We begin with the end in mind – quality data

At Insight Clinical Consulting our team of experts has longstanding experience providing customized data management solutions to emerging to mid-sized biotechnology companies, across all phases and therapeutic areas of clinical trials. We begin with the final deliverable in mind, and manage a process designed to deliver an error-free, valid, and statistically sound database because we know how critical timely, high-quality data is to driving outcomes you can trust. It is with this understanding that we carefully undertake your in-house and out-sourced data management activities for ongoing clinical trials, supported by targeted SOPs and adhering to regulatory standards to meet study objectives, on time and on budget.

Our Clinical Data Management Capabilities consist of:

  • Creating and/or reviewing data management documentation, including but not limited to:
    • Data management plans
    • Data handling guidelines
    • Data quality review plans
    • CRF completion guidelines
    • Annotated CRFs
    • Data transfer agreements
    • External data reconciliations
    • Database quality control/audit plans
  • Driving CRF development in accordance with CDASH standards
  • Providing CDASH, CDISC, 21 CFR Part 11, and GCDMP data management expertise
  • Overseeing successful database development and execution of database UAT
  • Cleaning and locking data in support of interim analyses and submissions
  • Medical Coding using MedDRA and WHODrug
  • Developing and/or reviewing Standard Operating Procedures (SOPs) for in-house and out-sourced data management
  • Participating in vendor evaluations and qualifications
  • Rescuing Studies

Clinical Data Management Platforms:

With expertise across a variety of clinical data management (CDM) platforms, we can help you find the best fit for your study. We have clinical database programming experience with leading EDC platforms. We are a Medidata Services Partner accredited in Medidata Rave® EDC, and we also conduct studies in other CDM platforms, including:

  • Medidata Rave®
  • Oracle InFormTM
  • DATATRAK ONETM
  • Medrio
  • Clinical Studio
  • Bioclinica Express
  • iDataFax®
  • IBM Clinical Development
  • ClinCapture

Contact us today to learn how Insight Clinical Consulting can help with all your clinical data management needs.