Clinical and Medical Affairs
Medical Writing.
Clinical documentation that meets regulatory requirements: precise, structured, and compliant with regulatory standards. We prepare Clinical Study Reports, Investigator Brochures, study protocols, and Safety Reports in accordance with ICH, EMA, and FDA standards.
What challenges arise in clinical documentation?
The preparation of clinical documents is always extremely time-sensitive and strictly regulated:
- Clinical Study Reports (CSRs) must strictly comply with the ICH E3 guideline—formal errors can delay costly regulatory approvals.
- Investigator Brochures (IBs) are often outdated in terms of content and do not reflect the current status of the development program.
- Study protocols are often written without genuine writing expertise, leading to time-consuming amendments later on.
- A lack of internal capacity regularly leads to significant bottlenecks just before important deadlines.
Do you have all the necessary clinical documents for your next critical regulatory submission—complete and up to date?
Our medical writing services.
We draft clinical documents that convince regulatory authorities and significantly expedite complex approval processes.
Clinical Study Reports (CSR)
Complete preparation of the CSR in accordance with the strict ICH E3 standard. Seamless integration of biometric data, clinical patient narratives, and complex safety data. We also handle the review and final quality assurance for existing CSRs.
Study Protocols & Protocol Amendments
Development of clinically robust study protocols for all phases of clinical trials. Clear formulation of hypotheses, primary endpoints, study design, and the statistical plan in language that complies with regulatory requirements—including the management of unavoidable amendments.
Investigator's Brochure & DSUR
Complete preparation and reliable annual updating of investigator brochures in accordance with ICH E6. Preparation of the Annual DSUR (Development Safety Update Report) for ongoing and complex clinical programs.
Periodic Safety Reports (PSUR / PBRER)
Timely preparation of Periodic Benefit-Risk Evaluation Reports in accordance with ICH E2C(R2). Professional integration of field data, clinical results, and global spontaneous reports into a coherent safety assessment.
Frequently Asked Questions About Medical Writing.
What is a Clinical Study Report (CSR) according to ICH E3?
A CSR is the complete and binding final report of a clinical trial in accordance with the ICH E3 guideline. It documents the study design, methods used, detailed results, and medical conclusions in a globally standardized format. The CSR is an essential component of NDA, BLA, and MAA submissions.
What does a medical writer do, and what does a technical writer do?
Medical writing focuses on purely clinical documents: clinical study reports, investigator brochures, study protocols, and PSURs. Technical writing, on the other hand, covers technical product documentation: instructions for use (IFU), technical dossiers, and SOPs. Both require in-depth regulatory expertise but operate in different areas of the life sciences.
How long does it take to prepare a clinical study report?
The typical turnaround time is between 8 and 16 weeks, starting from the handover of the final biometrics outputs. The exact timeline depends heavily on the desired level of detail in the documentation, the number of study sites involved, the complexity of the clinical endpoints, and the number of review cycles required with your sponsor team.
Is medical writing also useful for investigator-sponsored trials (ISTs)?
Yes, definitely. Even valuable actual results must be documented in a thoroughly professional manner if they are to be used later for regulatory submissions or publication in high-impact peer-reviewed journals. Clean, well-structured clinical documentation significantly increases the chances of publication and acceptance.
Additional expertise in clinical documentation and regulatory affairs.
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