ClinPro Trials™ Launches Independent Clinical Compliance Assessment for Trials Still in Progress
ClinPro Trials™ Launches Independent Clinical Compliance Assessment for Trials Still in Progress
The Compliance CRO™ gives sponsors, boards, and investors an independent view of mid-trial execution while there is still time to act.
SAN FRANCISCO--(BUSINESS WIRE)--ClinPro Trials (CPT), The Compliance CRO™, today announced its independent clinical compliance assessment service for biopharmaceutical sponsors, boards, and investors.
ClinPro Trials launches independent clinical compliance assessment for trials still in progress — giving sponsors, boards, and investors an independent view while there is still time to act.
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While sponsors routinely delegate trial activities to operational CROs, ultimate responsibility for data integrity remains with the sponsor. Operational reporting often tracks milestone progress without providing an independent view of the compliance state across the entire trial. If compliance gaps are only discovered during major milestones, regulatory reviews, or inspections, the opportunity to correct them may be significantly reduced—resulting in regulatory delays, remediation costs, and lost enterprise value.
“The first independent look across the whole trial should not come from the regulator,” said Monita Dukhia, Founder of CPT. “The time to understand how the trial is actually being conducted is while it is still running—when the people, records, and opportunity to act are still present.”
Independent Assessment Across the Trial
CPT assesses clinical trial execution while trials are still in progress against Good Clinical Practice (GCP) and applicable regulatory requirements. Unlike audits that may focus on individual sites, vendors, or defined audit scopes, CPT examines the broader delegated trial environment and the interfaces between organizations. CPT does not run trials or replace a sponsor’s internal QA team; instead, it complements existing programs to give senior management, boards, and appropriately authorized investors an independent view of execution risk. CPT assessments for boards and investors require sponsor authorization to access sponsor-controlled trial information.
About ClinPro Trials™
ClinPro Trials™, The Compliance CRO™, provides independent clinical compliance assessments to biopharmaceutical sponsors, boards, and investors while clinical trials are in progress. CPT is led by Monita Dukhia, who brings more than 30 years of global biopharmaceutical experience in clinical development, regulatory compliance, and inspection readiness.
Contacts
Media & Business Inquiries:
Monita Dukhia
Founder and Chief Executive Officer
ClinPro Trials™ The Compliance CRO™
mdukhia@clinprotrials.net
Website: clinprotrials.net
