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Clinical Data Management

Clinical Data Management

The RPM Data Management group employs major technologies, processes and expertise to deliver each project specific requirement of our clients. The RPM team has extensive data management experience across a broad range of therapeutic areas and in clinical trial phases I to IV. Our consistency and commitment in providing efficient and cost-effective data management services of high quality to our clients leads to many alliances and partnerships. RPM ensures clinical data integrity by strictly adhering to accepted operating and review procedures throughout every stage of the trial. RPM delivers data management services in various widely accepted Electronic Data Capture (EDC) systems including REDCap Cloud, Medidata Rave, Medrio, Merge, InForm, Oracle Clinical, ClinCapture, OpenClinica, etc. Our clinical data management team has the expertise, dedication and flexibility to meet our global client needs. To ensure consistency in delivering data management services on a global basis, our data managers follow company specific standard operating procedures (SOPs) and ICH GCP guidelines and timely communication with our clients to meet their project needs throughout all phases of development and database specifications review.

Our comprehensive clinical trial data management services include:

  • Database design programming, specification, development and validation
  • CRF/eCRF design and development
  • Data validation checks (Form Control and Edit Check) specification, programming and testing
  • User Acceptance Testing (UAT)
  • CDISC (Clinical Data Interchange Standards Consortium)/CDASH (Clinical Data Acquisition Standards Harmonization)/SDTM (Study Data Tabulation Model) compliant CRF annotations and review
  • Data Management Plan (DMP) development
  • eCRF Completion Guidelines development
  • On-site and remote EDC training
  • System Integration and migration with clients' existing systems and processes
  • Double data entry
  • Discrepancy management and Query resolution
  • Clinical data review
  • Data tracking
  • Data reconciliations
  • SAE reconciliations
  • Integration and Verification of External Electronic Data
  • Status reporting
  • Data imports
  • Data exports
  • Quality Control Auditing
  • Manual and automated medical coding of medical history, indication for drug use, concomitant treatments and adverse events by trained medical monitors using standard coding dictionaries such as WHO-DD and MedDRA
  • Interim analysis
  • Database maintenance
  • Data extraction, conversions and archiving in various formats e.g. excel, SAS, csv, etc.
  • Database freeze and lock
  • Final database closure
  • Data transfers
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