Mature specialist solution
KALEIDOC EDC has grown from long-term project delivery and practical study requirements. This creates a steady, experienced alternative to oversized enterprise stacks or immature bleeding-edge tools.
Full-service EDC
for clinical trials and healthcare studies
Built around your study. Not the other way around.
KALEIDOC EDC is the flexible, validated, all-in-one Electronic Data Capture platform by INTrial-Services GmbH. Built on more than 25 years of EDC experience, it is a mature specialist solution grown from real clinical trial delivery, combining software, setup, validation, hosting, consulting and study-runtime support into one ready-to-use service.
25+
years EDC experience
65+
countries
100k+
patients documented
25k+
users
Why KALEIDOC EDC
A complete clinical data platform, delivered as a service.
KALEIDOC EDC is not a generic self-service tool that leaves your study team alone with configuration and validation. It is a mature specialist platform supported by clinical trial experts and technical specialists who understand the full study lifecycle. The result is a steady, known solution with strong price/performance, practical innovation and direct access to people who know how studies really work.
Use cases and study types
From early-phase trials to real-world documentation.
Because KALEIDOC EDC is highly configurable, modular and supported by an experienced setup team, it can be adapted to very different levels of study complexity, regulation, workflow and budget. This makes it suitable not only for large sponsored clinical trials, but also for smaller investigator-initiated projects, observational documentation, registries and structured healthcare data-capture workflows where a full, validated and practical system is still required.
All-in-one platform
Use one integrated platform for clinical data capture, patient-reported outcomes, consent, randomization, coding, reporting, dashboards, portals, reminders and data exchange. Common data products, such as integrated EDC/randomization or integrated EDC/ePRO, can be easier for sites, reduce duplicate work and improve overall cost efficiency. This avoids unnecessary fragmentation while still allowing project-specific integrations where they add real value.
Flexible by design
The study does not need to be forced into fixed software logic. KALEIDOC EDC is configured and extended around your protocol, workflows, data structures and operational needs.
Validated end to end
The system, setup approach and maintenance processes are designed for regulated studies with documented validation, traceability, audit trails and controlled change management.
Turnkey setup
Your clinical, data-management or medical experts define the study content, CRFs, workflows and requirements. We review those specifications with you, advise on feasible and innovative technical realization, and translate them into eCRFs, edit checks, workflows, testing, validation documentation and deployment.
Expert support
Consulting starts before study start and continues through setup, launch, amendments, runtime support, reporting, audit preparation and study closure. We also support project realization and innovation, with fast study setup and responsive handling of change requests and support requests. Customers work with personal contacts in our team, and additional services can be provided through our established partner network.
Qualified hosting
KALEIDOC EDC is hosted in qualified Germany/EU private-cloud environments, avoiding unnecessary non-European hyperscaler dependency and supporting data-residency expectations for regulated clinical research. Security controls include encryption in transit and at rest, role-based access, monitoring, backup/restore, disaster recovery and documented provider qualification.
Partner network
When a study needs more than EDC technology, our established partner network can provide additional services such as data management, statistics, medical writing, clinical operations support and specialized consulting.
Clear pricing
Use what your project needs, for as long as it needs it. Pricing is transparent and study-oriented, without complex license models or unnecessary long-term commitments.
Modules and extensions
Everything important in one connected ecosystem.
KALEIDOC EDC modules can be used as integrated parts of one study platform, combined flexibly, or provided as standalone applications where required.
eCRF / EDC
Data collection, verification, management, exports and analysis.
eCOA / ePRO / eDiary
Guided patient-reported data collection for better user experience and data quality.
eConsent
Patient consenting with focus on identification, content presentation and usability.
Randomization
Study-specific algorithms as integrated EDC module or external web service.
Coding
Medical coding with dictionaries such as MedDRA and WHO, including workflows and versioning.
Safety Reporting
Collection and transfer of safety data to support regulatory compliance.
Adjudication
Process management and data collection, including upload of supporting documents.
Reporting & Dashboards
Real-time lists, charts, KPIs, exports and operational monitoring.
Integrations & Exports
Study-specific imports, exports and interfaces for external tools, labs, devices, safety systems, statistics and data-management workflows.
Decentralized Trial Support
eConsent, ePRO/eDiary, patient portals and integration options help support hybrid or decentralized trial elements when required.
Qualified Hosting
Germany/EU private-cloud hosting selected and qualified for regulated applications, including monitoring, backup, security and continuity processes.
Patient Portal
Authentication, access management, health information and patient communication.
eFeasibility
Survey, qualification assessment, scoring and approval workflows.
Training System
Course content, qualification assessment and certification support.
Multi-Language
Language implementations including non-Latin scripts and right-to-left support.
Validation, compliance and data integrity
Validated software is only one part. Full validation also includes controlled setup, documented changes and maintained operation throughout the study lifecycle.
KALEIDOC EDC is designed for regulated clinical research. The platform combines a validated base system with documented project setup, controlled configuration, formal testing, validation reporting and change control. We have supported numerous sponsor audits and inspection-readiness situations, so audit evidence, controlled documentation and clear operating procedures are already part of the delivery model.
GxP, Part 11 and data integrity
Built for regulated electronic records and signatures.
KALEIDOC EDC is designed to support regulated electronic records and electronic signatures. This includes audit trails, role-based access control, controlled changes, traceable signatures, inspection-ready exports and data-integrity controls aligned with ALCOA+ principles.
Typical validation package:
depending on the project scope, this may include validation plan, specifications, risk assessment,
test plan and test cases, test reports, traceability matrix, validation summary report, change log and release approval.
GxP-oriented development and validation approach
Documented project setup and controlled configuration
Formal testing with traceability from requirements to test evidence
Validation summary, release approval and maintained validated state
Controlled change, amendment and maintenance processes
Germany/EU qualified private-cloud hosting
Backup, monitoring and disaster recovery processes
Audit- and inspection-ready evidence packs, logs and controlled documentation
Access management process with role concepts and periodic review
Modern authentication options including 2FA and passkeys
How we work
From protocol to go-live without the usual technical friction.
Our delivery model bridges the gap between clinical trial expertise and technical implementation. Your medical, data-management and operational experts bring the study specifications and requirements; our team understands how to realize them technically because of our long experience in clinical trial systems. Fast setup is possible because KALEIDOC EDC combines an optimized architecture, reusable validated components, many existing modules and established workflows. We like to work closely with other teams, challenge ideas constructively and build a good product together.
Review specifications and plan realization
We start from the study specifications provided by the sponsor, CRO, data-management team or medical experts, such as CRF content, workflows, interactions, user roles and reporting needs. We review them together, advise what is technically possible or advisable, and define the best implementation approach.
Configure and build
Based on the approved study specifications, our team sets up the study, builds eCRFs and modules, programs edit checks, configures workflows, prepares reports and integrates external data sources where needed. Reuse of established components and workflows keeps implementation fast, while project-specific configuration keeps the result tailored to the study.
Test and validate
Configuration, modules and workflows are tested against specifications. Validation evidence, traceability and summary documentation are prepared for audit-ready release.
Deploy and support
After approval, the study is released to the live environment. We support users, data managers, sponsors and CROs throughout runtime, with personal contacts, a responsible contact person and quick response to support requests, change requests and operational questions through an established request-handling process.
Maintain, amend and archive
Amendments, changes, updates, error handling, monitoring, exports, database lock support and archiving are handled through controlled documented processes.
Practical innovation
AI where it helps — not where it only sounds impressive.
We are not waiting for the big AI promise to magically solve clinical research. We have integrated AI features, but also automation and other technical improvements in practical places where they save time and improve workflows and usability. Typical examples are: extracting data from paper PROs, improving coding, assisting study setup, preparing eCRF structures and edit checks, creating training-video material, supporting automated translations, and helping with testing and verification activities.
New ideas and tools are added continuously as part of our daily work — sometimes AI-based, sometimes simply smart technical improvements. Before they are integrated, they are evaluated, tested and verified for practical value, data protection and validation impact. The goal is not to replace expertise, but to improve the study workflow: faster setup, more efficient data collection, better usability for sites and patients, cleaner data, and quicker support when something needs to be changed or clarified.
Pricing approach
Pay for the study you actually run.
KALEIDOC EDC is designed to be affordable and scalable for different study sizes and complexities, from compact studies to complex multi-country projects.
Simple and project-oriented
No complex licensing model, no unnecessary enterprise package, no long-term product lock-in. KALEIDOC EDC gives you the features, validation and support your study needs — without paying for modules or services your project does not require.
- ✓ Clear per-study pricing with strong price/performance
- ✓ Modules selected according to study needs
- ✓ Pay only as long as the project needs the system
- ✓ Right-sized alternative to oversized enterprise technology stacks
- ✓ Practical maturity instead of unnecessary bleeding-edge risk
Less work for your team
We do more than provide access to the software. Our team sets up the study, configures the modules, implements the workflows, supports validation and helps during study runtime. This reduces the workload for your internal teams and gives you direct access to people who understand both clinical trial processes and technical implementation.
- ✓ Study setup, configuration and validation support included
- ✓ Personal support before study start and during study runtime
- ✓ Support for amendments, reports, exports and audits
- ✓ Additional partner services available if needed, such as data management or statistics
Ready to see how KALEIDOC EDC could fit your study?
Tell us about your study specifications, modules, countries, languages and timelines. We will show you a practical setup path, discuss technical realization and innovation options, and provide a clear pricing approach.
More about INTrial-Services GmbH
KALEIDOC EDC is the central part of our clinical trial service portfolio. Learn more about our company, experience, services and partner network.