Accovion offers an Electronic Data Capture (EDC) solution that provides you the following benefits:

• One database system provided for all studies
• Database set-up and validation rules are processed in equivalent quality and manner as for paper studies
• Thoroughly tested queries are designed and verbalized to meet medical language
• Queries are reviewed prior to sending to the sites
• Data entry and validation is performed directly after your research data have been generated and entered into the system
• A switch to a paper CRF is possible at any time point during study conduct, even within one patient
• Data from external sources, e. g. from a central laboratory, can be uploaded into the system and displayed in the eCRF
• In-system coding is fast and on time
• All data are visible for the investigators, the monitor, the data managers and you – at any time
• Fast information flow supports decision making for key stakeholders.
• Access the system in a secured environment – information security is key – from your office
• Provision of a variety of clinical data management reports and status reports allows you to monitor your study progress in real time
• Full transparency and documentation of all user accesses and management of access rights (investigator, sites, monitors, data managers, sponsor, DMCs, etc.) is provided
• System training of all involved users is provided
• Self-explaining and detailed eCRF completion guide is provided
• RDC Helpdesk is available
• Accovion RDC on site uses the local IT infrastructure of the sites and does not require any downloads or software installations

User-friendly format

Accovion is currently using Oracle® Remote Data Capture Onsite Version 4.5.3, which bases navigation and data entry on user-friendly Web-based HTML formats.

The look and feel of Accovion’s eCRFs support ease-of-use for the sites. Accovion’s eCRFs look like paper CRFs providing data entry screens that support the daily routine at the sites (optically in order, easy to fill out, intuitive).

Fully validated and compliant

As with all computerized systems that Accovion uses, the Oracle Clinical Remote Data Capture Onsite system is fully validated and 21 CFR part 11 compliant.

Oracle® Remote Data Capture Onsite is a registered trademark of Oracle.