Successful Completion of Our Good Clinical Practice Audit!

We are thrilled to announce that on September 18-19, 2024, our facility successfully completed the audit conducted by the Republic of Turkey Ministry of Health’s Turkish Medicines and Medical Devices Agency (TİTCK) under the Good Clinical Practice (GCP) guidelines!

What is Good Clinical Practice (GCP)?

Good Clinical Practice (GCP) is an internationally recognized quality standard that establishes essential ethical and scientific principles for conducting clinical trials. This framework enhances the reliability of clinical research while ensuring the rights, safety, and well-being of human subjects are protected. GCP also provides standards that guarantee the accuracy and reliability of the data collected during studies.

Key Elements of GCP:

1. Ethical Principles: Clinical trials must adhere to ethical guidelines, including the Declaration of Helsinki, ensuring the protection of human subjects' rights and dignity.
2. Informed Consent: Participants are entitled to clear and comprehensive information about the study, enabling them to make an informed decision about their involvement.
3. Scientific Basis of Research Design: Clinical studies must follow a well-defined and scientifically valid protocol that outlines the study's purpose, scope, methodologies, and timeline.
4. Risk-Benefit Analysis: The potential benefits of the research must outweigh any possible risks to human subjects. Minimizing risks is a priority.
5. Data Integrity and Reliability: All data collected during the research must be accurate, complete, and verifiable, ensuring that results are trustworthy.
6. Confidentiality: Participants' personal information must be kept confidential and used solely for research purposes.
7. Qualified Researchers and Training: Individuals conducting the research must be well- trained and responsible for maintaining GCP compliance throughout the study.

GCP is applicable across various research fields, including clinical drug trials and medical device studies, and is endorsed by international regulatory authorities like the World Health Organization (WHO), U.S. Food and Drug Administration (FDA), and European Medicines Agency (EMA).

Next Steps

Our audit, conducted in accordance with the GCP guidelines issued by TİTCK, has been successfully completed. We are now prepared to accept clinical studies on human blood at our NanoGLP Laboratory once we receive the authorization certificate from the Republic of Turkey Ministry of Health.

Our Services

We specialize in Clinical Bioanalytical services for Bioavailability and Bioequivalence studies, and we are committed to delivering high-quality support for your research needs.

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The Nano-lab Laboratories Group continues to uphold the highest standards in Good Clinical Practice (GCP) and also provides services related to Good Laboratory Practice (GLP).

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