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 base of efficient execution and the success of each clinical trial depends upon it. Robust monitoring is vital for 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 for organizations is to opt for an expert medical writing partner who is well-versed with audit and monitoring.
Freyr has highly skilled and innovative clinical trial audit and monitoring team which showcases innovative problem-solving skills while monitoring everything from straight forward, 2-way, cross over bioequivalence (BE) and bioavailability (BA) study services to large, complex, steady state bioequivalence (BE) and bioavailability (BA) study services. Freyr also provides excellent, independent, monitoring and auditing services for both the clinical and bio-analytical phases of the bioequivalence (BE) and bioavailability (BA) 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 also guide in preparation and review of clinical Standard Operation Procedure (SOP). 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 throughout the trial duration, to ensure compliance to applicable regulations and guidelines.
- 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
- Preparation and review of Clinical SOP
- 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