Clinical Data Management

Element's Data Management service offering addresses the recent regulatory requirements for CDISC compliance and encompasses GCDMP principles. Element provides customized solutions aimed at reducing Data Management costs, improvement in data quality, portability of data for further analysis and accountability. Our cost-effective models allow us to combine resources for a custom approach that precisely meets your needs.

We support EDC, paper and hybrid studies on all major platforms available in the industry. Our Data Management Services are supported by a strong project management team to identify potential problems before they happen and keep the project on track. The Data Management team includes Life sciences graduates, Doctors, Database experts, Information Security, IT and Infrastructure specialists. We are a process driven company and we follow SOPs with rigor.

      ::   CRF / CDISC compliant Database Design
      ::   CRF Annotations
      ::   Study setup and configuration
      ::   Edit-check specifications and programming
      ::   Validation procedures
      ::   Test data entry
      ::   Double data entry
      ::   User Acceptance testing and multiple site rollout
      ::   Discrepancy management
      ::   AE and SAE reconciliation
      ::   External data load
      ::   CDISC ODM compliant data transfers
      ::   Database Lock and closeout
      ::   Data extracts
      ::   Data archival

Element has strategic alliances with leading Data Management tool vendors to provide its customers a choice of the best paper based, EDC and hybrid tools available. We provide the following data management services using RAVE, Oracle Clinical, Oracle Clinical RDC, Inform and ClinTrial products.

Element provides both offsite and blended service models, a combination of offsite and offshore models for your Data Management. A typical offsite team structure would include a Project Manager, Clinical Data Manager, Clinical Database Programmers, Clinical Data Coordinators, Medical Coding specialists, DBAs and Data Entry Associates.

In a blended service model, offsite team would comprise of a Project Manager and a Clinical Data Manager and the offshore team will have an Offshore Data Manager and the rest of the team. Resource intensive activities such as data entry, medical coding and data clarification activities when pushed to offshore will result in significant cost savings, while Project Manager and Data Manager's presence in offsite, NJ ensures that communication channels with the client are efficient.