The purpose of clinical trial monitoring is to guarantee that the trial data is accurate, complete and verifiable, as well as in agreement with ethical and scientific norms. The quality of clinical trial monitoring is the basis of efficient execution and the success of each clinical trial depends upon it. Robust monitoring is vital to a clinical trial, both to protect the integrity of scientific data and to yield valid Regulatory data. To ensure that this data adheres to protocols and international guidelines, the need of the hour is for organizations to opt for an expert medical writing partner who is well-versed with audit and monitoring capabilities.
Freyr has highly skilled and innovative clinical monitoring team which displays professionalism and innovative problem-solving skills while monitoring everything from straight forward, 2-way, cross over bioequivalence (BE) bioavailability (BA) study services to large, complex, steady state BA BE studies. Freyr also provides excellent, independent, monitoring and auditing services for both the clinical and bio-analytical phases of the BA BE study through its highly qualified and experienced monitors. Our monitoring services assist in quality control during clinical trials to maintain the integrity of the trial as per specific standards like ICH Good clinical practice (GCP), the United States Food and Drug Administration (USFDA), Europe, Middle East and Africa (EMEA), The National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) regulations and so on. To provide continued clinical monitoring, our experts can also guide in clinical Standard Operation Procedure (SOP) preparation and review. Freyr’s proactive research site approach helps you to access the best sites following a thorough audit of feasibility and analysis of the CRO/study site along with high quality monitoring of sites throughout the trial duration, to ensure compliance to applicable regulations and guidelines. Our audits and solutions are set to deliver data which is generated with integrity, and also to ensure the sponsor Regulatory compliance and approval.
- Clinical monitoring of 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
- Bioequivalence (BE) study services
- Bioavailability (BA) study services
- Clinical SOP preparation and review
- In-depth Regulatory knowledge perfectly integrated with IT capabilities
- Complete understanding of the complex drug development process, including NCEs, generics, biologics and biosimilars
- Vast experience in working across multiple therapeutic areas like oncology, cardiovascular, psychiatry, respiratory, renal, gastrointestinal, etc.
- Defined processes of thorough scientific, medical, editorial and quality control review in‑house prior to the sponsor review