Clinical Operations
Clinical trials are highly regulated initiatives running on a range of specialised IT systems — CTMS, EDC, RBM, eTMF and biostatistics platforms. We know the tools, the methodology and, above all, the connections between them: from trial management through to statistical evaluation.
Clinical IT capabilities at a glance
Where scientific hypotheses become clinical evidence
Clinical Operations and Clinical Development form the heart of pharmaceutical value creation — where scientific hypotheses, through controlled trials, become clinical evidence. A number of specialised systems work together to make this happen: CTMS for trial logistics, EDC for data capture, RBM for risk-based monitoring, eTMF for regulatory documentation and biostatistics platforms for analytical evaluation. The real challenge rarely lies in a single system, but in how they interact: breaking up system silos, smoothing data flows, enabling integration across the trial lifecycle. That is precisely where our contribution comes in — depth in the individual systems combined with the architectural understanding of the clinical IT landscape as a whole.
Four focus areas along the trial lifecycle
From trial logistics through to statistical evaluation — each step with the system depth and integration experience that clinical IT landscapes demand.
Clinical Operations & Trial Management
CTMS systems are the central hub of a clinical trial — site management, investigator oversight, milestone tracking, regulatory compliance. We operate Veeva Vault CTMS and Parexel IMPACT in production, integrate them into the surrounding clinical system landscape and support trial teams in day-to-day use — from architecture through service management to operational business support.
Clinical Data Capture & Risk-Based Monitoring
EDC systems such as Medidata Rave capture patient data during a trial, replacing the classical paper CRF. Risk-Based Monitoring — for us primarily with CluePoints (RBQM) — turns the oversight of this data into a data-driven discipline: central dashboards, Key Risk Indicators, real-time detection of safety signals and outliers. We bring both worlds together, from system operation to data architecture.
Trial Master File & Documentation
The eTMF is the digital evidence trail of a clinical trial — the repository that proves a trial was conducted in line with Good Clinical Practice and regulatory requirements. We run and integrate Veeva Vault eTMF and support the surrounding document landscape around Veeva Vault Qdocs — with the focus on clean data flows, consistent standards and audit-grade structures.
Biostatistics & Statistical Programming
Biostatistics turns raw clinical data into the evidence that demonstrates efficacy and safety of a therapy. We operate Sycamore SCE (Statistical Computing Environment) as the central statistics platform and support JMP setups including SAS code development and JSL add-in development. Integration with the surrounding data world — Python, R, Power BI — for reproducible, audit-grade statistics.
Clinical IT delivers its impact in concert
Clinical systems never stand alone — they produce data that needs to be evaluated, are subject to compliance requirements and need disciplined governance across trials and programmes.
The tools of the clinical IT landscape
We work with the systems established in pharma clinical operations — with focus on the Veeva Vault family and the leading specialist systems for EDC, RBM and biostatistics.
Clinical trial IT thought through as a whole
From CTMS operations to cross-trial data architecture — we bring system depth and integration experience from a single source.