Performance, Excellence, & Efficiency in Research

 

Our Services

 

Institutions

  • Development of Human Research Protection Programs
  • Integration of HRPP Components
  • Consultation for:
    • Conflict of Interest (COI) Committees/COI Policies
    • Institutional Review Boards (IRBs)
    • HIPAA/Privacy Boards
    • Grants Management/Sponsored Programs
    • Research Billing
    • Radioactive Drug Research Committees (RDRCs)
    • Embryonic Stem Cell Oversight Committees (ESCROs)
    • Compliance Oversight Programs
    • Institutional Officials - Enhancing the ethical conduct of research
  • Education and Training for Investigators and Administrators
  • Develop an Educational and Training Conference
  • Compliance Oversight: Review of IRBs or Research Teams

 

Investigators

  • Implementation of Quality Systems for Conduct of Research by Investigators​
  • Consultation on Ethical Design of Studies
  • Consultation on Interactions with FDA
  • Staff Training and Development
  • Development of Case Report Forms (CRFs) for Investigator-Initiated Studies
  • Drug or Device Accountability
  • Monitoring of Studies for Sponsor-Investigators
  • Preparation for FDA Audits
  • Responses to FDA 483 Reports or Warning Letters

 

IRBs

  • Enhancement of the Quality and Efficiency of IRB Review
  • Consultation on Organizational Structure
  • Staff Development
  • Education and Training
  • Evaluation of Compliance with Federal Regulations
  • Evaluation or Drafting of Standard Operating Procedures
  • Responses to FDA audits of IRBs
  • ​Responses to OHRP Compliance Inquiries
  • Temp Services for IRB Director & Associate Director Positions

 

Sponsors

  • Medical Writing/Drafting Protocols
  • Consultation on Ethical Design of Studies
  • Consultation on Interacting with FDA
  • Development of Case Report Forms
  • Assessment and Development of New Sites
  • Site Initiation Visits for Investigators
  • Education and Training of Investigators/GCP Training
  • Enhancing Capture of Data and Endpoints
  • Site Monitoring
  • Preparation for Audit and Clean-up of Data