Clinical Trial Audit and Monitoring Services - Overview
Clinical trial audits and clinical trial monitoring guarantee that the trial data is accurate, complete, verifiable, and in agreement with ethical and scientific norms. Clinical trial monitoring quality is the basis for efficient execution, and the success of each clinical trial depends on it. Robust clinical trial monitoring is vital to protect the integrity of the scientific data and yield valid Regulatory data. To ensure that clinical data adhere to the protocols and international guidelines, organizations must opt for clinical trial audits and monitoring services that can well-manage intricacies of bioavailability and bioequivalence studies.
Freyr’s clinical trial audit and monitoring services consist of a skilled team that showcases innovative problem-solving talents while monitoring everything from straightforward, 2-way, cross-over Bioequivalence (BE) and Bioavailability (BA) studies services to large, complex, steady-state BE and BA study services. Freyr also provides independent clinical trial monitoring and auditing services for clinical and bio-analytical phases of the BE and BA studies through its highly qualified and experienced clinical monitoring team.
Our clinical trial audit and monitoring services assist in quality control to maintain the integrity of the clinical trial per standards set by ICH Good Clinical Practice (GCP), the United States Food and Drug Administration (US FDA), Europe, Middle East, and Africa (EMEA), the National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) regulations, etc.
To provide continued clinical trial monitoring, our clinical experts guide in preparing and reviewing clinical Standard Operation Procedures (SOPs). Freyr’s proactive research-site approach helps you access the best sites following a thorough audit of feasibility and analysis of the CRO/study site, along with high-quality monitoring throughout the trial duration, to ensure compliance with the applicable regulations and guidelines.
Clinical Trial Audit and Monitoring Services
- Clinical trial monitoring services for phase I trial and bioequivalence studies.
- Bio-analytical monitoring of phase I trial and bioequivalence studies.
- Auditing of BE CRO/study site.
- System audits of phase I-BE CRO/study site.
- BA/ BE study services.
- Preparation and review of clinical SOP.
- In-depth clinical trial audit and monitoring knowledge perfectly integrated with IT capabilities.
- Complete understanding of the complex drug development process, including NCEs, generics, biologics, and biosimilars that facilitate clinical monitoring.
- Vast experience in dealing with clinical trial audit imperatives across multiple therapeutic areas like oncology, cardiovascular, psychiatry, respiratory, renal, gastrointestinal, etc.
- Defined in-house processes for clinical trial monitoring to provide thorough scientific, medical, editorial, and quality control reviews before the sponsor review.
