Novella Clinical’s Medical Monitoring department employs a core group of licensed and board-certified, in-house clinical research physicians supplemented with a network of physician consultants who provide specific therapeutic expertise. This combination of highly skilled physicians offers a cost-effective approach to day-to-day trial activities, as well as the therapeutic expertise of practicing research physicians with state-of-the-art training. Whether the sponsor requests initial study design, protocol development, full study execution or select medical task assistance, our team tailors each program’s medical needs with the desired medical support.

Our medical monitoring services include:

 

  • Protocol development and consulting
  • Therapeutic consulting
  • Medical review of informed consent
    and CRF design
  • Development of individual study medical
    monitoring plans
  • Investigator brochure development
  • Site selection and enrollment enhancement solutions
  • Key opinion leader network development
  • Scientific and medical support for project management teams and sites
  • Laboratory data review
  • Medical data coding and review
  • 24-hour on call medical monitoring for protocol queries and site support, medical/safety issues
  • Regulatory agency support and interface
  • End of study tables and listings review and scientific manuscript drafting/review