Efficient trial management for sites

TrialSite optimises planning, administration and billing of clinical-trial participation, giving hospitals simple, efficient control over costs and timelines.

Clinical trials managed with full compliance

With TrialSite you digitise trial workflows, boost productivity and stay fully compliant with strict legal demands on documentation and billing.

WHAT IS
THAT?

TrialSite is a clinical-site management system built expressly for hospitals that act as trial sites in clinical research. It digitalises the entire administration workflow, from initial feasibility to final invoice. The platform’s overriding goal is full compliance with legal frameworks such as EU State-Aid Regulation 2014/C 198/01 and EMA GCP guideline 112288. By replacing paper tools with standardised digital processes, TrialSite unlocks synergies that translate into measurable productivity gains. Role-based access lets each stakeholder see only the functions and documents relevant to them; a tamper-proof audit trail captures every change. The system also supports Germany’s forthcoming Medical-Research Act, keeping sites competitive. Via a modern web interface teams manage documents, calculate budgets, record performed procedures and monitor finances—all in one secure environment hosted in EU-certified data centres.

WHY IS THAT
TOPIC IMPORTANT?

Running a clinical trial demands strict regulatory adherence plus meticulous documentation and billing. For trial sites this often means heavy administrative overhead. TrialSite brings these tasks together in a single workspace. A version-controlled document vault with read-confirmation workflows minimises legal risk; budget calculations follow EU State-Aid rules automatically, giving a defensible basis for sponsor negotiations. 

Real-time dashboards flag financial deviations early, while granular permissions protect sensitive data. The result: reduced admin effort, greater transparency, stronger finances and more time for patient care.

FOR WHOM IS THIS
TOPIC INTERESTING?

TrialSite serves hospitals acting as contract trial sites. Investigators, trial nurses and administrative staff gain one central tool for every compliance-critical task. Trial coordinators track recruitment and visit activities; finance teams rely on live billing dashboards; site leadership steers resources through real-time KPIs. Frequent sponsor negotiations benefit from transparent full-cost budgets. Whether you run a handful of investigator-initiated trials or dozens of global programmes, TrialSite scales with your portfolio.

Functions of the
TrialSite modules

TrialSite –
Trial Administration

The Trial Administration module is the backbone of the entire TrialSite suite. A fine-grained role-and-permission framework governs every other module and gives each user only the access they need. All trial-specific data are captured here: protocol IDs, ethics approvals, contracts, milestones and every document linked to the individual trial. Investigator CVs, delegation logs or training certificates can be uploaded once and retrieved in seconds; clear contact lists show who is responsible for what. Documents are versioned automatically and stored in a tamper-proof repository secured by granular permissions. Optional electronic read-confirmations prove that staff have reviewed the latest version, while expiry alerts ensure nothing slips through the cracks. Through the built-in portal interface, selected public facts—such as trial title, sponsor and enrolment status—can be published automatically on the hospital website, eliminating double entry and providing a single source of truth.

TrialSite Budget –
Full-Cost Calculation

The Budget module supplies trial sites with a defensible, EU-compliant cost basis for contract talks. It produces full-cost calculations that follow EU State-Aid Regulation 2014/C 198/01 down to the last euro. Users build reusable templates so a new budget is generated in minutes. Local cost catalogues—TVöD salary scales, imaging fees, overhead rates—are stored once and applied automatically. Every line item can be tied to a cost centre, investigator or visit, giving perfect traceability. Draft budgets pass through a built-in approval workflow: finance, pharmacy or radiology sign off their parts electronically, raising accuracy and auditability. The final sheet lists direct costs, indirect costs and allowable margins in a format accepted by CROs and auditors alike. Because the underlying logic and all historic versions are preserved, sites can defend their figures confidently and reuse proven templates for future trials.

TrialSite Finance –
Billing Module

Finance is the first module that lets a trial site capture performed procedures in a structured, paper-free workflow and convert them directly into invoices or SAP® billing orders. Study nurses log each visit or lab on a tablet; the data feed a live dashboard that tells management, in real time, how much income is earned and what remains unbilled. Internal and external services are separated by cost centre, simplifying intra-company charge-backs. Each provider sees a personal view of delivered but unbilled tasks, preventing disputes and lost revenue. Role-based rights allow the controlling team to pull numbers at any time and calculate work-in-progress at year-end with a single click. A reporting cockpit summarises every active trial with KPIs such as enrolled subjects, billed visits and cash-collection ratio. Real-time insight turns finance from a bottleneck into a steering instrument for the entire research portfolio.

Product overview TrialSite & TrialComplete

TrialSite compared with TrialComplete.

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Our services your benefits

TrialSite can also make trial administration and billing easier for you when participating in clinical trials.

Take a look at the benefits:

An illustration of the word compliant.

TrialSite fulfils EU State-Aid rules and EMA GCP guidance, so your trial participation remains lawful and efficient while aligning with Germany’s new Medical-Research Act.

An illustration of the word efficient.

Digital, media-break-free administration and invoicing: the billing engine automates invoice creation, and document versioning reduces compliance workload.

An illustration of the word transparent.

Automated reports and real-time dashboards give all stakeholders a clear view of costs and revenues; leadership always knows each trial’s financial status.

An illustration of the word secure.

Role-based access protects sensitive documents. All data reside in Telekom’s ISO/IEC 27001-certified EU data centres, ensuring full GDPR compliance.

How does TrialSite support the medical-research act?

Clinical-site management with TrialSite helps hospitals digitise and streamline processes so they can respond faster to trial requests and meet the Act’s requirements.

Does TrialSite provide EU-compliant cost calculation?

Yes. The Budget module generates full-cost calculations under EU State-Aid Regulation 2014/C 198/01, giving sites a solid basis for sponsor negotiations.

Which security standards does TrialSite meet?

All data are stored in Telekom-owned, ISO/IEC 27001-certified data centres in Germany and the Netherlands and are fully GDPR-compliant.

Can TrialSite be integrated with TrialComplete?

Yes. Integration with TrialComplete enables seamless transfer of documents and progress data, boosting efficiency across both platforms.

What future features are planned for TrialSite?

Planned enhancements include AI-driven digitisation of multi-page visit schedules, support for multi-site trials and an expanded reporting suite. These are roadmap items and will be released based on demand and priority.

What is the difference between TrialSite and TrialComplete?

TrialComplete focuses on the management and organization of the entire clinical trial and accompanies the process from planning to evaluation of the trial data (clinical trial management). TrialSite, on the other hand, focuses on the management of the clinical trial sites themselves and optimizes administrative processes such as cost calculation and billing (clinical site management).

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