Clinical Trial and Consulting Services

Freyr specializes in clinical trial consulting and writing, providing tailored solutions for Health Authority (HA) submissions. With expertise in Regulatory guidelines and diverse therapeutic areas, we ensure precision and efficiency in all stages of clinical trial documentation.

Clinical Trial and Consulting Services - Overview

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

Freyr’s clinical study report writing team offers tailored solutions to meet a variety of needs of medical writing 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 CSRs, clinical overviews (Module 2.5), clinical summaries (module 2.7), and labeling justification documents.

Clinical Trial and Consulting Services

  • 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 with 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 authoring services
  • Preparation and review of clinical overview (module 2.5) and clinical summary/summaries (module 2.7)
  • Pre-IND meeting support and Regulatory support for the pre-submission compilation and review
  • Preparation of labeling justification document
  • 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, 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 high-quality clinical reports

Celebrating Customers Success

 

Medicinal Products

Medical Writing

India

A big thanks to the Freyr team for the support they have provided to us on priority. We really appreciate the extra effort that the Freyr team has put into providing the reports on time. We are looking forward to a continuous business association with Freyr.​

Head of Quality Assurance​

India-based, Leading Pharma Contract Manufacturing Organization​

 

Medicinal Products

Medical Writing

India

A big thanks to Freyr team for the support they have provided to us on priority. We really appreciate the extra effort that the Freyr team has put into providing the reports on time. We are looking forward for a continuous business association with Freyr.

Head of Quality Assurance

 

Medicinal Products

Medical Writing

UK

We are extremely happy to inform you that the BLA was successfully submitted to the FDA. We convey our sincere gratitude to the Freyr team, who worked diligently, tirelessly, and very closely with our Bridgewater and Beijing teams over the past several months to accomplish this monumental feat on time. Freyr’s team went beyond the call of duty to make this BLA submission come true. We truly appreciate Freyr’s flexibility and eagerness to work with us to accomplish aggressive goals. Look forward to your perennial support and our continued relationship and beyond. ​

Global CMC Technical Lead​

China-based, Leading Innovator Pharmaceutical Company​

 

Medicinal Products

Medical Writing

USA

Thank you, Freyr team. I appreciate your professionalism, dedication, and hard work. You’ve gone above and beyond to ensure all deliverables were met ahead of schedule throughout the project and have done a great job managing a challenging group of products. I appreciate your attention to detail and follow-up on the large workload you’ve managed. It’s been a pleasure working with you, and I wish you and your family all the best in the future!​

Director, Global Labeling Management – Labeling Cluster Head Global Product ​ Development, Global Regulatory Affairs

US-based, Multinational Pharmaceutical and Biotechnology Company​

 

Medicinal Products

Medical Writing

Vietnam​

Thank you so much for being a great partner in our Regulatory compliance journey.

As Asian countries move towards having safety assessments as a key requirement, your support has helped us significantly in fulfilling those requirements well ahead of our competitors in Vietnam. ​

In fact, I shared your contact with our regulatory officers so that they can share it across the industry if the safety assessments become necessary.

Lead, R&D/Personal Care

India-based, Multinational Consumer Goods Company​

 

Medicinal Products

Medical Writing

USA

Kudos to you all for the brilliant teamwork !! Alone, we can do so little; together, we can do so much.

Look forward to the next milestone and collaboration on new projects in the future.

SVP - R&D ( Finished Dosage Form)​

US-based, CRO Company that Focuses on Material Science and Engineering for Drug Development​