Our services
Two packages – depending on your needs
Package 1: Lean Oversight (Phase I–III)
Sponsor-side functional oversight for Data Management and Biostatistics — acting as your single point of contact for both functions, reviewing and challenging key deliverables, and providing decision-ready reporting to keep your study on track while working with sponsor-appointed partners (e.g., CROs, labs, specialist vendors).
Package 2: Study Planning & Conduction (Early Phase)
End-to-end early-phase study planning and delivery for small studies (<100 patients) — from protocol and set-up through execution and close-out — with integrated Data Management, Biostatistics, and Programming, plus trusted partners integrated as needed (e.g., Clinical Operations, Monitoring).
Our core competences
Data Management
user-friendly & compliant
- We design eCRFs that are intuitive and easy to use
- Ensure smooth collaboration across teams and systems
- Central data review listings help detect issues early
- Continuous query management keeps data as clean as possible
- Full traceability and audit logging with transparent documentation through database closure
- Confidently ready for inspection
Programming
submission-ready
- SDTM & ADaM programming built on clear specifications
- SAP development (shells, derivation rules, mock TLFs)
- TLF programming that supports decision-making and study outcomes
- Risk-based QC, double programming, and code review
- Fully aligned with protocol and submission standards and audit-ready documentation
Biostatistics
clear, rigorous, reliable
- Study design grounded in solid scientific and regulatory insight
- Sample size planning and power considerations, aligned with endpoints and assumptions
- Protocol support (endpoints, estimands, analysis concepts) in close collaboration with clinical data team
- Estimands framework (ICH E9(R1)) to clearly define study questions and handle intercurrent events
- Proven quality from statistical planning through final Clinical Study Report.
Free check-up consultation
Tell us where you stand — and what you need.
We’ll tell you frankly how lean (or robust) your setup should be, so you can get off to a strong start and stay ready to make decisions as your study evolves.