Data Management & Biometrics

  • Full Service Clinical Data Management

    End-to-end support for Clinical Data Management System (CDMS) set-up, integrations, data cleaning and reporting, vendor management, and database lock across a wide variety of therapeutic areas, with a commitment to transparency and excellence.

  • Full Service Medical Coding

    Offering development and management of Coding Plans.  Coding services range from manual coding options to CDMS setup and implementation of medical coding, utilizing standardized medical coding dictionaries, including but are not limited to MedDRA, WHODrug, WHODrug ATC 5 and COSTART ensuring consistency and accuracy of coding.

  • Full-Service Data Entry

    Providing Clinical Study Coordinator (CSC) data entry services for sites with rapid enrollment and/or sites requiring additional resources.  The focus of our CSCs is data accuracy, assisting with query resolution, optimizing the safety of research subjects by assisting with Adverse Event reporting and much more.  The CSC work ethic and outputs reflect our commitment to efficiency and integrity.

  • Biostatistical Services

    Supporting all statistical needs with the implementation of statistical methodology for clinical plans and protocol development, Randomization Schemes, PK analysis Plans, Table Figure and Listings (TFLs), CDISC, ADaM and much more.  Our Biometrics team focuses on providing sound scientific principles to guide every aspect of our operations.