PRN – Services

PRN Pharmaceutical Research Network, LLC provides a full range of consulting and trial management services, from project conception through completion. PRN specializes in building unique teams of seasoned professionals, customized to meet your needs.

Project Foundations

  • Document development
    • Design and write protocols
    • Develop customized Electronic Data Capture (EDC) forms
      PRN collaborates with Celes Systems GmbH, based in Darmstadt Germany, a company specializing in easily customized, ophthalmic-specific EDC services. Named Cirrus, it provides full integration with IWRS, financial and ePRO services.
    • Create customized source documents
    • Craft customized tools to ensure careful project management
    • Paper data capture forms
  • Planning
    • Goal directed clinical plans
    • Economical and efficient regulatory plans
    • Customized tools to ensure careful project management
    • Backup plans for overlapping management of every study
  • Expert resources
    • Investigators from PRN’s database of proven, trusted sites
    • Access to packaging CRO’s
    • Introduction to life-science insurance experts
  • Qualified team
    • Professional, mature and friendly ophthalmic CRAs and project managers with established site relationships
    • Professional, experienced pharmacovigilance team
    • Board certified ophthalmologist as Medical Monitor
  • Client IT security assessment

Initiation

  • Site feasibility assessments
  • Customized site training for both new and seasoned investigational sites
  • Applications to Competent Authorities and Ethics Committees
  • Select the best central Institutional Review Board
  • Investigator Meetings planning and management
  • Contract management with sites and vendors

Management

  • High quality study management and monitoring
  • Communications between sites, vendors and sponsors
  • Troubleshooting site and sponsor questions and issues
  • Careful pharmacovigilance
  • Vendor and site payments
  • Flexible milestone payment schedule
  • Clinical safety review

Completion

  • Site close-out and drug accountability
  • Data management by ophthalmic experts
  • Biostatistical analysis by statisticians who understand ophthalmology and regulatory requirements
  • Precise Clinical Study Reports
  • Manuscript development and management to publication
  • Site audit capacity