Many research and development (R&D) organizations across the industry have limited access to a quality department in the early stages of development. It’s imperative for organizations to be agile and flexible during each development stage and often organizations interpret quality management systems and quality functions as imposing too much rigidity which may hinder this fast-paced development.

Performing R&D activities well enables researchers to gain the most knowledge in the least amount of time. This also allows an organization to easily move through development stages while efficiently delivering the investigational drug product. By performing good science in an efficient manner, organizations are matching the definition of quality.

What is quality?

Achieving customer satisfaction and meeting requirements are the key principles of quality. Implementing quality early in the discovery phases supports the development and evolves the subsequent development stages. In the pre-clinical development stage, we find more guidance and regulations. Developmental success then leads to the onset of the clinical program and applied good clinical practice (GCP), for which expanding regulatory documentation is referenced. With the onset of investigational drug product manufacturing for any kind of development study, the need for good manufacturing (GMP) arises.

Established quality principles allow for well-supported processes and a culture embracing procedural aspects. This also fosters an understanding of effectively driving activities forward, rather than policing or limiting them.

The challenge of implementing a Clinical Trial Quality Management Plan

Like many aspects of research, organizations may face challenges, especially for growing companies. Quality management system support connects company development and product development.

As a company’s organizational development grows, they will see an increase in activities, staff members, functions, and the need for developed processes. This is usually a linear growth pattern. Conversely, a product’s development path can occur in different stages and is not so linear – product development can jump back and forth or leave the organization at different stages, requiring a great amount of flexibility.

Implementing a Clinical Trial Quality Management Plan that is the right size

Whether an organization is growing or has recently merged, it’s imperative to strengthen their processes through a systematic approach with the foundation of quality. This can be done by effectively implementing a QMS tailored to meet the organization’s needs and supporting the adoption of this approach. A staged approach to building a QMS sets a strong foundation, allowing for growth to support the investigational product’s development phases.


The pharmaceutical industry continually relies on quality in all research activities. Because of this, it’s important to make quality a foundational element of a company, ranging from operations to culture, to organizational functionality.

When looking for a partner to assist with your quality management system assessment or development, it’s important to find one who will collaborate with your organization to develop a tailored, fit-for-purpose approach that does not over-burden your company. The strategy should include assessing and developing curated, regulatory compliant documents, focusing on important, critical-to-quality issues and implementation to ensure compliance.

Additionally, finding the expertise to support the development program, internal teams, and elevate the organizational understanding of critical quality indicators will also give your organization the advantage it needs to improve and enhance quality operations.