Services

Medical Writing

Quality medical writing of clinical trial documents, safety updates, and marketing applications for regulatory success

Medical writers are critical to the communication process of outlining the goals, strategies, analysis, and medical understanding of a clinical trial/program to patients, sites, sponsors, and regulatory agencies. Our scientific-minded writing team has significant experience preparing clinical documents including protocols, clinical study reports (CSRs), and Investigator’s Brochures.

Veristat excels in writing regulatory documents to support drug, biologic, device, and diagnostic marketing applications to regulatory agencies worldwide. We understand the complexities of writing in a highly regulated environment and the challenges of varied requirements of different regulatory agencies.

Medical Writing for Clinical Trials & Marketing Applications

Veristat provides medical writing support for the full life-cycle of a product’s development, beginning with early-stage development through marketing application and post-approval. We offer rapid turnaround to meet tight timelines, and flexible, efficient processes for any project large or small. Using in-house or sponsor-supplied document templates, we apply best practices for content, format, and style to meet global technical and regulatory requirements. Our expert medical writing team supports the development of the following types of documentation:

Clinical Trial & Program Documentation

Protocol Synopsis, Protocols, and Amendments
Informed Consent Forms
Clinical Study Reports (CSRs)
Safety Narratives
Clinical Development Plans
Investigator Brochure and Patient Information Leaflets
Annual reports
- Periodic safety update reports (PSURs)
- Development safety update reports (DSURs)
- Periodic benefit-risk evaluation reports (PBRERs)

Regulatory Submission Documents

Marketing Applications in eCTD format (including IND, CTA, NDA/sNDA, MAA, NDS, jNDA)

Clinical & Non-Clinical Summaries (Module 2)
Integrated Summaries of Efficacy and Safety (Module 5)
Responses to Agency reviewers
Regulatory Briefing documents for Agency meetings, including:
- Pre-IND, End of Phase 1, End of Phase 2/3, Pre-NDA and Advisory Committee
Orphan Drug Designation Applications
Risk Management Plans

Medical Writing Support for Thought Leadership

Additionally, our medical writers offer medical writing support to share clinical trial data and results in many formats including:

Slide presentations for industry conferences and regulatory agency meetings
Abstracts & posters for professional meetings
Clinical trial product registration and results postings on clinicaltrials.gov and EudraCT
White papers, publications, and manuscripts
Literature reviews and searches
Style guide creation