Ensure Clinical Trial Success with Compliant Oversight
Ensure Clinical Trial Success with Compliant Oversight
Guarantee protocol compliance and meet ICH/GCP regulations with independent, specialized oversight that protects your trial integrity.
Compliant with FDA 21 CFR Part 312 Subpart D requirements for sponsor oversight
Guarantee protocol compliance and meet ICH/GCP regulations with independent, specialized oversight that protects your trial integrity.
Compliant with FDA 21 CFR Part 312 Subpart D requirements for sponsor oversight
"Pristine's hands-on oversight approach and regulatory expertise helped us navigate complex compliance requirements. Their team's meticulous monitoring during site visits ensured our Phase III trial maintained the highest standards of data integrity and patient safety."
"Pristine's hands-on oversight approach and regulatory expertise helped us navigate complex compliance requirements. Their team's meticulous monitoring during site visits ensured our Phase III trial maintained the highest standards of data integrity and patient safety."
-VP of Clinical Operations, Leading Biotech Company
Next-Level Clinical Trials
Next-Level Clinical Trials
Full Trial Oversight
Full Trial Oversight
Meticulous monitoring at every stage: PSV, SIV, IMV & COV. Real-time recommendations to ensure protocol compliance and data integrity.
Hands-On Approach
Hands-On Approach
Direct involvement during study startup, maintenance, and closeout. Accompanied site visits ensure rigorous oversight throughout the trial lifecycle.
Risk Prevention
Risk Prevention
Proactive identification, engagement, and resolution of compliance challenges before they impact your trial's success or patient safety.
What Clinical Operations Leaders Say
What Clinical Operations Leaders Say
"Pristine's oversight team provided invaluable support during our multi-site Phase III trial. Their accompanied site visits and real-time monitoring helped us maintain perfect ICH/GCP compliance across all locations. They caught potential issues before they became problems."
"Pristine's oversight team provided invaluable support during our multi-site Phase III trial. Their accompanied site visits and real-time monitoring helped us maintain perfect ICH/GCP compliance across all locations. They caught potential issues before they became problems."
-Clinical Operations Director, Top 10 Pharma Company
"Having Pristine's hands-on oversight from study startup through closeout gave us complete confidence in our data integrity and regulatory compliance. Their expertise in FDA requirements was evident in every interaction and recommendation."
"Having Pristine's hands-on oversight from study startup through closeout gave us complete confidence in our data integrity and regulatory compliance. Their expertise in FDA requirements was evident in every interaction and recommendation."
-Head of Clinical Development, Emerging Biotech
Download The Clinical Excellence Blueprint
Download The Clinical Excellence Blueprint
Learn how to accelerate science through clinical trial operational excellence
Learn how to accelerate science through clinical trial operational excellence