Clinical Trial and Consulting Services - Overview

Submission of documents post clinical research for Health Authority (HA) review requires specialized skill in clinical report writing. Clear and precise clinical report writing helps reviewers comprehend the technicalities of clinical research, as a single error in clinical documentation may prove risky and costly for organizations, causing delays in approval. In such a scenario, organizations look for clinical trial and consulting services & a clinical writing expert who can handle a variety of clinical trial documentation in quick turnaround times. 

Freyr’s clinical report writing team offers tailored solutions to meet a variety of medical writing needs for clinical trials, starting from strategic services for the conduct of clinical trials to the submission of clinical trial dossier, compilation & review of pre-submission package, attending/addressing HA queries, and fetching marketing authorization. Our clinical study report writing team leverages its skills to prepare high-level reports like Clinical Study Reports (CSRs), clinical overviews (Module 2.5), clinical summary/summaries (module 2.7), and labeling justification documents.

 

Clinical Trial and Consulting Services - Freyr Expertise

  • Protocol writing and expert review of phase I, phase II, phase III, & phase IV clinical studies, including protocol amendments.
  • Regulatory Clinical Study Report (CSR) writing and review compliant wit
  • h ICH GCP guidelines, including CSR body and shell, synoptic, abbreviated, and 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 the compilation and review of the pre-submission package.
  • Preparation of labeling justification document.
 

Clinical Trial and Consulting Services - Freyr Advantages

  • In-depth clinical trial consulting knowledge in the Regulatory arena coupled with IT capabilities.
  • Complete understanding of the complex drug development process, including NCEs, generics, biologics, and biosimilars.
  • Vast experience in clinical study report writing across multiple therapeutic areas like oncology, cardiovascular, psychiatry, respiratory, renal, gastrointestinal, etc.
  • Clinical trial consulting for thorough scientific, medical, editorial, and quality control review before the 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.
  • Submission-ready documents regarding technical information, language, format, and templates used to prepare the documents.
  • Timely delivery of clinical reports with the highest standard of quality.