At Divergent S.P.E.E.D. – Divergent Clinical Quality Solutions, we deliver comprehensive global auditing and consulting solutions that empower organizations to meet regulatory standards, optimize performance, and advance ethical research. Our approach blends innovation, precision, and integrity, ensuring every client receives tailored, actionable strategies aligned with global compliance expectations.
AUDITING SERVICES
We provide independent, in-depth audits designed to ensure regulatory compliance, data integrity, and operational excellence.
- Clinical Trial Audits (All Phases, Global) – Evaluate study conduct, documentation, and data integrity across the U.S., EU, UK, and Asia.
- Vendor & CRO Oversight – Assess vendor performance, contractual obligations, and adherence to ICH/GCP.
- TMF / eTMF Audits & Readiness Reviews – Identify documentation gaps, ensure inspection readiness, and streamline TMF management.
- Mock Regulatory Inspections – Prepare teams for FDA, EMA, MHRA, and other authority audits through realistic pre-inspection simulations.
- Corrective and Preventive Action (CAPA) Follow-Up – Provide actionable recommendations and verification of implementation.
CONSULTING SERVICES
Our consulting solutions drive operational efficiency, enhance compliance, and foster sustainable clinical excellence.
- Regulatory Compliance Consulting – Guidance across FDA, EMA, MHRA, PMDA, and ICH/GCP frameworks.
- SOP & Policy Development – Creation and review of SOPs, policies, and work instructions aligned with regulatory and operational best practices.
- Process Optimization & Workflow Assessment – Identify bottlenecks, refine processes, and enhance communication between functions and study sites.
- Protocol Development & Review – Ensure study protocols and informed consent documents meet scientific and ethical standards.
- Risk Assessment & Mitigation Planning – Evaluate study or operational risks and design tailored mitigation strategies.
- Feasibility & Endpoint Validation – Assess the viability and clinical relevance of endpoints and trial outcomes to support regulatory acceptance.
STAKEHOLDER & PATIENT ENGAGEMENT
We believe patient and stakeholder perspectives drive better research outcomes. Divergent S.P.E.E.D. bridges communication between patients, industry, and research teams to enhance transparency, trust, and inclusion.
- Incorporate patient insights into study design to ensure feasibility and relevance.
- Collaborate with sponsors and sites to develop effective recruitment and retention strategies.
- Provide educational materials that improve participant understanding and engagement.
Training & Development
We empower clinical research professionals with targeted, practical training designed to elevate quality and compliance standards across all levels of operation.
- Good Clinical Practice (GCP) & Regulatory Training
- Audit Readiness & Inspection Preparation
- Risk-Based Monitoring & Oversight
- Vendor Oversight & KPI Management
- TMF / eTMF Quality Management
- Leadership & Quality Culture Development
Training is delivered virtually or onsite globally, across the U.S., EU, UK, and Asia.