Site Evaluation

Through extensive site evaluation we help your organization assess existing sites or select new applicant sites in order to meet your clinical trials requirements. CiPharma assesses skill areas, quality bench marks, trial experience, patient enrollment processes, staff capability, training requirements, documentation standards and processes.

Our three-step evaluation process is as follows:

Preliminary Screening

Research sites undergo an extensive screening process in which they are assessed and rated based on several criteria:

  • Site experience of conducting phase I-IV clinical trials across relevant therapeutic areas.
  • Training and research experience of their medical specialties; support by administrative, recruitment and regulatory staff.
  • Access to substantial disease patient, treatment naive, and minority populations.
  • Availability of quality & compliance processes and documentation including  SOPs, Work Instructions etc.
  • On-site technology infrastructure including high-speed Internet, EDC experience, and access to pharmacy and lab facilities.
  • Comprehensive background checks including CV reviews, state medical board and FDA audit checks with thorough review of all 483s.

Study Pre-qualification

Our pre-qualification process ensures that sites are  rapidly assessed and prepared for the study, we work with them to:

  1. Define your site needs and protocol requirements
  2. Distribute, collect, and review sites identification documents
  3. Identify and ready the most qualified investigators within your designated time frame
  4. Facilitate direct connections with site personnel for final site selection and study-related activities

Ongoing Monitoring

CiPharma continually evaluates site performance through our internal data tracking systems. We monitor the quality, accuracy, and speed of site communications; enrollment statistics; and sponsor/CRO feedback.

Periodically, our staff will check in with you for site selection confirmation, enrollment data, and investigator performance information. By assessing issues such as patient recruitment and retention, compliance, and document turnaround times, we can continue to ensure overall site quality.