Fit-for-purpose trial oversight and conduct
Stable at the core
Built around strong Biostatistics and Data Management
— aligned with clinical operations, vendor delivery, and
sponsor-side oversight.
End-to-end – from protocol design to archive
Biostatistics, Programming, and Data Management are at the core.
Everything else can be added modularly —depending on your study stage.
We provide overarching leadership and integrate your ecosystem: internal teams (Data Managers, Programmers, Biostatisticians), external partners (e.g., Clinical Operations, Monitoring), EDC providers, and specialist vendors—as needed, as lean as possible.
Sponsors receive a clear, up-to-date overview of data and study status at any time—so progress, risks, and next actions are visible at a glance.
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.