CRO Inflamax Research, specializing in proof of concept and phase I through IV studies in allergy, asthma, ocular and dermatology utilizing EEC technology, has expanded its eSource clinical data management (CDM) services.
The CDM team has built, released and “locked” 375 databases since 2006 in multiple study designs and therapeutic areas. All team members are members of the Society for Clinical Data Management (SCDM) and all have achieved their Certified Clinical Data Manager (CCDM) status.
The utilization of CDISC and CDASH standards provides the industry-standard data exchange models, which facilitate submission for FDA requirements. In addition to data management services including web-based fully compliant 21 CFR Part 11 electronic data capture capability via secure internet access, Inflamax Research has integrated its eSource data capture in the clinic into good data management practices. This includes the company’s electronic Patient Data Acquisition Tablet (ePDAT) on which patient-reported outcomes are input directly and then captured securely and directly into the database.