Clinical Evidence · Regulation · AI Employee Crew
Clinical evidence, regulation, and an AI employee crew for health startups.
Two ways: as consulting, SaMD clinical validation, CER statistics and regulation; or as an AI employee crew that runs on your own machine.
Peer-Reviewed Publication
Clinical research published in an international peer-reviewed journal, 2026.
PROSPERO Registered
Active PROSPERO-registered systematic reviews, at international methodology standards.
Clinical Network
Research collaboration across multiple hospitals and clinicians in different specialties.
Technical Depth
End-to-end systems built, including DICOM pipelines, deep learning segmentation, and data curation. Work examples.
New · For Health and Medtech Startups
An AI employee crew for health startups.
For medtech, biotech, digital health, diagnostics, and medical device startups; AI employees dedicated to regulation, quality, research, and business-intelligence roles. They do the work and report back to you; nothing is sent, filed, or published without your approval. Local-first and bring-your-own-key: your sensitive data stays on your own machine. We build the crew as Serteser Danismanlik and power it with regulatory expertise.
Service Segments
Clinical evidence for industry, method for academia.
Industry
Medical-AI & SaMD
Standalone clinical validation study, CER statistics core, RWE protocol and SAP, and CRO biostatistics for AI medical devices. TITCK-CDSS / EU-MDR / FDA. USD-based.
Clinical evidence services →
Academic
Research & Method
Thesis and manuscript statistics, full systematic review process, meta-analysis, power analysis and ethics committee support, TUBITAK applications, and medical AI study design.
Academic services →
Enterprise
Data & AI
Company data pipeline setup, AI tool training, prompt engineering workshops, web and app integration, and custom model development.
Enterprise services →
Guides
Reading before you start.
Free, practical guides on statistics, systematic reviews, and meta-analysis.
References
From the academics we work with.
Academic title and scope of collaboration are shared instead of names.
It was a huge help in avoiding a manuscript mess in a field I did not know. Seeing the methodology and meta-analysis process done with such care matters a lot.
Assoc. Prof. Dr.
Systematic review and meta-analysis collaboration
We ran the entire technical process together, from the ethics committee application through data collection and analysis. Fast and meticulous work.
Asst. Prof. Dr.
Clinical research and AI study design collaboration
Congratulations, a very meaningful study. Thank you for your efforts.
Prof. Dr.
Joint systematic review study
Publications and Records
Peer-reviewed publication, open record.
Led by a biomedical engineer (BME MSc) with published methodology, a peer-reviewed publication, and PROSPERO-registered systematic reviews.
Peer-Reviewed Publication
AI-assisted clinical research published in an international peer-reviewed journal (2026).
PROSPERO Registered
Systematic reviews and meta-analyses registered on PROSPERO, conducted in line with PRISMA 2020 and Cochrane RoB 2 standards.
First Step
Let us talk first, then a proposal.
A free 15-minute intro call. We clarify the scope and draw up an impartial roadmap. Pricing is USD-based; payment is collected in TL at the TCMB rate on the day of the call.
or email directly: burak@serteser.com.tr