Overview

The purpose of clinical trial audit and monitoring is to guarantee that the trial data is accurate, complete, verifiable, and in agreement with the ethical and scientific norms. The quality of clinical trial monitoring is the basis for efficient execution, and the success of each clinical trial depends upon it. Robust clinical trial monitoring is vital, to protect the integrity of the scientific data and yield valid Regulatory data. To ensure that this data adheres to the 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 clinical trial audits and monitoring.

Freyr has a skilled and innovative clinical trial audit and monitoring team which showcases innovative problem-solving talents while monitoring everything from straightforward, 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 and independent clinical trial monitoring and auditing services for both the clinical and bio-analytical phases of the bioequivalence (BE), and bioavailability (BA) studies through its highly qualified and experienced monitors.

Our clinical 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 data monitoring, our experts also guide in preparing and reviewing 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 with the applicable regulations and guidelines.

 

Freyr Expertise

  • Clinical trial monitoring services 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 
 

Freyr Advantages

  • 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 in-house processes for thorough scientific, medical, editorial, and quality control review before the sponsor review