Quality Management System Solutions


Foundational Aspects of Clinical QMS

To develop an effective and efficient clinical QMS, the organization should evaluate and understand the external and internal environment in which it operates. This evaluation will permit tailored development, refinement, and implementation of an organization's clinical QMS based on the unique aspects of the organization.
Leadership commitment can be demonstrated in a variety of ways, including serving as a visible quality advocate, assuming adequate, trained staff are available to support all functions with a role in ensuring clinical quality, and rewarding proactive mitigation of risks to quality.
The organization should cultivate an environment in which each individual takes ownership of quality in his/her role and holds him/herself and others accountable for quality. The organization should recognize individuals or functions by highlighting activities that demonstrate a commitment to clinical quality.
Continual evaluation and improvement of the framework (as tailored and adopted by a particular company) ensures that the framework will be responsive to change and able to meet evolving customer requirements for clinical quality.

For more details on the elements of a Clinical QMS Framework, please review our paper, TransCelerate’s Clinical Quality Management System: From a Vision to a Conceptual Framework. To download all of TransCelerate’s solutions regarding Quality Tolerance Limits, please visit its solutions page.

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

What is a Clinical Quality Management System (QMS)?

A clinical Quality Management System (cQMS) provides an integrated and flexible system through which organizations can systematically plan and achieve quality objectives linked to their broader strategic goals; in the context of clinical research, it can help organizations better manage and navigate the complex clinical trial environment, and expedite drug development and delivery.


Elements of a Clinical QMS Conceptual Framework


Processes should be well defined and characterized prior to determining what requires supporting procedural documentation and what does not. Clear and concise procedural documents (e.g., policies, standard operating procedures, work instructions) should be developed as necessary to ensure consistency in process execution. Where processes cut across multiple functions, development of procedural documents may be best accomplished through cross-disciplinary teams. Leadership commitment to quality should also be reflected through review and approval of procedural documents by appropriate levels of leadership.


Organizations should identify the appropriate level and detail of procedural documentation needed to support clinical development. Procedural documents should be fit for purpose, and should facilitate individuals in readily identifying their roles and associated responsibilities, as well as the context of their roles within the broader process.


Procedural documentation should primarily address changes in the underlying process and evolving customer requirements, or mitigate risks to quality objectives.

Value in cQMS Implementation

Value of a Clinical QMS Framework Infographic


Description: Infographic highlighting examples where Member Companies found significant value implementing a Clinical QMS framework for clinical research.


Value: Implementation examples for five elements of the Clinical QMS framework (Process Management, Risk Management, Partnering, Issue Management and Management Review) highlights where TransCelerate Member Companies have found significant implementation value to help support the delivery of treatments to patients and ensure human subject protection and reliability of trial results.


View Infographic

Resources, Roles & Responsibilities

The organization should prospectively evaluate the required resources and skillsets for achieving its clinical strategy. The organization’s leadership should ensure that appropriate resources are available, including both material resources (systems, standards, training environments) and staff. For staff members, leaders should ensure there is clarity in roles, responsibilities and accountability for operational effectiveness and quality at all levels throughout the organization. Leaders across the organizations should proactively manage resources by anticipating resource and expertise needs according to the strategic direction of the organization, its evolving risk profile and the evolving regulatory environment.


In the clinical development setting, partnerships include both collaborations through which organizations jointly develop a product (e.g., co-development agreements), as well as outsourcing activities (e.g., data management or clinical monitoring). Important to partnering is forging successful strategic relationships.


The organization should prospectively consider the needs, expectations and limitations of all parties involved in a partnership as well as the risks posed by the activities to be carried out in such partnerships. Parties should be transparent about known risks posed by the activities carried out in the partnership, and should agree upon an appropriate strategy for proactively identifying, assessing and addressing risks throughout the partnership.

Risk Management

Risk management is a process through which risks are identified and characterized to permit timely and data-driven decisions about whether and how they need to be addressed. Care should be taken to distinguish between issues (events that have occurred) and risks (potential events with a range of potential consequences). Focusing on risks and their management allows organizations to shift to a proactive and predictive state, prioritizing resources to address the most significant strategic, operational, quality and compliance-related risks


Risk management enables an organization to achieve both organizational and quality objectives by taking explicit account of uncertainty about achieving these objectives, and making informed decisions about how to best manage that uncertainty. Ideally, risk management should be integrated into day-to-day decision making throughout the organization.

Issue Management

An effective issue management framework will improve identification, investigation/assessment, escalation and communication of significant issues – or Issues that Matter. Issues that Matter materially impact patient safety, rights and well-being; data integrity and/or scientific rigor; compliance with regulatory requirements; and trust in the clinical research enterprise.


The issue management framework will provide end-to-end management of issues and support an effective Corrective and Preventive Actions (CAPA) process commensurate with the impact of the issue; it will also enhance risk management strategies and drive continuous improvement through predictive analytics. A successful issue management framework can enable significant issues to not recur, help drugs get to patients faster, reduce resource requirements in drug development and overall, contribute to improving the quality of clinical studies.

Knowledge Management

A knowledge management framework enables the effective and successful implementation of a Clinical QMS. The goal of managing knowledge is to improve organizational performance by getting the right information to the right people at the right time. Loss of knowledge or the failure to apply knowledge may have negative consequences for organizations and most importantly, for patients. A knowledge management framework includes strategies and processes designed to identify, capture, structure, value, leverage and share the organization’s intellectual assets to enhance the clinical development organization’s performance, and the performance of QMS elements such as issue and risk management.


Implementing a structured approach to knowledge management within clinical development can accelerate the delivery of new medicines to patients by increasing productivity through enabling employees to apply knowledge faster; achieving and improving quality and compliance through best practices and lessons learned; and enhancing the ability to maintain and sustain institutional knowledge so that it can be shared and applied at an organizational level.

Documentation Supporting Achievement of Quality

The level of documentation for any clinical development–related process should be commensurate with the risks and significance of the activity in achieving quality objectives and meeting stakeholder requirements. How, where, and for what period of time documentation will be retained should be established prospectively.

Clinical QMS Concept Paper

Name Description Value
Clinical QMS Concept Paper Vision and Outline

DIA TIRS publication which describes the vision and outline for a Clinical QMS conceptual framework.

(published July 2015)

Provides an initial outline of a conceptual framework for a Clinical QMS, and how it can help organizations achieve clinical quality goals linked to their broader strategic goals. Explains how a Clinical QMS alleviates issues related to trial inefficiencies.

Clinical QMS Concept Paper: From Vision to Conceptual Framework

DIA TIRS publication which describes a proposed Clinical QMS framework and reviews feedback from stakeholders.

(published July 2016)

Chronicles the evolution of a TransCelerate paper on the conceptual Clinical QMS framework, and helps readers understand global clinical trial stakeholder perspective.


For a translated version, click here.

Fundamentals of a cQMS

Slides providing concise descriptions and details on each of the foundational aspects and elements of the proposed QMS conceptual framework.

Guides users in understanding the value proposition and potential applications of the QMS conceptual framework elements.

cQMS Overview

Infographic describing R&D challenges faced by organizations in the context of quality, and the benefits of a Clinical QMS in addressing these challenges.

Provides an accessible overview of the QMS conceptual framework and its value.

Clinical & GMP QMS: Complementary Systems Each Fit for Purpose

This infographic explains the differences between a GMP QMS and a GCP QMS.

Provides background on QMS in the context of fit for product manufacturing; conveys why a manufacturing (GMP) and a Clinical QMS must differ.

Perspectives on a cQMS

Video vignettes from different stakeholders in the clinical trial enterprise describing their perspective on the benefits of a Clinical QMS.

Helps users understand stakeholder perspective on the conceptual framework, and its impact on their organizations and the clinical development enterprise at large.


A DIA podcast on the QMS Initiative’s journey from vision to conceptual framework.

Delivers expert discussion of TransCelerate’s QMS, exploring the purpose, evolution and feedback received on the conceptual framework.

Issues Management

Name Description Value
Issue Management Manuscript

DIA TIRS publication which describes a framework for effective issue management within clinical development.

(published July 2016)

Assists clinical development organizations in understanding the benefits and basic components of an issue management system.


For a translated version, click here.

Strategy for Issue Escalation

An overview of the strategy for issue escalation.

A communication plan and decision tree help users understand how to navigate issue escalation.

Conceptual Proactive Triage Thresholds for Potential Issues That Matter

This tool includes slides with a narrative voiceover provided by an expert from the QMS Initiative.

This module covers points to consider, along with scenarios, to assist sponsors in establishing an issue triage mechanism that assesses the impact of an issue.

Enables users to differentiate between Issues That Matter, which are managed through a robust CAPA process, and issues that will be managed according to an organization’s tolerance to risk (thresholds); provides guidance on determining triage thresholds.

Root Cause Investigation / CAPA Plan

This set of tools includes slides with a narrative voiceover provided by an expert from the QMS Initiative.

This module outlines methodologies and points to consider in determining when to use Fishbone, Gilbert Tools, Structured Brainstorming Tools, or Process Mapping. Includes tools on investigations as well as investigative questions.

This series of slides with narrative voiceovers includes the following separate modules:

  1. CAPA Plan Development Tools
  2. Effectiveness Checks
  3. Case Studies
  4. Root Cause Investigation Tools
  5. 5 Whys
  6. Structured Brainstorming
  7. Fishbone Tool
  8. Fishbone with Gilbert Behavior Engineering Model (BEM)
  9. BEM Interview Guide Example
  10. SMARTS Guiding Principles
  11. Effectiveness Check Tools

Provides detail and points to consider for a sponsor when determining an approach for corrective and preventive checks. Includes scenarios that illustrate actions that could be taken to contain or stop the effect of an Issue that Matters, as well as scenarios of both corrective and preventative effectiveness checks.

Analysis and Visualization of Trending and Analytics Data

This tool includes slides with a narrative voiceover provided by an expert from the QMS Initiative.

This module explores activities focused on utilizing data (Issues that Matter and Issues from Thresholds) to aid in identifying trends. Categorization into “buckets” to assess tracking and trending of issues differentiated by thresholds.

Trending and Analytics tools will include characteristics of tools, visualizations of possible metrics that can be produced, scenarios to show the benefits of what a visualization of tools can provide in terms of insights, and predictions and actionable recommendations.

Clinical Knowledge Management

Name Description Value
Clinical Knowledge Management (CKM) Manuscript

DIA TIRS publication which describes a framework for effective knowledge management within clinical development.

(published September 2016)

Assists clinical development organizations in understanding the benefits and basic components of CKM.

CKM High Level Overview

Overview slides that introduce CKM to senior leadership.

Succinctly describes CKM and its potential value, allowing for simple conversation on the topic.

CKM Detailed Overview

More detailed slide deck than the overview slides listed above.

Explores in more detail the intricacies of the CKM concepts explained in the CKM manuscript.

CKM Scenarios

Anonymized scenarios/examples in which a CKM could have, or did help, to address specific issues.

Providers readers with examples of the value (realized and potential) of CKM.

CKM Assessment Tool

A set of survey questions on CKM.

Allows organizations to assess their initial current state of Clinical KM awareness and needs; intended for organizations at early stages in their KM journeys (baseline).

CKM Reference and Tool Guide

Comprehensive list of suggested resources/tools.

Supports the voluntary implementation of KM programming.

Assessing a Clinical QMS

Name Description Value
Assessing a Clinical QMS Tool

A set of survey questions and additional considerations on how an organization may begin to assess the state of their own clinical QMS in alignment with the TransCelerate conceptual model or may also be customized by company to align to their implemented model.

Allows organizations to assess the initial current state of their Clinical QMS in alignment with the TransCelerate conceptual model; may also be used as a periodic assessment tool to allow organizations to focus on improvement in specific areas they deem high priority.

Risk Management

Name Description Value
Risk Management Manuscript

DIA TIRS publication which describes a framework for effective risk management within clinical development.
(published January 2019)

Assists clinical development organizations in understanding the benefits and basic components of risk management specifically for clinical development.

QMS Risk Management Risk Library

A document intended to assist clinical organizations in development of a risk library framework, including grouping risk statements into manageable categories. Describes an example of a specific valid risk, and follows the risk through each step of the Risk Management Methodology.

Facilitates clinical organizations in their development of a risk library, the basis of a clinical risk assessment process and a component of a clinical risk management program. Provides readers with examples of a risk from a risk library, across the various QMS elements.

Risk Management Example

A brief document intended to demonstrate how the methodology works for a single risk that might be in a risk library.

Provides readers with an example of a single risk as it moves through the Risk Management methodology (identification through reporting).


Name Description Value
Processes Manuscript

DIA TIRS publication which describes a framework for effective processes management within clinical development.
(published January 2019)

Assists clinical development organizations in understanding the benefits and basic components of process management for clinical development.

Toolkit for Implementing Processes

A document that describes detailed examples for a clinical development organization implementing a processes framework, identifying how the processes should be documented based on their assessed risks, and how a learning management plan can support the clinical development organization implement the processes and documentation requirements.

Facilitates the implementation of a processes framework for clinical organizations. The toolkit identifies select steps from the processes development framework that would benefit from further instruction, examples, and templates to ensure consistent and robust application of the concepts described in the paper.

QMS Processes Scenarios

This scenario tool uses examples to illustrate how an effective Process Management Framework can ensure the efficient and effective delivery of clinical development programs.

Each scenario is presented in four parts:  the Scenario description, its business impact, possible Process Management Solutions, potential Process Management Benefits to help readers understand the real and potential benefits to a robust process management program.