Medical Quality Assurance

In clinical trials, QA focuses on implementing Good Clinical Practice (GCP) standards, ensuring protocol adherence, maintaining data integrity, and protecting patient rights. From designing quality systems to conducting routine audits, QA functions act as a safeguard against errors and helps generate reliable, credible clinical evidence. By embedding QA throughout trial design and execution, sponsors can achieve smoother regulatory approvals and higher confidence in their trial outcomes.

Clinical trial QA must adhere to GCP guidelines, as outlined by the International Council for Harmonisation (ICH), and any local or regional regulations (e.g., FDA’s 21 CFR Parts 50, 54, 56, and 312 in the United States; EU GMP Annex 13; ICH E6 worldwide). These requirements mandate rigorous documentation, investigator oversight, data management protocols, and transparent reporting. ADRES helps sponsors align with these regulations, tailoring QA strategies to meet both local and international expectations.

ADRES offers end-to-end QA consulting tailored to clinical research needs, from initial risk assessments and SOP development to mock inspections and post-trial reviews. Our experts stay updated on evolving global regulations and leverage experience across QA, CMC, and RA to deliver comprehensive solutions. We work closely with sponsors to safeguard data quality, mitigate protocol deviations, and streamline regulatory submissions—ultimately helping bring safe, effective therapies to patients faster.

Sponsors should ideally initiate medical QA activities as early as possible—often before the clinical trial design is finalized or during the initial development of a medical device or pharmaceutical product. Early integration of QA helps: • Prevent Costly Rework: Identifying gaps before trial initiation minimizes the need for expensive corrective measures later. • Ensure Protocol Compliance: Embedding QA in protocol development helps maintain consistency and clear oversight from the outset. • Facilitate Regulatory Alignment: Building QA into early planning ensures alignment with FDA, EMA, ISO, and other regulatory frameworks. • Enhance Patient Safety: A strong QA foundation ensures patient risk is mitigated from the very first steps. At ADRES, we work closely with sponsors in the pre-trial or early development phase to build robust quality systems, based on phase-base approach, establish compliant processes, and conduct risk assessments. By starting QA initiatives early, sponsors gain increased confidence in the clinical data they generate, streamline regulatory submissions, and ultimately deliver safer, more effective therapies to patients.

Data integrity hinges on traceability, accuracy, and completeness of trial information. QA programs implement strict access controls, robust data capture systems, and regular data verification processes. These measures help prevent issues like data tampering or transcription errors. A strong QA framework also includes documented procedures for handling data corrections and maintaining audit trails, ensuring credible, reproducible study results including Data Integrity Agreements which define the responsibility and obligations of the sponsor, the CRO and the clinical site regarding Data Integrity and Source Data Verification.