1125 Boone Aire Road,
Florence, KY 41042
Call (859) 426-5035

LBR Project Management Services

Our Experienced Project Managers Provide:

  • Oversight and Management of Phase 2 - 4 Clinical Studies
  • Budget and Time Management
  • Vendor and Resource Management
  • Communications and Rapid Issues Resolution
  • Staff Training
  • Study Documentation

To achieve successful on-time and on-budget execution and delivery of studies requires expert management by experienced project managers. At LBR, we have five project managers who are highly skilled, senior level personnel.

Our project managers will oversee vendors and the LBR staff assigned to the project. They will ensure that written procedures needed for all studies are prepared and that staff members are properly trained on the project. Our project managers are responsible for all communications with the sponsor and for oversight of timelines and meeting sponsor expectations. Study documentation and tracking tools will be reviewed and identification and resolution of issues will be handled in a timely manner.

Full project management services of clinical studies are available for Phase 2 - 4 studies and include start up, on-study and finalization activities.

Project Management Activities

  • Investigator meeting planning and set up
  • Identification and qualification of study sites
  • Monitoring of pre-study qualification visits
  • Preparation and collection of required site regulatory documents
  • Investigator contract negotiation
  • Review of ICFs and advertising
  • Monitoring of initiation visits
  • Enrollment tracking
  • Central IRB filings
  • Investigator and IRB payments
  • Writing protocol amendments and ICFs
  • Monitoring of interim visits
  • Writing safety narratives
  • Maintenance of the trial master file
  • Quality Control reviews at clinical sites
  • Monitoring of close-out visits
  • Preparation for site audits
  • Review of data listings
Investigator Contract Negotiation