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Monday 9am - 5:30pm Tuesday 9am - 5:30pm Wednesday 9am - 5:30pm Thursday 9am - 5:30pm Friday 9am - 5:30pm

QInscribe

We are a specialist AI Medical Writing Contract Organisation that provides regulatory documents.

16/02/2026

🧾 Plain Language Summaries (PLS) are now mandatory under the EU Clinical Trials Regulation, and will be publicly available in the Clinical Trials Information System (CTIS).

In our latest guide, we cover:

✅ What a PLS is and how it differs from a scientific abstract
✅ EU CTR requirements and key timelines, including paediatric deadlines
✅ CTIS submission tips and common mistakes to avoid
✅ A strategic checklist to keep your summary neutral, clear and easy to read

Want to make sure your PLS is ready for CTIS the first time? Click here to read the blog: https://hubs.li/Q041WxCm0

13/02/2026

👀 A second set of eyes can make all the difference.

Our Regulatory Writing services provide independent, expert review to catch any inconsistencies within your documents.

☑️ Get full confidence with a final check. Learn how our QC specialists can help you reduce risk and avoid delays: https://hubs.li/Q041tlvh0

11/02/2026

💼 Ensure your Clinical Study Report includes clear and well documented outcomes with Patient Safety Narratives.

Whatever the volume of safety narratives you require to be written, our automated approach enables us to handle large volumes at scale without compromising on quality.

🔎 Discover how we can support your clinical trial with well-written, efficient, and compliant narrative delivery: https://hubs.li/Q041thql0

09/02/2026

📝 Clinical Trial Protocols set the tone for your entire trial.

We write and amend clinical study protocols with precision and care, reducing costly revisions, supporting faster approvals, and aligning with global regulatory standards from day one.

👀 See how we support your protocol development to drive your trial's success: https://hubs.li/Q041tc9-0

06/02/2026

👍 Confident submissions start with exceptional writing.

Our AI-driven regulatory writing services are designed to minimise queries, meet global standards, and keep your timelines on track, whether you need a full submission package or targeted support.

⚡ Discover how we support smarter, faster submissions for your clinical trial: https://hubs.li/Q040_dlV0

04/02/2026

🤔 Explaining key elements of your clinical trial in non-technical language that the general public can understand is a regulatory requirement.

Plain Language Summaries, AKA Lay Summaries, meet these requirements and help you communicate your trial results with transparency and accuracy.

🏋️ Support disclosure and stay complaint. See how we make your complex trial accessible and audit-ready: https://hubs.li/Q040_c2n0

02/02/2026

🚹 Anonymisation done right means less risk and fewer hang-ups with your clinical data and documents.

Our expert-led anonymisation services help you meet global transparency requirements while protecting participant privacy and commercial integrity.

Make sure your clinical data and regulatory documents are submission-ready and audit-proof.

👆 Anonymise your clinical data and documents here: https://hubs.li/Q040_8HW0

29/01/2026

📃 Registering your clinical trial and disclosing the results are a mandatory task for all drug developers.

Ensure you meet global registry and results posting requirements with the help of QInscribe. We handle all your registration and results disclosure tasks, reducing your admin and making sure you're complaint to these regulatory requirements.

⏱️ See how our team can support accurate, on-time disclosures for you: https://hubs.li/Q03-ch6H0

22/01/2026

📘 Investigator’s Brochure (IB) is more than a box-ticking document — it is the living “source of truth” for safe dosing, monitoring, and informed trial conduct.

In our latest guide, we break down:

✅ What an IB is (and why it matters under modern GCP expectations)
✅ The core sections along with what “good” looks like in practice
✅ Version control, annual review cycles, and out-of-cycle safety updates
✅ The EU/UK perspective on Reference Safety Information (RSI) and expectedness

👆 If you’re building or updating an IB for your next study, this is a practical checklist to bookmark: https://hubs.li/Q03_FPVC0

20/01/2026

🤖 Reduce the time to generate a first draft Clinical Study Report by 90% with QInscribe's AI-enabled CSRs.

We deliver CSRs that are clear, compliant, and submission-ready. Our AI tech assists in creating faster first drafts than ever before, coupled with the expertise you expect with human-in-the-loop review.

💻 Explore how we support high-quality CSR development at every phase: https://hubs.ly/Q03-c8BN0

15/01/2026

🔒 Clear consent builds trust and protects your clinical trial.

We develop informed consent documents that are accurate, accessible, and aligned with global ethical and regulatory expectations. We support you so you can support participants with compassionate and patient-centric communication.

👆 Learn how we support compliant, patient-focused ICD development: https://hubs.ly/Q03-c73m0

09/01/2026

🏆 High-quality medical writing doesn’t happen by accident.

Quality control and scientific review are essential to ensuring regulatory documents are accurate, compliant, and fit for submission. But what does a robust review process look like? And how can it help avoid costly delays?

👆 Our blog has the answers. https://hubs.li/Q03-8J6Y0

Address

Bevan House, 9-11 Bancroft Court
Hitchin
SG5 1LH

Opening Hours

Monday	9am - 5:30pm
Tuesday	9am - 5:30pm
Wednesday	9am - 5:30pm
Thursday	9am - 5:30pm
Friday	9am - 5:30pm

Telephone

+441462440084

Website

http://qinscribe.com/, https://www.linkedin.com/company/qinscribe/

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