Site Evaluation Process

Through extensive evaluation, we initially accept only a fraction of applicant sites into our network. All ISS-referred sites meet our quality benchmarks, including successful patient enrollment results, significant trial experience, trained full-time staff, rapid turnaround of documents, and excellent FDA audit histories. Our three-step evaluation process is as follows:

Preliminary Screening

All research sites in our network have gone through an extensive screening process in which they are rated based on several criteria, such as:
  • Site experience conducting phase I-IV clinical trials across several therapeutic areas.
  • Fully trained, certified coordinators and investigators with research experience in their medical specialties; supported by administrative, recruitment and regulatory staff.
  • Access to substantial disease patient, treatment-naïve, and minority populations.
  • Established SOPs supporting rapid contract and budget negotiation time.
  • 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 the most appropriate sites are quickly identified for each study as we:
  1. Define your site needs and protocol requirements
  2. Distribute, collect, and review sites identification documents
  3. Rapidly submit the most qualified investigators within your designated time frame
  4. Facilitate direct connections with site personnel for final site selection and study-related activities
Upon submission, the sponsor communicates directly with the site for all selection activities and chooses investigators for study participation. ISS does not intervene in budget/contract negotiations and investigator payment. Because research sites contract with ISS to identify appropriate trials based on their clinical practice and research experience, we do not charge the sponsor for our services.

Ongoing Monitoring

ISS 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.