Clinical Trials site management

IBI can provide Investigative Sites with a myriad of services to assist in the establishment of a new clinical research component to an existing practice as well as provide services that can strengthen and increase the core capabilities of the Site and personnel. Rather than trying to sell you services you may not need, all of our services are customized specifically to the needs of the Site.

Although all of our services are customized to the specific needs of the Site, the following is a representative sample of solutions we have provided in the past.

Trial Management

• Staffing with trained and experienced clinical research coordinators
• Subject Recruitment Strategies
• Data Management
• Independent protocol audits for QA and training purposes
• Budget negotiations

Site Management

• Site specific S tandard O perating P rocedures (SOP's)
• Quality Assurance
• Audit Services
• FDA inspection preparation

Site Business Development and Promotion

• Notification of upcoming research trials and opportunities
• Marketing and business development of your site and its capabilities

Education

• On site developmental training for investigators and staff
• On site facility assessment
• Customized Programs in:
  • Working with/interacting with Institutional Review Boards (IRB)
  • Understanding and complying with FDA, HHS and HIPAA regulations
  • Effective subject consent processes
  • Ethics/Protection of human subjects
  • Current industry standards (GCP, GLP, GMP)
  • Regulatory document preparation and maintenance