Clinical and Regulatory Medical
CEBIS supports clinical development programs with medical writing services for study documents, regulatory materials, study reporting and scientific communications.
Writing activities can be coordinated with clinical operations, regulatory affairs, data management, biostatistics and safety teams so documents remain aligned with the study and development program.
Documents Supporting the Study from
Study Planning
Develop and coordinate documents required to define how the study will be conducted.
Study Reporting
Work with clinical, data and statistical teams to develop final study documentation.
Study Start-Up
Prepare participant-facing and investigator-facing materials needed before study activity begins.
Scientific Communication
Support publication-oriented materials where study results are being communicated externally.
Active Study Conduct
Support updates or amendments to clinical documents where study requirements change.
Clear Documents for
Study Protocols
Develop or support clinical protocols that describe the objectives, design and conduct of the study.
Investigator Brochures
Support preparation and maintenance of Investigator Brochures containing relevant product and clinical information for investigators.
Informed Consent Forms
Develop clear participant-facing consent documentation aligned with study requirements.
Case Report Form Content
Support development of the clinical content required for CRFs or eCRFs in coordination with Data Management.
Study Amendments & Updates
Revise affected clinical documents when approved changes occur during development.
Bringing Study Results Into a Clear Final Report
Medical writers can work with:
- Project Management
- Clinical Operations
- Data Management
- Biostatistics
- Pharmacokinetic teams where applicable
- Medical and safety reviewers
Writing Connected to Regulatory Requirements
Clinical and regulatory writing often overlap.
Regulatory submissions may require information produced across clinical, scientific and operational teams to be assembled into consistent documentation.
CEBIS can coordinate medical writing with Regulatory Affairs for materials such as:
- Clinical trial documentation
- Study protocols
- Investigator Brochures
- Informed Consent Forms
- Clinical reports
- Submission-supporting clinical content
- Document revisions and updates
Communicating
Article Development
Support preparation of scientific manuscripts based on available study results.
Abstract Preparation
Poster Content & Design Support
Organize study findings into conference-oriented poster materials.
Journal Adaptation
Align manuscripts with the formatting and submission requirements of the selected journal.
Publication Follow-Up
Support document updates and follow-up through the publication process where included in scope.
Writing Informed by the Teams Behind the Study
Clinical documents frequently require input from several functional specialists.
Medical writing can be coordinated with:
- Clinical Development
- Regulatory Affairs
- Project Management
- Data Management
- Biostatistics
- Pharmacovigilance
- Medical Monitoring
- Quality Oversight
Need Medical Writing Support?
Tell us about your product, development stage, study and required documents. A member of the CEBIS team can discuss the appropriate writing and review support.