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Two people discussing and signing documents related to audits in clinical trials of medicinal products and medical devices. The discussion focuses on compliance with the valid law and guidelines concerning Good Clinical Practice (GCP). Audits are a crucial element of the quality assurance system that each Sponsor of a clinical trial must manage. SciencePharma’s team of qualified auditors, with extensive knowledge in clinical trials, conducts independent assessments at every stage of a project or study. Services include conducting systemic audits, verifying standard operating procedures, assessing potential vendors, processes or contracting activities, and audits associated with clinical trials during or after completion. To improve quality, appropriate preventive or corrective actions are proposed.

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.

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