MEDICAL AND SCIENTIFIC WRITING
MEDICAL AND SCIENTIFIC WRITING
Key Services
Aligning scientific insight with regulatory standards
Our medical writing team translates scientific knowledge into clear, compliant documentation that supports the development, approval, and post-marketing phases of drugs and medical devices.
Clinical Trial Documentation
Our team can support with a wide range of essential clinical documents preparation (e.g study protocols, amendments, study reports), lay summaries and other needed support (e.g consulting and plans preparation for the 510k pre-submission)
Aligning scientific insight with regulatory standards
Our medical writing team translates scientific knowledge into clear, compliant documentation that supports the development, approval, and post-marketing phases of drugs and medical devices.
Clinical Trial Documentation
Our team can support with a wide range of essential clinical documents preparation (e.g study protocols, amendments, study reports), lay summaries and other needed support (e.g consulting and plans preparation for the 510k pre-submission)
Great experience
Our medical writing team have supported clients with different services and therefore been involved in more than 50 trials in more than 15 indications!
Trusted partner
With 4 in-house Medical Writers, the GCPS team will make sure you get the support you need for your study.
Efficient and accurate
Need 4 weeks for a study protocol, 6 weeks for the report and lay summary, and just 1 week for the ICF? No problem, our team delivers with precision and speed!
Collective Experience
15+ years of combined experience in medical writing for clinical research.
Medical Writing Support for Clinical Research Success
Clear, compliant documentation is essential to clinical research. At GCP-Service, our expert medical writers support every stage of your trial, protocols, reports, publications, and regulatory submissions.
With strong knowledge of ICH-GCP, EU, and FDA standards, we ensure your documents are accurate, submission-ready, and tailored to your audience.
Trust our CRO expertise to keep your trial documentation on track and inspection-ready.
We provide end-to-end regulatory medical writing services, including:
- Clinical Study Protocols (CSPs) and Protocol Amendments
- Investigator’s Brochures (IBs)
- Clinical Study Reports (CSRs)
- Informed Consent Forms (ICFs)
- Common Technical Document (CTD) modules (especially Modules 2.4, 2.5, 2.6 and 2.7)
- Clinical Evaluation
We can bridge the gap where you need. In medical writing, one size never fits all. Each document demands a tailored approach because precision, context, and audience matter. The Informed Consent Forms must speak the patient’s language, ethics committees pay close attention to that. And when it comes to protocols, every project is different: whether it’s a medical device or an investigational medicinal product, a registry, an observational plan, or a 510(k) synopsis, each comes with its own focus and challenges. That’s where our expertise makes the difference.
MEET OUR SERVICE LEAD
Gayane Buhr (Team Lead Medical Affairs)
Gayane began her career in clinical research as a product safety officer, also becoming one of the first medical writers within GCPS. Having participated in over 70 clinical trials involving various indications and products, Gayane focused on patient safety and conveying information to patients and the study team. Writing is not only about conveying information; it is also about storytelling and planting ideas in the reader’s mind to help them understand the message.
MEET OUR SERVICE LEAD
Gayane Buhr (Team Lead Medical Affairs)
Gayane began her career in clinical research as a product safety officer, also becoming one of the first medical writers within GCPS. Having participated in over 70 clinical trials involving various indications and products, Gayane focused on patient safety and conveying information to patients and the study team. Writing is not only about conveying information; it is also about storytelling and planting ideas in the reader’s mind to help them understand the message.
Our Experts Are Ready to Support Your Trial
Connect with our team for expert medical and scientific writing that supports your clinical research success.
Related services
Clinical research requires a coordinated approach across multiple disciplines. Explore our complementary services to support your project at every stage.