Clinical Study Report (CSR) Writing Services
Meet regulatory expectations with clear, compliant AI-powered CSRs.
A well-prepared Clinical Study Report is crucial for moving your trial towards regulatory approval, internal decision-making, or public disclosure. At QInscribe, we help your turn complex clinical data into submission-ready CSRs that meet the highest standards, without burdening your internal teams.
Due to our AI-powered process we can handle writing large volumes of CSRs at scale and with industry leading competitive costs. Whether you’re working with an in-house template or need support from draft to submission, we ensure a consistent, high-quality output tailored to your requirements.
Our AI-Powered Process for Writing CSRs
We have developed in-house AI tools to streamline the CSR creation process that enables our medical writers to deliver high-quality, submission-ready documents with efficiency and accuracy. Our dual AI and human approach reduces manual drafting, enhances traceability, improves submission speed.
Step 1: Automated AI-Assisted CSR Results Drafting
Using ARS-formatted output metadata, our automated AI-assisted reporting engine generates draft CSR Results sections aligned with CORE Reference guidance and CDISC standards. Drafts are designed for rapid review and editing, reducing turnaround times while maintaining compliance.
Step 2: Medical Writer Quality Control Review
Once a first draft is generated, our experienced medical writers review the output and make the necessary edits to finalise accurate, study-specific CSRs. This key quality control step is vital as it enables us to maintain scientific accuracy and compliance.
Step 3: Completed AI-Powered CSR, Ready for Submission
After our medical writers complete their review and make any necessary edits, the final CSR can be delivered for your regulatory approval. Our speed in writing CSRs enables us to handle scalable and high volumes of CSR deliverables.
CSR Support That Fits Your Study
Our bespoke AI-powered CSR offering can suit any study, across any phase and therapeutic area. At QInscribe, we can generate the following types of CSRs.
- Full CSR with Appendices & Publishing
A complete, submission-ready package including writing, appendix compilation, and publishing. - Full CSR
Robust reports covering study design, execution, and outcomes, alongside a clear, regulatory-compliant synopsis. - Synoptic CSR
Concise, high-quality CSRs designed for rapid delivery and internal use where speed is key. - Abbreviated CSR
Streamlined documents suited for fast-track submissions, while maintaining content accuracy and value. - Supplemental (Addendum) CSR
Detailed add-ons for post-hoc or exploratory analyses not included in the original CSR.
What You Gain by Partnering with QInscribe
Confidence in Regulatory Submissions
We ensure your CSRs meet ICH E3 and regional guidelines, reducing the risk of delays or rejections.
Faster Turnaround Without Compromise
We help you hit your regulatory milestones with CSRs that are written, reviewed, and finalised on schedule, all thanks to our AI tools and medical writing QC process.
Less Administrative Burden
We free up your clinical, biostatistics, and regulatory teams when you outsource CSR delivery.
Clear, Persuasive Communication
We ensure every CSR clearly communicates what was planned, performed, and observed, supporting confident decision-making.
A Scalable Solution
We can support one document or an entire portfolio, our services flex around your needs and timelines.
Let’s streamline your path to submission.
Talk to us about your upcoming CSR needs and how we can reduce pressure on your internal team, while keeping your trial timelines on track.