Clinical trial monitoring ensures that the trial data is accurate, complete and verifiable, as well as in agreement with ethical and scientific norms. 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 risk-based monitoring team, which assists sponsors in both the clinical and bio-analytical phases of the bioequivalence studies (BE) and bioavailability (BA) studies. Our monitoring services assist in quality control during clinical trials to maintain the integrity of the trial as per the specific standards across the globe. To provide continued clinical monitoring, our experts also guide in the preparation and review of clinical Standard Operation Procedure (SOP).
- 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 the clinical SOP