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 the varied requirements of different regulatory agencies.

Do you have medical writing,  regulatory writing, or medical communications needs?  Let's Talk.  

In the Last 5 Years

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Medical writing projects supported

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INDs and CTAs written

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Marketing Applications/Authorizations Written (NDAs, BLAs, MAAs, etc).

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) 
  • Patient Narratives
  • Safety Narratives 
  • Clinical Development Plans 
  • Investigator Brochure and Patient Information Leaflets 
  • Lay Summaries
  • 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 (IND, CTA, and IMPD)
  • Marketing Applications in eCTD format (NDA/BLS, MAA, NDS, etc.) 
  • Integrated Summaries of Safety & Efficacy (ISS & ISE)
  • Responses to questions from Regulatory Authorities and Agency reviewers 
  • Regulatory Briefing documents for Agency meetings 
  • Special Designation applications, including Orphan Drug Designation Applications (ODDs) and PIP/PSP
  • Risk Management Plans 
  • Individual Case Safety Reports (ICSRs) and Aggregate Reports 
  • Core Value Dossiers

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.   

DOWNLOAD THE CASE STUDY

Veristat_CS_RareCancerstoRegSubmission

 

Scientific and Medical Communications for Thought Leadership 

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, slides and posters for professional meetings 
  • Conference reports
  • Clinical trial registry and results postings on clinicaltrials.gov and EudraCT 
  • White papers, publications, and manuscripts for scientific use
  • Medical education materials 
  • Literature reviews and searches  

Speak with Veristat if you need the right medical and regulatory writers to communicate your successes.

LET'S TALK

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