DIVERGENT S.P.E.E.D: YOUR SITE OPERATIONS PARTNER
Why Sites Choose Us
Divergent S.P.E.E.D Clinical Quality Solutions delivers high-impact site support that eliminates delays, strengthens documentation quality, and keeps your research audit-ready every single day.
We operate as an extension of your team — providing senior-level clinical operations expertise without the CRO cost or long response times.
- Real-time support with rapid turnaround
- 20+ years of Clinical Operations & Oncology expertise
- Tailored solutions — never generic templates
- Site rescue + performance improvement
- Continuous audit-ready oversight
- Study start-up optimization
- Protocol compliance support
- Source document / essential document clean-up
- Proven ability to prevent audit findings and reduce operational errors
- Daily practices designed to maintain continuous inspection readiness
- PI and CRC coaching
- Site process mapping
- Regulatory binder rebuilding
- Retention + recruitment planning
What We Offer
Continuous Audit-Ready Oversight
Continuous Audit-Ready Oversight
A proactive, ongoing system that ensures your site remains compliant and inspection-ready — not just before an audit, but every day.
Monthly Quality Check-Ins
Continuous Audit-Ready Oversight
Routine reviews of documentation, deviations, EDC data, workflows, and protocol adherence.
SOP Revisions & Targeted Training
Modernizing outdated procedures and training staff to stay aligned with study and regulatory requirements.
Protocol Amendment Rollouts
Full rollout support including staff training, document updates, and operational implementation.
Rapid CAPA Development
Real-Time Help Desk Support
Fast, clear Corrective and Preventive Action plans to resolve issues and prevent recurrence.
Real-Time Help Desk Support
Real-Time Help Desk Support
Immediate responses to urgent questions, EDC issues, deviations, or operational challenges.
Coordinator Mentorship & Development
Hands-on coaching to strengthen coordinator confidence, accuracy, and performance.
New Staff Onboarding, Orientation & Training
Accelerated onboarding to ensure new hires are study-ready and compliant from day one.
Pre-Audit Preparation & Mock Visits
End-to-end readiness assessments, document reviews, and simulated inspections to uncover gaps before sponsors or regulators do.
Regulatory Document Management & TMF Oversight
Ensuring essential documents, regulatory binders, and TMF/eTMF files are complete, current, and inspection-ready at all times.
Patient Safety & Compliance Monitoring
Data Cleanup & Query Resolution Support
Ongoing review of safety reporting, adverse events, consent processes, and subject compliance to maintain GCP standards.
Data Cleanup & Query Resolution Support
Data Cleanup & Query Resolution Support
Proactive data reviews, timely query responses, and reconciliation support to keep your study data clean, accurate, and submission-ready.