Source Data Review
Direct verification of trial data at research sites, ensuring absolute protocol adherence and data integrity for Phase I-IV studies.
GCP Audit & Readiness
Comprehensive regulatory compliance audits, essential document review, and FDA inspection readiness for all clinical trials.
Northeast Field Teams
Rapid deployment of certified CRA field personnel to medical centers and research laboratories across New York and the surrounding region.
Safeguarding Data Integrity, Ensuring Regulatory Compliance
Every audit, every verification, every report is executed with methodical precision, upholding the highest standards of GCP and ICH guidelines.
Methodical Monitoring From Start to Finish
Pre-Study Site Evaluation
Routine Monitoring Visits
Issue Resolution & Reporting
Close-Out & Archival
Initial assessment of site capabilities, investigator qualifications, and facility readiness for trial initiation.
Scheduled on-site visits for source data verification, regulatory binder review, and protocol adherence checks.
Final site close-out visits, essential document reconciliation, and TMF archival sign-off.
Identification and resolution of protocol deviations, followed by concise, actionable reports for sponsors.
Connect with our team to tailor an oversight plan that ensures your study's integrity and compliance.