The platform decision shapes study efficiency, budget and regulatory readiness for the whole investigation, and it is usually made before the people who will live with it are consulted. Eclevar MedTech has no software partnership to defend, so the assessment starts from your study rather than from a product.
Chief Data Officer
Biometrics & Data Systems
in clinical data systems, biometrics and statistical reporting
Head of Quality & Compliance
ISO 14155 & data integrity
in quality systems and inspection readiness for device studies
Chief Operating Officer · former TÜV SÜD Senior Reviewer
in device evaluation and Notified Body review
An EDC platform is where investigators enter study data directly, letting sponsors and data managers review it in near real time. It carries eCRFs, visit scheduling, edit checks, query management, audit trails, access control, electronic signatures, exports and integrations.
Platform selection is part of clinical data management and is documented in the data management plan. Our own platform capability is described on the EDC and data management page and the eCRF platform page.
Before evaluating vendors, answer these. The answers eliminate most of the market and make the demonstrations useful.
How many sites, how many participants, how many countries. A feasibility study and a multinational pivotal trial do not need the same platform.
What is collected, and by whom. Clinical assessments, imaging, laboratory results, device output, patient-reported outcomes.
Whether laboratory, imaging or device data will arrive from other systems, and on what schedule.
Complex visit schedules, dynamic forms, multiple user roles, medical coding, advanced reporting, risk-based monitoring support.
Whether the investigation involves wearables, telemetry or connected medical devices feeding data continuously.
Whether this platform has to carry the next study too, including post-market follow-up that may run for years.
Hosting location, transfer rules and site-level language requirements are selection criteria, not implementation details discovered later.
Language versions, screen readability and national wording are settled before the database is frozen, because changing a live form costs a validation cycle.
Feature lists all look similar. These are the criteria that separate platforms once a real study is loaded into them.
Secure audit trails, electronic signatures, controlled user access, data traceability, system validation, backup and recovery, supporting ISO 14155, the EU MDR, ICH GCP E6, FDA expectations and 21 CFR Part 11 where applicable.
Request demonstrations and let coordinators and CRAs run typical workflows. A system investigators are comfortable with reduces training, improves accuracy and shortens entry delays.
Drag-and-drop building, reusable templates, conditional logic, dynamic fields, standard libraries and version control, without heavy programming. See eCRF design.
Range checks, logical consistency, cross-form validation, required field validation, date verification and duplicate detection.
Central laboratory systems, imaging platforms, ePRO applications, randomization and IRT, CTMS, wearables, and electronic health records where applicable.
Enrollment dashboards, query metrics, missing data reports, site performance indicators, and exports the biostatistics team can use directly.
A lower headline price often means a higher total cost, because the flexibility you did not buy becomes work someone has to do.
We quote platform-related work on the same basis as our European clinical trial cost benchmarking, so the platform decision can be compared against the rest of the study budget rather than in isolation.
Some data management providers work exclusively with one platform. We do not, and it changes what the recommendation is worth.
The mistakes that cost most. Selecting software before defining requirements, prioritizing price over fit, ignoring investigator usability, overlooking integration needs, underestimating protocol amendments, leaving data managers out of the decision, and buying capability far beyond the study complexity.
Confirm the system supports your study design, meets the applicable regulatory requirements, is intuitive for investigators and coordinators, offers flexible form design, includes meaningful validation, supports your external data integrations, provides reporting you will use, scales to future studies, comes with reliable support, and fits the long-term strategy of the organization.
Published work and client evidence, not claims.
Where the platform decision sits in the wider data lifecycle.
The EDC system is the software platform used to collect and manage clinical data. The eCRF is the electronic form inside that platform where investigators enter study data.
Technically yes, but it is complex. It may require data migration, additional validation and regulatory documentation. Selecting the right system before study initiation is strongly recommended.
No. The best system is the one that fits the study complexity, the regulatory requirements and the operational needs. A simpler platform is often more appropriate for smaller or less complex investigations.
Most modern platforms can be configured for device investigations, but they differ in how well they handle device-specific workflows, external integrations and long-term scalability. These capabilities are worth testing during selection rather than assuming them.
Yes. We are vendor-independent and regularly build and manage studies in the sponsor platform.
Data management, clinical operations, biostatistics and regulatory, plus at least one person who will enter data at a site. A decision made without the data managers is the one most likely to be revisited mid-study.
Send us the protocol, the country and site count, the external data sources and any platform already under consideration. We come back with a requirements matrix, the shortlist that fits, and the questions to put to each vendor.
Your documents are reviewed confidentially. An NDA can be put in place before we receive any technical or clinical information. You can also reach the team through the contact page.
Whitepaper, BSI and Eclevar
on the EU MDR
Client testimonial,
RegenLab