Cloud EDC / CTMS

We have developed a 21 CFR Part 11 compliant flexible clinical data collection and data management system, offered as Cloud Software as a Service – SaaS in a secure technological infrastructure, that can be easily adapted to complex requirements, allows the quick and robust set-up of a trial’s database and forms, and offers real-time monitoring of trial progress and of data quality and risk indicators through dynamic reports and data visualisation. The system is validated by applying an ISPE GAMP5 GxP validation process and is compliant with all FDA and EMA requirements governing the use of computerised systems in clinical trials.

The architecture and design of our clinical data software is based on clinical trial metadata, i.e., definitions and concepts, while a generic, flexible clinical database supports the dynamic generation of forms, queries and reports as well as the dynamic implementation of declared validation rules and information flows. 

The system supports CDASH compliant eCRFs as well as the automatic generation of CDISC/SDTM datasets using our innovative SDTM generator module, which is based on metadata and allows the creation of SDTM datasets with no traditional programming.

Our agile technologies and software development methods and tools allow the quick adaptation of the system to the trial’s specific needs and the quick development of custom functionality and tools if required, including IWRS, PRO (Patient Reported Outcome) / COA (Clinical Outcome Assessment), processing of medical imaging data with multiple expert assessment and adjudication etc. 

The software is developed according to SDLC (Software Development Life Cycle) SOPs and is validated following ISPE GAMP5 validation guidelines for GxP computerised systems to ensure compliance to regulatory requirements for clinical data information systems, such as per FDA and EMA regulations and 21 CFR Part 11 or EU Annex 11.

The cloud service is hosted in a secure IT infrastructure and is managed using an ISO 27001 compliant ISMS (Information Security Management System) including all the processes and organisational and technical measures and controls to ensure data integrity and information security.

Our system has been successfully used for more than 50 multi-site clinical studies for more than 20 pharmaceuticals, biotech and CROs, including large multi-national studies, blinded Phase I, II and III trials with IWRS randomisation support, large sample observational studies and patient registries, and used until now by more than two thousand users (investigators and monitors) for more than 25.000 study participants.

Our software is supported by a team of software engineers with in-depth experience in clinical data requirements and clinical process flows.