Your Clinical Research Site Operations Partner
Why Sites Choose Us
Divergent S.P.E.E.D. provides hands-on clinical operations support to help research sites strengthen quality, address operational challenges, and maintain ongoing study readiness.
We work as an extension of your site team—bringing senior-level clinical operations experience, practical solutions, and responsive support when you need it.
- 20+ Years of Clinical Research & Operations Experience
- Responsive, Hands-On Operational Support
- Customized Solutions—Never One-Size-Fits-All
- Site Rescue & Performance Improvement
- Study Start-Up Support
- Protocol Compliance Support
- Regulatory & Essential Document Readiness
- Regulatory & Essential Document Readiness
- PI & CRC Coaching
- Site Process & Workflow Improvement
- Patient Recruitment & Retention Support
- Inspection & Audit Readiness
- Staff Training & Development
What We Offer
Ongoing Quality & Site Readiness
Monthly Quality & Performance Check-Ins
Proactive support to help your site maintain quality, compliance, and operational readiness throughout the study—not only when an audit or inspection is approaching.
Monthly Quality & Performance Check-Ins
Monthly Quality & Performance Check-Ins
Routine reviews of documentation, deviations, data quality, site workflows, protocol compliance, and emerging operational risks.
SOP Revisions & Targeted Training
Review and strengthen outdated procedures while providing targeted staff training aligned with protocol, regulatory, and site requirements.
Protocol Amendment Implementation
Support site teams with amendment training, document updates, workflow changes, and operational implementation.
CAPA Development & Effectiveness Support
CAPA Development & Effectiveness Support
Support root-cause analysis, CAPA development, implementation, follow-up, and effectiveness checks to help prevent recurrence.
On-Demand Site Operations Support
CAPA Development & Effectiveness Support
Responsive support for protocol questions, deviations, documentation concerns, EDC issues, and other operational challenges requiring timely guidance.
CRC Mentorship & Development
Practical coaching and mentorship designed to strengthen coordinator knowledge, confidence, accuracy, organization, and clinical trial performance.
New Staff Onboarding & Training
Structured onboarding and role-specific training to help new research personnel understand site processes, study responsibilities, and clinical research requirements.
Audit & Inspection Readiness
Readiness assessments, document reviews, staff preparation, and mock inspections designed to identify and address gaps before an audit or regulatory inspection.
Regulatory & Essential Document Support
Help site teams organize, review, maintain, and strengthen essential regulatory documentation throughout the study lifecycle.
Patient Safety & Protocol Compliance Support
Patient Safety & Protocol Compliance Support
Support site processes related to informed consent, safety reporting, protocol adherence, subject documentation, and GCP requirements.
Data Quality & Query Resolution Support
Patient Safety & Protocol Compliance Support
Help site teams address data backlogs, outstanding queries, reconciliation needs, and documentation issues that may affect data quality or study timelines.
Study Start-Up Support
SITE RESCUE & PERFORMANCE RECOVERY
SITE RESCUE & PERFORMANCE RECOVERY
- Site Start-Up Readiness
- Assess operational, staffing, facility, and resource readiness before study activation.
- Regulatory & Essential Document Preparation
- Support collection, organization, review, and completion of required start-up documentation.
- Site Initiation Visit (SIV) Preparation
- Prepare investigators and site staff for study expectati
- Site Start-Up Readiness
- Assess operational, staffing, facility, and resource readiness before study activation.
- Regulatory & Essential Document Preparation
- Support collection, organization, review, and completion of required start-up documentation.
- Site Initiation Visit (SIV) Preparation
- Prepare investigators and site staff for study expectations, responsibilities, workflows, and SIV readiness.
- Protocol Operationalization
- Translate protocol requirements into practical site workflows for screening, enrollment, visits, procedures, and follow-up.
- Staff Roles & Responsibility Planning
- Clarify PI, Sub-I, CRC, regulatory, pharmacy, laboratory, and other study-team responsibilities.
- Delegation & Training Readiness
- Support delegation planning and ensure required study-specific training is completed and documented.
- Source Document & Workflow Development
- Develop or strengthen source-documentation processes, visit workflows, checklists, and study-specific tools.
- Investigational Product Readiness
- Support site processes for receipt, storage, accountability, documentation, and study-specific IP requirements.
- EDC & Study Systems Readiness
- Help ensure appropriate personnel are trained and prepared to use required study systems and technology.
- Patient Recruitment & Enrollment Planning
- Develop practical screening, recruitment, pre-screening, and enrollment workflows based on the site's patient population.
- Start-Up Risk & Gap Assessment
- Identify potential operational barriers before activation and develop mitigation plans.
- Activation & First-Patient Readiness
- Confirm the site, team, documentation, systems, and workflows are prepared to begin enrollment and execute the study.
SITE RESCUE & PERFORMANCE RECOVERY
SITE RESCUE & PERFORMANCE RECOVERY
SITE RESCUE & PERFORMANCE RECOVERY
Focused operational support for sites experiencing:
- Recurring Protocol Deviations
- Repeated Monitoring Findings
- Regulatory & Documentation Deficiencies
- Staff Performance & Training Gaps
- Enrollment Challenges
- Data & Query Backlogs
- CAPA & Corrective Action Needs
- PI Oversight Concerns
- Sponsor/CRO Escalations
- Audit or Inspection Findings
We help identify
Focused operational support for sites experiencing:
- Recurring Protocol Deviations
- Repeated Monitoring Findings
- Regulatory & Documentation Deficiencies
- Staff Performance & Training Gaps
- Enrollment Challenges
- Data & Query Backlogs
- CAPA & Corrective Action Needs
- PI Oversight Concerns
- Sponsor/CRO Escalations
- Audit or Inspection Findings
We help identify the root cause, stabilize operations, and build a practical path toward sustainable site performance.
Who We Support
SITE RESCUE & PERFORMANCE RECOVERY
When to Bring Us In
Divergent S.P.E.E.D. provides operational support for:
- Independent Clinical Research Sites
- Physician Practices Entering Clinical Research
- New & Emerging Research Sites
- Established Research Sites
- Multi-Site Research Organizations
- Sites Experiencing Operational or Performance Challenges
- Sites Preparing for Growth or New Study Opportunities
When to Bring Us In
How We Work With Your Site
When to Bring Us In
You don't have to wait until your site is in crisis. Divergent S.P.E.E.D. can support your site when you are:
- Launching a New Research Program
- Preparing to Start a New Study
- Onboarding New Research Staff
- Managing Rapid Growth
- Experiencing Staff Turnover
- Seeing Recurring Protocol Deviations
- Receiving Repeated Monitoring Findings
- Managing Data or Q
You don't have to wait until your site is in crisis. Divergent S.P.E.E.D. can support your site when you are:
- Launching a New Research Program
- Preparing to Start a New Study
- Onboarding New Research Staff
- Managing Rapid Growth
- Experiencing Staff Turnover
- Seeing Recurring Protocol Deviations
- Receiving Repeated Monitoring Findings
- Managing Data or Query Backlogs
- Struggling With Enrollment
- Addressing Sponsor/CRO Concerns
- Developing or Implementing CAPAs
- Preparing for an Audit or Regulatory Inspection
- Recovering a Study or Site That Has Fallen Behind
How We Work With Your Site
How We Work With Your Site
How We Work With Your Site
Our support is designed around your site's needs, priorities, and operational environment.
- Assess
- Understand your site's current operations, challenges, risks, and priorities.
- Identify
- Determine the root causes behind performance, process, training, or compliance gaps.
- Plan
- Develop practical recommendations and an actionable path forward.
- Implem
Our support is designed around your site's needs, priorities, and operational environment.
- Assess
- Understand your site's current operations, challenges, risks, and priorities.
- Identify
- Determine the root causes behind performance, process, training, or compliance gaps.
- Plan
- Develop practical recommendations and an actionable path forward.
- Implement
- Work alongside your team to put solutions, training, workflows, and improvements into practice.
- Strengthen
- Build the knowledge, processes, and operational discipline needed to sustain improvement.
Support can be provided virtually, onsite, or through a customized combination of both.
What Success Looks Like
How We Work With Your Site
How We Work With Your Site
Our goal is to help your site build stronger, more sustainable clinical research operations.
- Better-Prepared Research Teams
- Stronger Protocol Compliance
- More Consistent Site Processes
- Improved Documentation Quality
- Fewer Recurring Operational Issues
- Stronger CAPA Implementation
- Improved Study Readiness
- Greater Sponsor/CRO Confidence
- Stronger Audit
Our goal is to help your site build stronger, more sustainable clinical research operations.
- Better-Prepared Research Teams
- Stronger Protocol Compliance
- More Consistent Site Processes
- Improved Documentation Quality
- Fewer Recurring Operational Issues
- Stronger CAPA Implementation
- Improved Study Readiness
- Greater Sponsor/CRO Confidence
- Stronger Audit & Inspection Readiness
- More Confident Site Leadership
- Sustainable Operational Improvements
Success isn't simply correcting today's problem. It's helping your site build the knowledge, processes, and operational discipline to perform stronger tomorrow.