The Role of Quality Assurance in Clinical Trial

Clinical trials have to follow the ethical standards without compromising the quality of the trial results. The quality assurance teams take care of this critical area in clinical research. India has several clinical research companies who are able to deliver quality output to project sponsors by focusing on GCP(Good Clinical Practice) guidelines as per global standards.

Clinical trials are mostly expensive in nature. If there is a project delay or inadequate results emerge due to quality concerns, the project sponsor may have to spend more or lose all of it. That’s why quality assurance in clinical research cannot be overlooked. Quality issues can lead to legal issues or affect patient safety as well.

Incorporate QA in GCP for better clinical trials

GCPensures that the design, conduct, performance, monitoring, auditing, recording, analysis and reporting are managed in a fair manner.

Some of the QA-focussed clinical research good practices followed by CROs for clinical trial projects are:

Quality in Culture

If a culture of quality is imbibed in the project personnel then every project member handling different responsibilities, will keep an eye on the quality parameters. These professionals will work together as a single unit for implementation of quality assurance guidelines and make it easier for QA analysts to deliver higher number of quality trials.

Quality by Design (QbD)

The project sponsor and the Clinical Research Organisation (CRO) should together design the project in such a way that each step of the clinical trial process has a quality check component. There should be enough QA checks to ensure that error don’t go too far unnoticed. Because, the longer it takes to spot an error, higher are the impacts on the safety and efficacy analysis of the clinical trial.

Quality as per regulatory requirements

The clinical trials have to be conducted in accordance with the guidelines set by global and local regulatory authorities at the trial location. The CRO should be aware of all these regulatory limitations and communicate all the challenges in this respect to the sponsor. This is necessary for avoiding any issues in running quality trials once the project is in the implementation stage.

Quality to respect the trial subject

Clinical trials are conducted on subjects who have to meet specific parameters for ensuring their suitability in trial participation. The quality assurance for clinical trials also takes up the responsibility to get protocol compliant subjects for the project. But these subjects have to be treated with utmost respect and should be treated within the limits of ethics.

Quality Audits

In clinical trials, audit teams run audits for protocols, SOPs, ICH/GCP guidelines and other nation-specific guidelines such as EU Clinical Trial Directives, etc. It is the duty of the audit team to run internal audits during the drug development process, review documented trial data, etc.

As part of quality assurance for clinical research, the audit team performs audits right from the initial data collection stage to the final trial report stage. These audits help the project team members to review the entire clinical trial process; rectify issues on time; and improvise the processes for future trials.