Custom clinical trial software

Clinical trials need systems that guarantee traceability, data integrity and regulatory compliance, while fitting the real processes of sponsors, CROs and sites. Depalop builds clinical research software from its own proven platforms or from scratch, to your specifications.

eTMF – electronic Trial Master File

Study document management with a structure configured through a data dictionary, custom milestones, versioning and audit trail. Discover eTMFlex

eCRF and data capture

Custom electronic case report forms, or design and customization of studies on REDCap. REDCap consulting

Safety database and pharmacovigilance

Management of serious adverse events (SAE) according to CT-3 and GVP, integrable with eCRFs such as REDCap, custom systems and Excel files. Discover SafetyDatabase

Clinical logistics and biological samples

Traceability of shipments between sites and laboratories, with automatic notifications and central controls. Discover Logistic

Investigational product management

Requests, distribution, confirmations and disposal of IMPs with batch monitoring. Discover eCDS

Every system is designed with regulatory requirements built in: audit trail, role and permission management, electronic signatures where required, data protection under GDPR. On request we provide the validation package according to GCP, EU Annex 11 and FDA 21 CFR Part 11. Validation and CSV

1. Process analysis and user requirements (URS).
2. Functional specifications and a prototype to review with your team.
3. Iterative development with releases to a test environment.
4. Validation, training and go-live.
5. Maintenance, upgrades and ongoing support.

We work with pharmaceutical and biotech sponsors, CROs, research hospitals, foundations and cooperative groups running commercial and non-commercial studies.

Managing a study process with email and Excel today? Let's talk.

Contact us