GCP
In accordance with the valid law and guidelines concerning Good Clinical Practice (GCP), audits in clinical trials of medicinal products, as well as medical devices, constitute an essential element of quality assurance system, that each Sponsor of a clinical trial must take care of.
SciencePharma possesses a qualified team of auditors, who have a broad knowledge in the terms of clinical trials. The acquired experience enables us to an independent assessment on each stage of a development project/study.
We offer e.g., conduct of systemic audits, during which we verify the standard operating procedures and other quality documents, an assessment of potential vendors, processes or contracting activities, audits associated with a clinical trial, during its conduct or after its completion, as well. In order to improve the quality, we can propose introducing appropriate preventive or correction actions.