For nearly 20 years OPIS has been a reliable cost-competitive clinical drug development partner to Sponsors from the Pharmaceutical, Biotechnology and Medical device industries. OPIS Germany GmbH located in Munich, represents the OPIS group on the German market.
The company offers flexible service packages for all aspects of interventional and non-interventional clinical studies. Apart from local regulatory expertise, quality project management and monitoring, OPIS provides clients with an in-house developed fully validated and highly customizable, modular EDC platform to streamline digitalization of clinical trial data.
CLINICAL.NET has the following service modules:
- Study Management and Coordination
- Electronic Trial Master File (eTMF)
- Electronic Case Report Forms (eCRF)
- Electronic Patient Reported Outcomes (ePROs)
- Adaptive risk-based Monitoring
- Integrated IVRS/IWRS for centralised randomisation
- Study drug management
- Protocol deviation
- Online Audit trail
- MedDRA und WHO coding
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