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 Trial and Regulatory Submission Documentation

Veristat provides medical writing support for the entire life cycle of a product’s development, beginning with early-stage development through regulatory registration and commercialization. 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:

Writing for Clinical Trial Documents

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)

Writing for Regulatory Submission Documents

Clinical Trial Applications in eCTD format (including INDs, CTA and IMPD)
Marketing Applications in eCTD format (including NDA/sNDA, MAA, NDS, jNDA, etc.)
Responses to Regulatory Authorities and Agency reviewers
Regulatory Briefing documents for Agency meetings
Special Designation applications, including Orphan Drug Designation Applications (ODDs)
Risk Management Plans
Individual Case Safety Reports (ICSRs) and Aggregate Reports

A Collaborative Medical Writing partnership to Advance Rare Cancer Therapy to FDA Approval

Read the case study to learn how Veristat medical writers supported a sponsor from writing the IND to writing the NDA for a product now approved by FDA.

Communicating the successes and updates of your product to many stakeholders in the development journey is critical. Veristat medical writers, regulatory writers, and Pharmacovigilance experts offer writing support to communicate clinical trial results and safety data across formats including:

Style guide creation
Presentations for Investors, business meetings, 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 for scientific use
Literature reviews and searches