Overview

After years of successful clinical research, submission of documents for Health Authority (HA) review requires a specialized skill of clear and precise clinical report writing. Such clear and precise clinical 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, compilation and review of pre-submission package, attending/addressing HA queries, and fetching marketing authorization of the medicinal products/devices. Our team of professionals can also help in preparation of high-level reports like Clinical Study Reports (CSRs), preparation and review of clinical overview (Module 2.5), clinical summary/summaries (module 2.7) and Labeling justification document.

 

Freyr Expertise

  • Protocol writing and expert review of phase I, phase II, phase III & phase IV clinical studies including protocol amendments
  • Regulatory CSR writing and review compliant with ICH GCP guidelines including CSR body and shell, synoptic, abbreviated and full submission reports
  • Preparation and review of Topline Summary (TLS) for CSR
  • 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), Abbreviated New Drug Applications (ANDAs), New Drug Submissions (NDS) and Abbreviated New Drug Submissions (ANDS)
  • Regulatory dossier writing services
  • Preparation and review of clinical overview (module 2.5) and clinical summary/summaries (module 2.7)
  • Pre-IND meeting support
  • Regulatory support for compilation and review of pre-submission package
  • Preparation of labeling justification document
 

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 inhouse 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