services

From our inception, the ClinDatrix vision has been to offer comprehensive, world-class CRO services to innovators in the pharmaceutical, biotechnology and medical device industries. Through our U.S.-based staff and global affiliates, we are a trusted choice for firms conducting Phase I-IV trials domestically or around the world.

Our core strengths enable us to guide our clients so that their studies yield accurate, reliable data. Our workflow processes and procedures are governed by a full suite of SOPs that are compliant with GCPs and ICH and FDA guidelines. Our equipment and systems include Oracle Clinical; Oracle Remote Data Capture (RDC) Onsite for global electronic data capture (EDC); Oracle Argus Safety; SharePoint customized as a global clinical trial management system; and LORENZ docuBridge for electronic common technical document (eCTD) submissions to regulatory agencies. All of our GxP systems are fully validated and managed using change control.

Everything ClinDatrix does, from protocol review and CRF design to clinical study reports and regulatory submissions, helps advance our clients along their product development pathways.