SCIENTIFIC & MEDICAL WRITING
Clinical Study Report (CSR) Writing Service
Accurate, ICH-compliant reporting for your clinical trials.
Meeting regulatory requirements entails precision and a deep understanding of ICH E3 guidelines. We provide expert writing support to deliver high-quality CSRs that are fully consistent with the CSP and Statistical Analysis Plan.
What we can help you with
- Full ICH E3-compliant CSRs
- Abbreviated and Synoptic Reports
How we help you
- Regulatory alignment: We ensure the CSR strictly follows ICH and GCP guidelines, preventing review delays or rejections.
- Data Integration & Accuracy: We synthesize complex data from protocols, SAPs, and TLFs into a coherent narrative without errors or misinterpretations.
- Cross-Functional Leadership: We act as the central anchor for your team, optimizing time and resources to keep the project on schedule.
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 data and documentation required (e.g. CSP, SAP, TFLs, and appendices).
- 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 Quality Control on the final document.