A clinical study report is not a summary of what happened. It is a regulatory document that will be reviewed by scientists, statisticians, and safety reviewers at EMA, FDA, or national competent authorities. The standard is not 'accurate and well-written.' The standard is 'complete, consistent with the statistical analysis plan and the data, structured to the authority's guidance, and able to stand alone as a regulatory submission document.'

Medical writing at this level requires writers who understand the clinical context, the statistical analysis, and the regulatory framework simultaneously. Writers who receive a completed analysis dataset and produce a document around it are not working at the required standard.

At APICES, medical writers are embedded in the study team from the protocol stage. By the time the final analysis is complete, the CSR structure is already designed, the statistical tables and figures specifications are agreed, and the first shell of the document is drafted. This is how sponsors get from database lock to submission-ready CSR in weeks, not months.

Clinical Study Reports and Regulatory Documents

• Protocol-level writing: clinical protocols, protocol amendments, and protocol synopses
• Investigator's Brochures (IBs) and Investigational Medicinal Product Dossiers (IMPDs)
• Full clinical study reports (CSRs) to ICH E3, including integrated summaries for MAA Module 2.7
• Plain-language summaries (lay summaries) under EU CTR Article 37, including national language adaptation and readability review
• Safety reports: SUSARs, DSURs, PSURs, and aggregate safety summaries
• Regulatory response documents for List of Questions (Day 120), Day 150, and Request for Information cycles

Medical Device Clinical Documentation

For medical device programmes under MDR 2017/745, APICES provides clinical evaluation reports (CERs) and clinical evaluation plans (CEPs) to the standard required by EUDAMED submission and Notified Body review. CERs require not just medical writing proficiency but an understanding of the MedDRA coding, literature search methodology, clinical investigation data integration, and the equivalence arguments that Notified Bodies scrutinise.

IVDR clinical performance study reports and post-market clinical follow-up (PMCF) reports are also within scope, aligned with MDR Article 84 and MDCG 2020-7 requirements.

Publications and RWE Reporting

For real-world evidence and HEOR studies, APICES provides medical writing and reporting aligned with ENCePP Code of Conduct standards, STROBE reporting guidelines, and TREND checklist requirements where applicable. Publication support – manuscript writing, target journal selection, statistical figure preparation, and submission management – is delivered under Good Publication Practice (GPP) standards.

What You Can Expect

• Writers embedded in the study team from protocol stage – not engaged after database lock
• CSRs authored to ICH E3 and specific authority expectations, with prior EMA/FDA submission experience
• EU CTR Article 37 lay summaries including national language adaptation
• Clinical evaluation reports (CERs) and PMCF reports for MDR and IVDR programmes
• Observational study reports to ENCePP and STROBE standards
• Publication support under GPP to peer-reviewed journals
• Standard CSR reviewed over three formal sponsor review rounds with a senior writer present

Frequently Asked Questions

What documents does APICES write?

Protocols, IBs, IMPDs, CSRs, plain-language summaries (lay summaries under EU CTR Article 37), regulatory submissions and modules, MDR clinical evaluation reports (CERs), and peer-reviewed publications.

Do your writers know EMA and FDA expectations?

Yes. Senior medical writers have authored documents accepted by EMA, FDA, MHRA, AEMPS, ANSM, and BfArM. They write for the regulator that matters for your programme, not from a generic template.

Can you write CTIS lay summaries?

Yes. EU CTR Article 37 lay summaries (in the relevant national languages) are part of our medical-writing scope – including the patient-facing translation and readability review.

Do you support publication strategy and journal submission?

Yes. Manuscript writing, target-journal selection, statistical-figure preparation, and submission management – all under Good Publication Practice (GPP) standards.

How do you collaborate with the sponsor on draft cycles?

A typical CSR cycle is three formal sponsor reviews on a tracked-changes Word document, with a senior writer in the room (or on the call) for each review.