We have decades of experience ensuring compliance with stringent regulations and certifications in clinical research, setting benchmarks for all our Good Clinical Practice audits and services.
Compliance with ethical standards is crucial in Good Clinical Practice (GCP) audits, ensuring research involving human subjects upholds the highest ethics. It includes participant recruitment with informed consent, transparently informing them of the study’s purpose, risks, & benefits.
Protecting the confidentiality of participants’ personal data is essential, safeguarding their privacy throughout the study. Additionally, the audit ensures the protection of participants’ rights, treating them with respect & dignity.
It verifies that research protocols undergo rigorous review by institutional review boards, validating the scientific merit & ethical soundness of the study’s design & conduct. Monitoring & adverse event reporting ensure safety & data integrity.
Regulatory adherence in GCP audits ensures clinical trials comply with laws and guidelines by verifying documentation, protocol adherence, ethical approvals, and data integrity.
Atvigilx specializes in Pharmacovigilance, Regulatory Affairs, and GCP Services, providing comprehensive support to ensure compliance…