Global Standards of Quality Assurance in Clinical Trials

Clinical trials are conducted to collect relevant data for discovery of new drugs for curing or prevention of diseases. 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. Clinical research project sponsors generally assign critical project responsibilities such as quality assurance to Contract Research Organizations or CROs.

Need for Quality Assurance (QA) in clinical trials

Quality assurance in clinical trials ensures that globally-accepted Good Clinical Practice (GCP) standards are followed to conduct the trials in a fair manner and high-quality data is collected.

CROs help project sponsors with the design of the protocol; project monitoring, report evaluation and project documentation to be sent to the regulatory authorities for approval. The clinical research data has to be good enough for verification during audits and inspection by regulatory organisations.

The regulations are stringent for clinical research. India has some of the most trusted clinical research services offering superior quality assurance in clinical trials. For product approvals, the regulatory authorities have to be convinced that the clinical trials were conducted while protecting the safety and rights of the human subjects who were part of the trial.

Following are the leading global standards of quality assurance in clinical trials:

ICH

ICH has created an extensive range of safety guidelines. Clinical operation services follow these guidelines which were put forward to discover possible risks such as reprotoxicity, carcinogenicity and genotoxicity during trials.

FDA

FDA stands for Food and Drug Administration. It is one of the leading regulatory authorities that regulate scientific research focussed on new findings to develop new drugs. The aim of investigators who conduct these studies is to find out if the drugs being investigated are safe to use and can effectively solve the research problem. FDA ensures that confidentiality and safety is maintained in these clinical research studies

CFR

The CFR or Code of Federal Regulations by FDA needs to be followed by clinical research services to adhere to the compliance standards for drug development. The CFR codes are part of the Food, Drug, and Cosmetic Act for ethical production of safer products for end users.

ISO

International Standards Organization or ISO is an authority that has set global standards for various industries and is followed by majority of nations across the world. For quality assurance in clinical trials, ISO 14155:2011 standard is followed today. The ISO certification is given to newly developed drugs that clear the ISO assessment. These assessments are conducted based on the national regulations and the nature of the clinical trial.

WHO

World Health Organization (WHO) has put forth GCP guidelines for various countries across the world. The content in these guidelines may vary from country to country but the pre-requisites for most countries remain the same. The purpose of these guidelines is again to establish scientific integrity and ethics in clinical research with human subjects.

Biosphere CRO offers clinical research services by experts who are well-versed with the industry standards for quality assurance in clinical trials. To discuss quality assurance services by Biosphere, contact 022-41006794 or visit biospherecro.com to learn more.