Clinical Data Management

Irrespective of the fact that a particular trial is small, single Phase I trial or many, complex Phase III trial one would always look for ways to ensure that your organization is collecting and managing clinical data reliably, efficiently and in compliance with industry and government regulations. A small-scale scenario could involve an early-stage trial with limited patient volumes, where an organization wishes to quickly conduct a trial, entering data via traditional paper-based forms. A large-scale scenario could involve the collection of thousands of patient records, worldwide, accumulated from paper, EDC, and hybrid trials - all collected in one CDMS system as a means to store, manage and review clinical data and lab data across studies.

Paradigm Solution to Clinical Data Management

Paradigm has been successfully helping major global Pharma and CROs in all the phases of Clinical Data Management right from helping them streamline data entry and loading lab data, along with discrepancy management and resolution, patient and site reporting, data exporting, coding and system administration, regardless of the source (EDC or paper). In this context Paradigm played a crucial role in tracking the progress of our clients study at all stages to check its compliance towards the study objective by analysis of various metrics using Custom Reports generated in Crystal and BOXI . This apart we have customized the Outputs as per CDISC in client specific formats ranging from SAS to XML helping customers either to warehouse data across multiple projects right from pre-clinical to clinical phases or for regulatory submissions.