ability to solve repetitive quality issues which individual companies have been unable to address

Available Solutions

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 Solutions to learn more.

Related Initiatives

Site Qualification and Training

The Site Qualification and Training or '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

Clinical data are reported by individual trials in various ways which may cause a labor intensive process to gain data insights. The Clinical Data Standards Initiative, in collaboration with CDISC (Clinical Data Interchange Standards Consortium), C-Path (Critical Path Institute), NCI- EVS (National Cancer Institute – Enterprise Vocabulary Service) and FDA as part of the CFAST (Coalition For Accelerating Standards and Therapies), aims to develop industry-wide Data Standards in priority Therapeutic Areas (TAs) to support the exchange and submission of clinical research and metadata, while improving patient safety and clinical trial outcomes.

Risk Based Monitoring

The Risk Based Monitoring Initiative was established in 2012 as one of the five initial goals created by TransCelerate to drive efficient and effective solutions into the R&D industry. Clinical trial sites have varying levels of experience and quality, but monitoring approaches are not designed to manage potential differences.