Overview

The purpose of clinical trial monitoring is to guarantee that the trial data is accurate, complete and verifiable in agreement with ethical and scientific norms. Quality of clinical trial monitoring stands the backbone for efficient execution and the success of each clinical trial. Either to protect the integrity of scientific data or to yield valid Regulatory acceptable clinical data, robust monitoring is vital to a clinical trial. To ensure the data adhere to the protocols and international guidelines, the need of the hour for organizations is to opt for a proven 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 BA BE studies to large complex steady state BA BE studies. Freyr provides excellent independent monitoring and auditing services for clinical and bio-analytical phases of the BA BE study through its highly qualified and experienced monitors. Our monitoring services assist as Quality Control (QC) in clinical trial to maintain the integrity of the trial as per the specific standard like ICH Good Clinical Practice (GCP), United States Food and Drug Administration (USFDA), EMEA, ANVISA regulations etc. Freyr’s proactive research site approach will help you to get the best sites following a thorough audit of feasibility and analysis of the Contract Research Organization (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 will be integrated to deliver the data which is generated with integrity, and also ensures the sponsor Regulatory compliance and approval. 

 

Freyr Expertise

  • Clinical monitoring of phase I trial and bio-equivalence studies
  • Bio-analytical monitoring of phase I trial and bio-equivalence studies
  • Auditing of be CRO/study site
  • System audits of phase I-BE CRO/study site
 

Freyr Advantages

  • In-depth Regulatory knowledge perfectly integrated with IT capabilities
  • Complete understanding of the complex drug development process, including New Chemical Entity (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 QC review in‑house prior to sponsor review
  • Experience in writing documents for various phases of clinical development including Phase I to Phase IV, post-marketing surveillance studies (PMS) and post-authorization safety studies (PASS)
  • Well-versed in working with various stakeholders like clinical operations, data management, biostatistics, medical and safety teams to deliver documents
  • Assured of getting submission ready documents in terms of technical information, language, format and template used to prepare the document.
  • Timely delivery with the highest standard of quality