Avania clinical safety management specializes in the distillation and dissemination of the information you need to design an efficient program and bring your product to market.

During the conduct of trials, investigators and their colleagues have questions that require medical training to answer. These questions may involve interpreting protocol details, ensuring consistency regarding how medical care and protocol assessments are delivered to patients, addressing immediate concerns about safety issues, and more. Avania can provide an M.D. and support staff who will serve as a single point of medical knowledge to ensure the protocol is executed as intended and sites conduct the trial in harmony.

Avania offers medical monitoring services directly or can integrate with and support a medical monitor you provide.

Avania‚Äôs safety management and study oversight committees are comprised of therapeutically aligned experts. These committees support the integrity of clinical study data by conducting an unbiased and independent review of endpoints and safety data to ensure objectivity.

Our safety management services include:

  • Medical safety review
  • Review of all serious adverse events (SAEs) and reporting of unanticipated device effects (UADEs) and suspected unanticipated serious adverse events (SUSARs), as required
  • Safety narratives
  • Regulatory dictionary coding, report preparation, and submission
  • Interim safety listings and reports
  • Preparation of listings for annual and study reports

At Avania, the Study Oversight Committee forms and manages Clinical Events Committees (CECs) and Data Monitoring Committees (DMCs).

Member selection and qualification

  • Identify CEC members, with access to a global pool of board-certified physicians through our physician network
  • Manage member contracts and payments
  • Prepare HCP reporting for sponsors

Charter and process development

  • Develop the CEC charter, in collaboration with sponsors
  • Design and set up the optimal CEC processes for each trial based on the clinical protocol and charter
  • Collaborate with sponsors and CEC members to identify appropriate data required for adjudication

Committee oversight and management

  • Coordinate meetings, including agendas, logistics, hosting, and minutes
  • Collect and maintain data related to clinical events
  • Review and record clinical events and conduct adjudication with CEC members
  • Provide CEC adjudicated results as part of interim and final statistical analyses
  • Serve as primary liaison between sponsor and committee, as required

Member selection and qualification

  • Identify DMC members from a pool of board-certified physicians and key opinion leaders through our physician network
  • Administer member contracts
  • Prepare HCP reporting for sponsors

Charter and process development

  • Establish a written charter, with well-defined standard operating procedures for committee operations, which are in accordance with FDA guidance, EMA guidelines, and ICH guidelines
  • Collaborate with sponsors to document predefined statistical stopping boundaries in the charter
  • Engage the DMC in identifying appropriate data required for safety review

Committee oversight and management

  • Coordinate meetings, including agendas, logistics, hosting, and minutes of appropriate sessions
  • Provide current data reports for periodic safety reviews and interim analyses with expert biostatistician guidance
  • Facilitate communications between DMC and sponsor
  • Administer member payments
  • Serve as primary liaison between sponsor and committee, as required