Overview

After years of successful clinical research, submission of documents for Health Authority (HA) review requires a specialized skill of clear and precise writing. Such clear and precise writing aids reviewers to easily comprehend  the technicalities of clinical research, as even a single error in clinical documentation may prove risky and costly for organizations, causing delays in gaining eventual  approval. In such a scenario, organizations look for a medical writing expert who can handle a wide variety of clinical documentation in quick turnaround times.

Freyr tailors solutions to meet a variety of medical writing needs with respect to clinical trial services starting from strategic services for the conduct of clinical trials till the submission of clinical trial dossier, attending/addressing HA queries and fetching marketing authorization of the medicinal products/devices.

 

Freyr Expertise

  • Protocol writing and expert review of phase I, phase II, phase III & phase IV clinical studies including protocol amendments
  • ICH GCP compliant Clinical Study Report (CSR) writing and review including CSR body and shell, synoptic, abbreviated and full submission reports
  • Topline summary
  • Investigator Brochure (IB) development and expert review
  • Informed Consent Form (ICF) preparation and expert review
  • Preparation of IND application supporting documents
  • Clinical sections of new drug applications (NDAs), Investigational new drug applications (INDAs) and Abbreviated new drug applications (ANDAs)
 

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 processes of thorough scientific, medical, editorial and quality control 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, bio-statistics, medical and safety teams to deliver documents
  • Submission-ready documents in terms of technical information, language, format and template used to prepare the document
  • Timely delivery with highest standard of quality