SCIENTIFIC & MEDICAL WRITING.
Clinical Study Protocol (CSP) Writing Service
Building a solid foundation for your clinical research.
A weak protocol is the leading cause of trial delays. We help you writing robust, ethically sound, and scientifically rigorous protocols.
What we can help you with
- Protocol drafting.
- Revision
- Quality check
How we help you
- Regulatory compliance: We ensure alignment with GCP and regulatory standards before the trial begins
- Scientific rigor and clarity: We prevent misunderstandings that can compromise data integrity.
- Operational feasibility: We guarantee that objectives, endpoints, and the schedule of assessments link together logically.
Our team on your project
Our scientific and medical writing team includes 9 experienced writers and editors, all of whom have a solid research trajectory, mostly in biomedical and clinical research.
For every project, we assign a team of two experienced professionals, with distinct roles:
- An experienced medical writer to lead content development
- A project manager to oversee deadlines and to double-check the precision of every deliverable
Our workflow
We have developed a modular pipeline that adapts to your project according to how much support you need.
- Opening meeting: We schedule an exploratory call/meeting with you to discuss the project and your support needs.
- Data transfer: You share with us all information required (e.g., your internal template if it applies, study overview, synopsis, table of assessments, IBs and SmPcs, and crucial references).
- First draft and questions + your feedback and answers: We build a first draft, pose questions for you to resolve, and you send us your answers and feedback.
- Full draft + your feedback: We develop a full draft based on your initial feedback and answers, and you send us your final feedback.
- Reviewing and Quality Control: We review and incorporate your feedback and perform a Quality Control on the final document.