Biometrics

    Our experienced Biometrics team works to carefully design and execute programs to ensure the data are reported, displayed and captured effectively

    Clinical Data Management

    CTI’s Clinical Data Management (CDM) team has a study-specific approach that begins with a careful review of study specifications, client preferences/history, data to be collected, and technologies available. Our CDM team then provides guidance to sponsors on the most appropriate method of data collection to best serve the needs of the study, sites, and project team. We offer multiple validated, industry-leading technology platforms. Our team has expertise in numerous software applications and can recommend one that is right for each study and budget. Our team provides a great degree of transparency to the sponsor regarding study metrics and study status, regardless of the platform used. The CTI CDM team is dedicated, responsive, and provides an elevated degree of flexibility. Our CDM team offers comprehensive clinical data management services including:

    • Case report form (CRF)/ Electronic case report form (eCRF) design
    • Database design and implementation
    • Data validation, review, and cleaning
    • Medical coding
    • Comprehensive management of data from third-party electronic data vendors
    • Data consolidation, migration, and conversion including Clinical Data Interchange Standards Consortium (CDISC) and Study Data Tabulation Model (SDTM) transformations
    • Consultation and data management strategies, systems, procedures, and metrics

    Biostatistics

    CTI Biostatisticians are involved in the entire lifecycle of drug development from regulatory pathway design through medical writing. Our Biostatisticians interact on a daily basis with our teams in project managers, clinical monitors, data management, safety, regulatory, and medical affairs. These interactions ensure that data are captured appropriately and consistently across all investigative centers. These interactions also ensure statistical questions that arise are answered in a timely manner, and statistical analyses performed and inferences made are clinically relevant. Our Biostatistics team is flexible, with fast turn-around times on ad hoc analysis and data transfer requests, in addition to having the ability to work with a variety of file types. Specific services include the following:

    • Protocol development
    • Case report form (CRF) and electronic case report form (eCRF) review
    • Statistical analysis plan (SAP) development
    • Statistical programming
    • Randomization
    • Statistical reports
    • Data and Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC) participation