From preclinical reporting through the drug development life cycle to post-marketing and commercialization writing, we deliver world-class medical writing skills across a broad range of therapeutic areas and document formats.
Our writers create documents for a variety of audiences using data from various sources and analytic models, manage writing projects, and maintain consistency of style and message across multiple documents. They have effective work management and negotiation abilities, and they work on projects with a diverse customer base and external thought leaders.
They manage timetables, organise and coordinate authorship meetings, and reconcile sponsor feedback across departments in order to produce consistent, scientifically cohesive materials with minimal customer supervision.
We offer flexible solutions for partnering with customers’ in-house writers to take on specific standalone document-related tasks, providing cost-effective solutions that remove the burden of routine medical writing tasks and allow our customers’ writers to focus on content development, in addition to providing writing services for complete deliverables.
In a functional service partnership approach, all of our solutions can be supplied as part of full-service programmes or as independent solutions.
We have great experience in developing functional service provider relationships (FSPs), offering collaborative and strategic solutions that provide layers of additional benefit to our customers, in addition to providing support on an individual clinical trial or project basis.
Services For individual studies, we provide regulatory writing services:
Regulatory Writing Across Studies
Aggregate Safety Reports (study or program level):
Publication Writing (study or program level):
Medical Editing:
- Formatting and editing regulatory and publication documents using the appropriate style guide and templates.
- Reviewing writings for grammar, spelling, and style to improve readability and prevent errors.
- Providing quality assessment services by comparing source data to document content to ensure accuracy and consistency.
- Composing publications for submission to a new venue.
- Ensure that regulatory documents are submission-ready and compliant with electronic common technical document standards by completing primary publication.
Specialized Services:
- Clinical trial registry records support
- Medical information letters
- Document redaction
- Advisory committee slide creation
- Regulatory submission bibliographies
- Regulatory document finalization and publishing
- Lay language documents
- Submission support
- Clinical trial transparency and disclosure
- Document project management
