Medical Writing Services
Providing clear, structured, and compliant clinical and regulatory documentation.
Integrated Writing Solutions
Our medical writing support combines scientific interpretation, structured authoring, document control and cross‑functional review to produce clear clinical and regulatory documents. Globyz Clinical Solutions provides this service under an integrated affiliate framework with CEBIS USA LLC, its U.S. affiliate and clinical research arm, through a coordinated delivery model. Clinical studies are conducted within this integrated affiliate framework.
Global Standards
FDA · EMA · ICH Guidelines
Scientific Rigor
Accuracy & Compliance
Writing Excellence
Clear, compliant clinical & regulatory documents
Our Core Services
Precision writing across every document type, therapeutic area, and regulatory jurisdiction.
Regulatory Medical Writing
- Clinical Trial Documents: Protocols, CSRs, IBs, and ICFs
- Submissions: IND/CTA, NDA/BLA, eCTD modules, DSURs, PSURs
- FDA/EMA Compliance: Adherence to ICH guidelines
Scientific Communications
- Manuscripts, abstracts, posters, and lay summaries for journals and conferences
- Medical education and marketing content for HCPs and payers
Therapeutic Expertise
- Specializations: Oncology, Rare Diseases, Neurology, Cardiovascular, Medical Devices
- RWE: Post‑market surveillance and benefit‑risk assessments
Technology-Driven Solutions
- AI-Powered Tools: Automated literature reviews, NLP-based drafting, and eCTD formatting
- Decentralized Trials (DCT): Remote monitoring and telehealth integration
Global Reach
- Multilingual writers supporting trials in North America, EU, Asia-Pacific, and emerging markets.
- Local expertise applied across all critical regions.
Documents We Support
Assignments may cover a single document or a coordinated set of documents across a clinical program.
Assignment-Based
Scope confirmed per project
Study synopses, protocols, and protocol amendments
Investigator brochures and supporting summaries
Informed consent and participant-facing materials
Clinical study reports and report appendices
Safety and aggregate documents where included in scope
Regulatory briefing materials, responses, and clinical summaries
A Controlled Authoring Process
We begin with an agreed outline, source list, author and reviewer roles, style requirements, schedule, and approval pathway. Drafts are reconciled against source data and cross‑functional comments, with version control and decision tracking maintained throughout the document lifecycle.
Agreed Outline & Source List
Document scope, reference materials, and applicable templates confirmed upfront.
Author & Reviewer Assignment
Roles, responsibilities, and approval pathway defined before drafting begins.
Drafting & Source Reconciliation
Drafts aligned against source data, statistical outputs, and study records.
Version Control & Decision Log
Comments tracked, reconciled, and archived throughout the document lifecycle.
Integrated Review
Writers coordinate with clinical, regulatory, data, statistics, safety, quality, and subject matter experts so that terminology, endpoints, analysis descriptions, and conclusions remain aligned.
Clinical
Regulatory
Data
Statistics
Safety
Quality
Subject matter experts are engaged to ensure terminology, endpoints, analysis descriptions, and conclusions are scientifically and regulatorily aligned at every draft stage.
Start a Medical Writing Assignment
Share the document type, source materials, applicable template, target audience, review team, and deadline. We will confirm assumptions, milestones, and the responsible lead.