Late Phase Medical Writing Services
Effective Medical Writing can support the regulatory success of a product, helping to ensure that scientific content is documented in an accurate, concise, and audience-appropriate format. Our Medical Writing department comprises experienced professionals capable of leading the development of a wide range of regulatory document types in collaboration with functional leads from both the Sponsor and Worldwide team.
Regulatory Documents
Medical Writing services range from the preparation of individual documents through to producing extensive Medical Writing programs (e.g., from protocol synopsis development to clinical trial reports and journal publications). Document preparation is facilitated by a robust set of quality management documents/standard operating procedures, ICH compliant templates and a comprehensive Medical Writing style guide. The Medical Writing team is flexible and can adapt to working with Sponsor templates and style guides, as required, and has the experience to accommodate project-specific needs.
Our standard process involves qc review, Medical Writer peer review, and subject matter expert review of all Draft 1 documents before they are sent to a Sponsor. In addition, all documents go through ha full qc review prior to finalization.
We are a diverse global team, with Medical Writers based across Europe and North America, and all are members of the European Medical Writers Association or the American Medical Writers Association. The Medical Writing team also includes Document Coordination Specialists who support all medical writing and publishing-related activities.
Stand-alone Projects
The Medical Writing team offers customizable stand-alone services to help Sponsors meet company goals or regulatory requirements. These services encompass full regulatory writing projects or partial services like CTR narrative writing, QC review, DSUR, IB updates, and Medical Writing peer review.
Transparency & Disclosure and Plain Language Services
Within the Medical Writing department, we have a dedicated Transparency & Disclosure (T&D) team specializing in redaction and anonymization techniques to support submission activities and offering a wide range of plain language services.
The T&D team creates study-specific personal protected data (PPD) redaction rule tables and consults with Sponsors on commercial confidential information (CCI) identifiers. Fully redacted packages for both Part I and Part II CTIS packages can be provided. The T&D team offers Policy 0070 compliance services including risk assessment, advising on anonymization strategy, preparing a redaction proposal document, and redacting the final CTR to be published as a part of the Marketing Authorization Application in the EU. For GDPR compliance, the T&D team offers redaction of TMF documents to assist Data Controllers in implementing the appropriate technical measures to ensure that personal data are processed following the data protection rules.
In addition, the T&D team oversee plain language services, including writing and/or reviewing plain language summaries (e.g., protocols and clinical trial reports), patient recruitment materials and public health information.
The following represents a curated collection of documents in which the Worldwide Medical Writing Department has played a pivotal role:
Study-related Documents
- Briefing Books
- General Investigation Plans
- Investigator’s Brochures
- IMPDs
- IMPD/IND conversions
- Protocol Synopses
- Protocols and Amendments
- Master ICFs and Amendments
- Assent forms and Amendments
- Protocol clarification letters
- DSURs
- PSURs
- Interim Analysis Reports
- CTRs including Abbreviated Reports and Addenda
- CTR Narratives
- Journal Publications
T&D and Plain Language Services
- Protocol Lay Summaries
- CTIS Part I Package
- CTIS Part II Package
- CTR Lay Summaries
- Manuscript Lay Summaries
- Patient Recruitment Materials
- Public Health Education Materials
- Review of Plain Language Materials
Stand-alone Projects
- Protocols
- CTRs
- CTR Narratives
- Investor Reports
- QC review
- IMPDs
- Manuscripts
CTR = clinical trial report; DSUR = drug safety update report; ICF = informed consent form; IMPD =investigational medicinal product dossier; IND = investigational new drug; PSUR = periodic safety update report; QC = quality control; T&D = transparency and disclosure
