Our success is measured by the measurable outcomes we help our clients achieve. Divergent S.P.E.E.D. has supported sponsors, CROs, and research sites in reaching critical milestones with confidence.
Audit Readiness Improvement:
Helped a mid-size oncology sponsor reduce audit findings by 45% through proactive quality oversight and targeted corrective action planning.
Regulatory Compliance:
Partnered with a biotech client to implement a GCP training and compliance framework that achieved 100% inspection readiness for an FDA audit.
Operational Efficiency:
Streamlined cross-functional quality oversight for a global Phase III trial, resulting in a 30% faster issue resolution rate and improved documentation integrity.
"As a global CRO managing complex, multi-country trials, we partnered with Divergent S.P.E.E.D. to strengthen our audit readiness and vendor oversight framework. Their team led a comprehensive quality systems review spanning the U.S., EU, and APAC regions. Within three months, Divergent S.P.E.E.D. helped us streamline processes across 20+
"As a global CRO managing complex, multi-country trials, we partnered with Divergent S.P.E.E.D. to strengthen our audit readiness and vendor oversight framework. Their team led a comprehensive quality systems review spanning the U.S., EU, and APAC regions. Within three months, Divergent S.P.E.E.D. helped us streamline processes across 20+ studies, resulting in a 45% reduction in protocol deviations, 30% faster site activation, and zero critical findings during our sponsor audit. Their precision, professionalism, and hands-on approach gave our teams confidence and ensured compliance at every stage. Divergent S.P.E.E.D. is now an essential partner in maintaining global clinical quality excellence."
— VP, Global Clinical Operations, International CRO
"As a mid-size CRO expanding into EU markets, we needed expert oversight to strengthen our audit program and vendor compliance. Divergent S.P.E.E.D. conducted a full-scope audit across five vendor partners and identified operational risks that had gone unnoticed. Within six weeks, their corrective and preventive action (CAPA) plan reduced
"As a mid-size CRO expanding into EU markets, we needed expert oversight to strengthen our audit program and vendor compliance. Divergent S.P.E.E.D. conducted a full-scope audit across five vendor partners and identified operational risks that had gone unnoticed. Within six weeks, their corrective and preventive action (CAPA) plan reduced repeat findings by 70%, increased audit efficiency by 45%, and streamlined communication between our QA and operations teams. Their precision, professionalism, and deep regulatory insight gave our clients new confidence in our capabilities."
— VP, Quality Assurance, Contract Research Organization (CRO)
"Before partnering with Divergent S.P.E.E.D., our sponsor audit program was reactive, not proactive. Their consulting team redesigned our global inspection-readiness process — including SOP harmonization and mock FDA and MHRA inspections — that improved compliance metrics by 65% within one quarter. They helped us implement a sustainable q
"Before partnering with Divergent S.P.E.E.D., our sponsor audit program was reactive, not proactive. Their consulting team redesigned our global inspection-readiness process — including SOP harmonization and mock FDA and MHRA inspections — that improved compliance metrics by 65% within one quarter. They helped us implement a sustainable quality oversight framework that decreased protocol deviations by 50% and ensured every site was inspection-ready at all times. Divergent S.P.E.E.D. has set a new benchmark for quality consulting."
— Executive Director, Clinical Quality & Compliance, U.S.-Based Pharma Sponsor
"As a growing biotech startup, we struggled with maintaining GCP compliance and audit readiness across our early-phase clinical programs. Divergent S.P.E.E.D. stepped in and completely transformed our quality systems. Within three months, they conducted a comprehensive audit readiness assessment, identified 47 key process gaps, and implem
"As a growing biotech startup, we struggled with maintaining GCP compliance and audit readiness across our early-phase clinical programs. Divergent S.P.E.E.D. stepped in and completely transformed our quality systems. Within three months, they conducted a comprehensive audit readiness assessment, identified 47 key process gaps, and implemented corrective actions that improved our inspection preparedness by 85%.
Their expertise reduced our audit findings by 60%, accelerated our SOP alignment timeline by 40%, and helped us achieve full regulatory compliance ahead of schedule. Thanks to their hands-on consulting and precision-driven approach, we entered our Phase II study with complete confidence — something we couldn’t have achieved without their support. Divergent S.P.E.E.D. doesn’t just consult; they empower success.”
— Director of Clinical Operations, Global Biotech Partner
"Working with Divergent S.P.E.E.D. transformed the way we manage our international trials. Their audit and consulting team led a comprehensive global compliance review across the U.S., U.K., and Asia, identifying key regulatory gaps and training over 120 team members. Within four months, our inspection readiness score increased by 92%, an
"Working with Divergent S.P.E.E.D. transformed the way we manage our international trials. Their audit and consulting team led a comprehensive global compliance review across the U.S., U.K., and Asia, identifying key regulatory gaps and training over 120 team members. Within four months, our inspection readiness score increased by 92%, and our study start-up timelines improved by 38%. Their ‘S.P.E.E.D.’ approach — Strategy, Precision, Excellence, Execution, and Delivery — truly delivers measurable results."
— Head of Clinical Operations, Global Biotech Company
"Partnering with Divergent S.P.E.E.D. was a turning point for our EU and UK clinical programs. As a growing biotech navigating multiple regulatory frameworks, we struggled with consistent documentation, vendor oversight, and MHRA readiness. The Divergent S.P.E.E.D. team conducted a full operational audit across three ongoing oncology tria
"Partnering with Divergent S.P.E.E.D. was a turning point for our EU and UK clinical programs. As a growing biotech navigating multiple regulatory frameworks, we struggled with consistent documentation, vendor oversight, and MHRA readiness. The Divergent S.P.E.E.D. team conducted a full operational audit across three ongoing oncology trials and implemented a targeted CAPA and training program. Within just eight weeks, we achieved a 60% reduction in audit findings, 35% faster document turnaround, and 100% MHRA inspection readiness. Their global expertise, clear communication, and hands-on support gave us the structure and confidence we needed to move forward successfully."
— Director of Clinical Quality, Mid-Sized Biotech (EU/UK)
"As a mid-sized CRO expanding into global markets, we needed expert guidance to strengthen our audit program and vendor compliance. Divergent S.P.E.E.D. conducted a full audit across five vendor partners and identified operational risks we had overlooked. Within six weeks, their CAPA plan reduced repeat audit findings by 70%, increased mo
"As a mid-sized CRO expanding into global markets, we needed expert guidance to strengthen our audit program and vendor compliance. Divergent S.P.E.E.D. conducted a full audit across five vendor partners and identified operational risks we had overlooked. Within six weeks, their CAPA plan reduced repeat audit findings by 70%, increased monitoring efficiency by 45%, and improved communication between QA and operational teams. Their precision, professionalism, and regulatory expertise have become an invaluable part of our growth strategy."
— VP, Quality Assurance, Contract Research Organization (CRO)
"As a small biotech launching our first Phase II oncology trial, we struggled with regulatory compliance and SOP development. Divergent S.P.E.E.D. guided us through protocol review, risk assessments, and training for our team. Within three months, we achieved 100% inspection readiness, reduced documentation errors by 60%, and accelerated
"As a small biotech launching our first Phase II oncology trial, we struggled with regulatory compliance and SOP development. Divergent S.P.E.E.D. guided us through protocol review, risk assessments, and training for our team. Within three months, we achieved 100% inspection readiness, reduced documentation errors by 60%, and accelerated site activation by 35%. Their hands-on support and strategic insights gave us the confidence to navigate complex regulatory requirements and launch our trial successfully."
— Director of Clinical Operations, Early-Stage Pharma Startup
"Managing multi-region clinical trials across the U.S., EU, and Asia was a challenge for our global biotech. Divergent S.P.E.E.D. provided a comprehensive audit and consulting program, including vendor oversight, TMF/eTMF reviews, and mock inspections. Within four months, they reduced protocol deviations by 50%, improved site start-up tim
"Managing multi-region clinical trials across the U.S., EU, and Asia was a challenge for our global biotech. Divergent S.P.E.E.D. provided a comprehensive audit and consulting program, including vendor oversight, TMF/eTMF reviews, and mock inspections. Within four months, they reduced protocol deviations by 50%, improved site start-up timelines by 40%, and ensured readiness for FDA, EMA, and MHRA inspections. Their expertise, responsiveness, and precision-driven approach set a new standard for clinical quality in our organization."
— Head of Clinical Operations, Global Biotech Company
Problem:
A mid-sized CRO was managing multiple international trials but struggled with inconsistent audit readiness and vendor compliance across sites in the U.S., EU, and Asia. Delays in site activation and repeated audit findings were impacting timelines and sponsor confidence.
Action:
Divergent S.P.E.E.D. conducted a full operational audit, including vendor oversight, SOP gap analysis, and TMF/eTMF review. Implemented a corrective and preventive action (CAPA) plan and trained staff on compliance standards and inspection readiness.
Result:
Problem:
A small biotech launching its first Phase II oncology trial lacked standardized SOPs and regulatory compliance processes, causing delays in IRB submissions and site start-up.
Action:
Divergent S.P.E.E.D. provided step-by-step protocol review, risk assessments, and SOP development. Conducted team training on GCP, TMF management, and FDA/EMA requirements.
Result:
Problem:
A global biotech running trials across the U.S., EU, and UK faced difficulty ensuring consistent compliance and risk management across multiple sites, leading to protocol deviations and slow enrollment.
Action:
Divergent S.P.E.E.D. implemented global audit oversight, conducted mock inspections, reviewed TMFs, and trained site and sponsor teams on regulatory standards and risk mitigation strategies.
Result:
Problem:
A mid-sized biotech in the EU struggled with incomplete Trial Master Files (TMFs) and inconsistent documentation across five ongoing Phase II oncology trials, raising concerns about regulatory inspection readiness.
Action:
Divergent S.P.E.E.D. performed comprehensive TMF/eTMF audits, identified documentation gaps, implemented corrective actions, and trained staff on consistent recordkeeping and inspection preparedness.
Result:
Problem:
A UK-based CRO managing multi-country trials lacked a robust system for vendor oversight, leading to inconsistent performance, missed milestones, and potential regulatory risk.
Action:
Divergent S.P.E.E.D. implemented a global vendor audit program, created performance KPIs, and provided targeted coaching to improve adherence to ICH/GCP standards.
Result:
Problem:
A multinational pharma sponsor was preparing for simultaneous FDA, EMA, and MHRA inspections across multiple Phase III trials but faced gaps in risk assessment, SOP compliance, and staff readiness.
Action:
Divergent S.P.E.E.D. conducted mock inspections, risk assessments, and compliance gap analysis, then developed corrective action plans and trained teams globally on regulatory expectations.
Result:
Divergent S.P.E.E.D.
© 2025 Divergent S.P.E.E.D. – Divergent Clinical Quality Solutions
Global Audit & Consulting Excellence | Upholding Integrity, Innovation & Compliance
Email: partnership@DivergentSpeed.com | www.divergentspeed.com
Divergent S.P.E.E.D.
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