MANAGING CLINICAL DATA… Your Way

Present-day management of clinical data encompasses a complex set of activities that are expertly managed by PROMETRIKA’s highly experienced staff. Our clinical data managers and in-house database programmers collaborate with sponsors through all phases of data collection, database build, data review, and database lock to deliver the highest quality data.

PROMETRIKA works closely with sponsors to determine specific clinical trial technology requirements and customizes the implementation to meet unique clinical data storage and data processing needs. We have extensive experience in leading EDC platforms. Our data management team is capable of working within any EDC system selected by our sponsors, and we are a Medidata CRO Partner. Our expert team can recommend and implement database enhancements to simultaneously improve the clinical sites’ end-user experience and data structure for statistical analyses. We have standard processes for the integration of data with external vendors, such as core laboratory and medical imaging, to improve the speed of third party data acquisition and review, thereby improving data quality and minimizing timeline risks.

SERVICES

Clinical Data Management

  • Data Management Plan
  • Custom Metric Reports Design & Programming
  • Data Analytics Dashboard
  • eCRF Development
  • Global CRF Library Design
  • Data Review
  • AE & SAE Reconciliation
  • Medical Coding
  • Database Lock & QC Audit

Database Programming

  • Database Design & UAT
  • Custom Function Programming
  • URL Management
  • User Access & Site Support
  • Data Validation Programming
  • API Mapping for External Data Integration
  • Electronic Data Integration
  • Legacy Data Integration
  • Custom Solutions to Meet Individual Trial Needs

PROMETRIKA’s Data Management Team — A Snapshot

  • Average of 15 years of experience
  • Certified Clinical Data Managers (CCDM)
  • Certified Rave study administrators & builders
  • Experienced MedDRA and WHODrug coder