The Derby Clinical Trials Support Unit offer bespoke electronic Case Report Form (eCRF) / study database design and construction through an online partner vendor – Dacima™ Software.
This service can be provided as part of the CTU data management services to provide the investigators with an online validated eCRF / study database for their trial and as a stand-alone service to commercial Sponsors, who want to outsource this service to an external vendor.
The stand-alone service includes:
- eCRF / study database design based on Clinical Data Acquisition Harmonisation CDASH standards
- development of the eCRF / study database, including dynamic forms and visits
- implementation of system edit checks
- assignment of appropriate user access rights
- User Acceptance Testing (UAT) of the eCRF / study database and the system edit checks
- release of the eCRF / study database to live environment
- the ongoing support for eCRF / study database updates
- experienced team with developing validated eCRF / study database with Dacima™ Software and Medidata Rave EDC©
The Dacima™ Software is user-friendly, innovative, powerful and flexible web/cloud electronic data capture (EDC) software application that allows users to easily create professional quality clinical databases for all types of different study designs and database requirements, including clinical trials, patient registries, observational designs, web surveys and eDiaries. The system has integrated modules for web randomization (IWRS), drug allocations and inventory management, emergency unblinding, electronic patient reported outcomes (ePRO), an alert center, MedDRA coding and WHO drug dictionary coding. The system is compliant with General Data Protection Regulations (GDPR), Good Clinical Practice (GCP) and FDA 21 CRF part 11.
Please get in touch with us as soon as you have a research idea so as to get the appropriate support.