Clinical Operations
Modern pharmaceutical research relies on the integration of various IT systems when conducting clinical trials: CTMS for trial logistics, EDC for patient data, RBM for risk monitoring, eTMF for documentation, and biostatistics for data analysis. We have hands-on experience with these systems, integrate them into seamless data flows, and thereby help ensure that trials operate on a robust technical foundation.
Clinical IT capabilities at a glance
Where scientific hypotheses become clinical evidence
Clinical Development defines the study program, the protocol strategy, and the regulatory pathway. It determines which studies will be conducted and how. Clinical Operations implements this program on the ground: from site setup and investigator management to data collection and handoff to Regulatory Affairs. Both functions place different demands on the IT infrastructure—and we are familiar with precisely these demands and processes from our day-to-day work. We do not view IT systems as individual tools, but rather as an interconnected stack: what is recorded in the EDC determines what the biostatistics team can analyse, and what is maintained in the CTMS determines whether the eTMF is ultimately fit for inspection.
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
Clinical Trial Management Systems (CTMS) and Randomization/Trial Supply Management (RTSM/IRT) serve as the operational control center for every clinical trial. We handle system management, architecture, and lifecycle support for the core CTMS platforms - drawing on our experience with Veeva Vault CTMS and Parexel IMPACT - and integrate them into the broader clinical IT landscape. From site management and investigator oversight to milestone tracking.
A properly implemented CTMS reduces the manual overhead involved in site management and identifies milestone risks earlier - before they jeopardize the study timeline.
Clinical Data Capture & Risk-Based Monitoring
Electronic Data Capture (EDC) serves as the hub connecting clinical findings to an analyzable dataset; Risk-Based Monitoring (RBM) transforms static study protocols into an adaptive risk model. We manage system administration and data architecture for Medidata Rave (EDC) and CluePoints (RBM) - including dashboard design, KRI definition, and study setup. Data flow and integrity are not added as an afterthought but are built into the architecture from the outset.
An architecture that has been carefully designed from the start ensures a seamless flow of data, the highest level of data integrity, and optimal analyzability.
Trial Master File & Documentation
The Electronic Trial Master File (eTMF) serves as the central evidence of Good Clinical Practice—from study setup through regulatory inspections. We support system management, data architecture, and standardization for Veeva Vault eTMF, integrate supporting document management systems such as Vault Qdocs, and ensure the end-to-end lifecycle of study documentation.
An Electronic Trial Master File (eTMF) ensures complete, regulatory-compliant trial documentation—a critical factor for successful approval.
Biostatistics & Statistical Programming
Statistical analysis is only as reliable as the environment and the data it is based on—and that is precisely where we come in. We operate Sycamore SCE, manage JMP-based analysis platforms and the associated SAS environment, and are responsible for study setup, platform administration, and validated data integration through to the point where data sets are ready for analysis. The statistical programming itself remains the responsibility of the biostatisticians.
A robust system environment ensures validated data integration and data sets suitable for analysis.
Clinical IT in combination with Data, Validation, and Control
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.
Platforms and Systems of the clinical IT landscape
A selection of the systems we work with in practice - platform-independent, with a focus on the customer's ecosystem
Studies that involve patients more closely
Decentralized and hybrid clinical trials are currently one of the fastest-growing topics in clinical operations. Patient-centric trial design, remote patient monitoring, eConsent, ePRO, and the integration of wearable data into the clinical stack are fundamentally changing the operational model. We are aware of this development and support our partners in this area as well, going far beyond the traditional, site-centric trial model.
Central Aspects
Integration of eConsent and ePRO into the EDC stack
Remote Source Data Verification
Integration of wearable and sensor data
Patient Portal Integration
Admissible data is the result of a well-functioning infrastructure
At the end of every study, there is a collection of clinical and surgical data—its completeness, integrity, and analyzability determine whether the study qualifies for approval. The IT infrastructure must ensure that this data is collected accurately, completely, and in a manner ready for audit, from the patient’s first visit through to the final dataset. This is exactly where we come in.
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.