RPM Data Management group employs major technologies, processes and expertise to deliver each project specific requirements of our clients.
RPM team has extensive data management experience across a broad range of therapeutic areas and in clinical trial phase 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.Database design programming, specification, development and validationCRF/eCRF design and developmentData validation checks (Form Control and Edit Check) specification, programming and testingUser Acceptance Testing (UAT)CDISC (Clinical Data Interchange Standards Consortium)/CDASH (Clinical Data Acquisition Standards Harmonization)/SDTM (Study Data Tabulation Model) compliant CRF annotations and reviewData Management Plan (DMP) developmenteCRF Completion Guidelines developmentOn-site and remote EDC trainingSystem Integration and migration with clients’ existing systems and processesDouble data entryDiscrepancy management and Query resolutionClinical data reviewData trackingData reconciliationsSAE reconciliationsIntegration and Verification of External Electronic DataStatus reportingData importsData exportsQuality Control AuditingManual 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 MedDRAInterim analysisDatabase maintenanceData extraction, conversions and archiving in various formats e.g. excel, SAS, csv, etc.Database freeze and lockFinal database closureData transfers