What is the Role of Quality Assurance in Clinical Trials?

Posted by Vial on June 2nd, 2021

Quality Assurance is the organized and independent assessment of all clinical trial-associated activities and records. Pharmaceutical companies recognize the benefits of carefully managing data quality from their drug development and clinical trials.

This data also helps academia, industry, and regulators to make crucial decisions about the safety and effectiveness of the disease or preventative medicines being studied. Pharma clinical research project sponsors generally assign critical project responsibilities such as quality assurance to Contract Research Organizations or CROs.

Clinical trials are the most expensive. If a project delay or inadequate results emerge due to quality concerns, the project sponsor may have to spend more or lose all of it.

Let's have a look at the role of quality assurance in a clinical trial:

Quality in Culture:

On the off chance that a culture of quality is imbibed in the undertaking workforce, members handling various responsibilities will keep an eye on the quality parameters. These professionals will cooperate as a single unit to implement quality assurance rules and make it easier for QA analysts to convey a higher number of quality trials.

Quality by Design:

The Clinical Research Organization (CRO) and project sponsor should design together plan the undertaking so that each progression of the clinical trial measure has a quality check part. There ought to be sufficient QA checks to guarantee that blunders don't go too far unseen. Because the more it takes to detect a blunder, the higher are the impacts on the safety and efficacy analysis of the clinical trial.

Quality According To Regulatory Prerequisites:

The clinical trials have to be conducted as per the rules 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 regarding the support. This is necessary for avoiding any issues in running quality trials once the venture is in the implementation stage. 

Quality to Respect the Trial Subject:

Clinical trials are conducted on subjects who have to meet explicit parameters for guaranteeing their suitability in trial participation. The quality assurance for clinical trials also takes up the responsibilities to get protocol compliant subjects for the undertaking. Yet, these subjects have to be treated with the 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, other nation-specific guidelines such as EU Clinical Trial Directives, etc. The audit team must run internal audits during the drug development process, review documented trial data, etc.

As part of quality assurance for innovation in 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.