Site Rescue & Remediation
When site performance begins to decline, we help identify the root cause, stabilize operations, and develop a practical path toward sustainable improvement.
We provide support for:
- Recurring protocol deviations
- Repeated monitoring findings
- CAPA development and implementation
- Data and query backlogs
- Regulatory documentation deficiencies
- Staff performance and training gaps
- Enrollment challenges
- PI oversight concerns
- Sponsor and CRO escalations
- Inspection findings
- Study rescue and recovery planning
Site Readiness & Quality
We help research sites identify quality and operational gaps before they become monitoring findings, sponsor escalations, or inspection risks.
- Site Readiness Assessments
- Evaluate site processes, documentation, staff preparedness, protocol execution, and overall operational readiness.
- Mock Regulatory Inspections
- Prepare investigators and site teams for FDA and other regulatory inspections through realistic readiness assessments.
- Regulatory & Essential Document Reviews
- Identify documentation gaps and strengthen regulatory-file and essential-document readiness.
- Monitoring Finding Assessments
- Evaluate recurring monitoring findings and address underlying operational causes.
- CAPA Development & Follow-Up
- Support root-cause analysis, CAPA development, implementation, and effectiveness checks.
- Quality & Compliance Assessments
- Evaluate site practices against applicable GCP, regulatory, protocol, and internal requirements.
Site Operations & Performance
We help research sites strengthen workflows, solve operational challenges, and build sustainable processes that support consistent trial performance.
- SOP & Work Instruction Development
- Develop or strengthen site SOPs, policies, workflows, and work instructions to support consistent trial execution.
- Process & Workflow Optimization
- Identify bottlenecks, role gaps, inefficient processes, and communication breakdowns affecting site performance.
- Protocol Operationalization
- Translate protocol requirements into practical site workflows for successful study execution.
- Risk Assessment & Mitigation Planning
- Identify operational and study-level risks and develop practical mitigation strategies.
- Site Performance Improvement
- Address recurring deviations, data-query backlogs, documentation deficiencies, enrollment challenges, and other performance concerns.
- Study Start-Up Support
- Strengthen site readiness through operational planning, staff preparation, document readiness, and study-specific workflows.
- New Research Site Development
- Help physician practices and emerging research sites establish the infrastructure, processes, training, and quality systems needed to conduct clinical trials.
Site Growth & Sponsor Readiness
We help research sites strengthen how they present their capabilities, respond to feasibility opportunities, and prepare to compete for clinical trials.
- Site Capability Development
- Develop professional materials that showcase therapeutic expertise, patient populations, investigator experience, infrastructure, and site capabilities.
- Feasibility Readiness
- Strengthen feasibility responses and clearly communicate enrollment potential, operational capabilities, and study readiness.
- Sponsor & CRO Readiness
- Prepare site teams for qualification visits, sponsor discussions, feasibility assessments, and study-selection activities.
- Site Positioning
- Clearly communicate site strengths, patient access, capabilities, and differentiators to prospective sponsors and CROs.
- Study Opportunity Preparation
- Evaluate potential study opportunities and prepare the operational information needed to pursue appropriate clinical trials.
Training & Development
We turn clinical research requirements into practical, real-world training that helps site teams understand what to do, why it matters, and how to do it consistently.
- Good Clinical Practice (GCP) & Regulatory Fundamentals
- Clinical Research Coordinator Training
- PI & Sub-Investigator Responsibilities
- Informed Consent Process & Documentation
- Source Documentation & ALCOA+ Principles
- Protocol Compliance & Deviation Prevention
- AE/SAE Identification & Reporting
- EDC, Data Queries & Data Quality
- Investigational Product Accountability
- Regulatory & Essential Document Management
- Monitoring Visit Preparation
- Audit & Regulatory Inspection Readiness
- CAPA & Root-Cause Analysis
- Patient Recruitment & Retention
- Site Leadership & Research Management
- Sponsor/CRO Communication & Escalation
- New-to-Research Staff Onboarding
Flexible Training Options
Training is available virtually or onsite and can be customized to the experience level, operational needs, and clinical trial portfolio of each research site.