Clinical Data Management

Stark Associates offers end-to-end clinical data management services for life sciences companies across the globe with its chain of partnerships across technology players and niche providers in its quest to provide clinical services to its clients. With a remarkable experience in clinical study database building activities using multiple EDC systems, including Medidata RAVE, Oracle platforms, we offer flexible expertise that work on multiple EDC systems, as per client preference. This diverse experience and domain knowledge has provided us with the leverage of building studies in a shorter span of time.

  • Develop and manage data management and submission plans
  • CRF/eCRF design, production and review
  • CRF Annotation, Database design, development & deployment
  • CRF Review and Tracking
  • Single Data Entry/Double Data Entry and Source Data Validation / Verification
  • Query Management
  • Implementation and use of current data standards (SDTM, CDASH, and other CDISC models)
  • Data conversion to any sponsor's data specifications
  • Interim Analysis Readiness
  • Medical Coding (Adverse Events, Medication and Laboratory)
  • Serious Adverse Event (SAE) Reconciliation
  • Customized status reporting and generation of data listings
  • Data extraction, database lock, closeout and delivery
  • Flexible, configurable, scalable, and auditable infrastructure with 21 CFR Part 11 compliance