Data Management

Sitero provides Technology-driven solutions for clinical data management to drive faster trial completions, improve data availability, and maximize efficiencies across the drug development lifecycle.

Our clinical data management teams produce results that are verified at the source, delivering an end output with the transparency, integrity, accuracy, and speed required to meet all regulatory and business requirements.

Data Management Services

  • Database design, development, and maintenance

  • Data entry, data verification, and data cleansing

  • Medical coding setup and implementation
  • Case Report Form (CRF) design utilizing the most up to date SDTM implementation guides
  • Electronic data integration

  • Data query generation and maintenance

  • External data import and reconciliation

  • Medical coding using WHODrug & MedDRA dictionaries
  • Serious adverse event (SAE) reconciliation
  • Management and integration of local laboratory reference ranges with CRF data

  • Integration, verification, and reconciliation of external electronic data

  • EDC selection and end-user training
  • Database lock and archival
  • Database transfer

Other Clinical Services

Clinical Operations - Clinical Services Sitero

Clinical Operations

Our clinical operations team will work with you to optimize clinical trial design, implement patient-centric approaches, and guide you through the entire clinical development lifecycle.

Biostatistics - Clinical Services Sitero

Biostatistics

Sitero offers a full suite of biostatistics and programming services to support your clinical research needs across a variety of therapeutic areas and specialties.

Medical Writing - Clinical Services Sitero

Medical Writing

Sitero provides high quality medical writing services for Biotech, Pharmaceutical, Consumer Health, and Medical devices companies across the Globe. Our team of well qualified and experienced Medical Writers have deep experience in writing Regulatory, Clinical, Scientific, and MedCom areas.