The importance of investigational-site selection for trial success
Choosing the right site affects both the quality of clinical data and regulatory compliance. Sites experienced in medical-device trials and familiar with ISO 14155 significantly reduce the risk of procedural errors. Equally important is a study team with documented MDR-project experience, ready to operate quality-management systems and respond to adverse events.
Formal and technical requirements for investigational sites
Every site must meet at least the following infrastructure and staff standards:
- certified medical and laboratory equipment,
- access to EDC systems and full GCP compliance,
- a Principal Investigator with clinical experience,
- procedures for data management and patient safety (SAE/SUSAR),
- a quality system aligned with ISO 14155—especially for class III device studies.
Assessing patient availability during site selection
Patient population is the key to successful recruitment. The evaluation should include:
- epidemiological data and local incidence statistics,
- recruitment history (screening/enrolment rates),
- access to niche groups, e.g. for speciality studies,
- completion of feasibility questionnaires confirming that the population matches protocol assumptions.
Lack of access to suitable patients leads to delays, higher costs, and the need to expand the study to additional locations.
Technical and logistical verification of investigational sites
Beyond staff and patient access, operational readiness is critical:
- compliance with Trial Master File documentation requirements,
- validated diagnostic procedures (especially for IVD studies),
- facilities for biobanking biological samples,
- IT systems that meet data-security requirements,
- preparedness for audits by notified bodies and sponsors.
The value of prior collaboration and site reputation
Reviewing past cooperation helps assess:
- timeliness (e.g. FPI/LPO),
- document quality (CRF, monitoring reports),
- results of external and internal audits,
- adherence to schedules and inspection plans.
Sites with numerous major findings may be excluded from the project. A positive collaboration history increases sponsor confidence and speeds up regulatory approval.
The role of feasibility analysis in site selection
Feasibility assessment is an integral part of the selection process. It analyses site-protocol fit, population availability, technical resources, and staff experience. The assessment produces a site-scoring matrix that ranks locations by recruitment potential, ISO 14155 compliance, and project risks.
Typical reasons for excluding investigational sites
Sites may be rejected due to:
- lack of a population meeting inclusion criteria,
- no ethics-committee approval,
- negative audit history or non-implementation of GCP,
- failure to meet MDR requirements for medical devices,
- operational non-compliance with ISO 14155.
All these factors should be documented in standard site-selection reports.
How Pure Clinical supports investigational-site selection
Pure Clinical assists sponsors and CROs in site selection through:
- independent audits of clinical infrastructure and documentation,
- analysis of patient populations and epidemiological data,
- verification of compliance with MDR, GCP, and ISO 14155,
- development of scoring matrices and feasibility reports,
- recommendations on managing recruitment and operational risks.
Our work minimises the risk of choosing an unsuitable site and increases the efficiency of trial execution.
FAQ
How does site selection influence regulatory acceptance of a clinical trial?
Can operational risk at a site be predicted using historical data?
How important is IT system interoperability at a site for multi-center clinical trials?
System interoperability—including EDC, eTMF, and data security platforms—ensures smooth information flow among sites, CROs, and sponsors. Lack of compliance with international standards (e.g., 21 CFR Part 11) can result in reporting errors and reduce the analytical value of collected data.