S.P.E.E.D Advantage Services

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• Regulatory Compliance (FDA, EMA, ICH/GCP)
• SOP/Policy Development or Overhaul
• Workflow & Process Optimization
• Risk Assessment & Mitigation Strategy
• Feasibility Assessments
• Endpoint Validation
• Study Startup Optimization
• Protocol Development & Scientific Review
• Inspection Readiness Strategies

We help:

Sites attract the right sponsors

Sponsors engage high-performing, diverse, globally distributed sites

Our support includes:

• Site capability deck development
• Sponsor outreach campaigns
• Feasibility optimization
• Enrollment & patient diversity mapping
• Rapid site replacement sourcing
• International site identification (U.S., EU, LATAM, APAC)

• CRAs (All Levels)
• CTMs
• Project Managers
• Clinical Trial Assistants
• Drug Safety Specialists
• Quality Assurance Auditors
• Biostatisticians & Data Managers
• CRFs Programmers
• IRB Support Specialists
• Regulatory Leads
• Clinical Operations Directors
• Medical Monitors / Physicians
• Principal Investigators (where applicable)

Delivered virtually or onsite.

• GCP & Global Regulatory Training
• Inspection Readiness Workshops
• TMF/eTMF Quality & Structure Training
• Risk-Based Monitoring
• Vendor Oversight & KPI/Metric Management
• Protocol & ICF Deep-Dive Training
• Site Staff Training (CRC, PI, Sub-I)
• Leadership & Quality Culture Development

• Bid Defense Readiness Assessments
• Operational Capability Gap Analysis
• Mock Bid Defense Presentations & Coaching
• Stakeholder Alignment & Strategic Messaging
• Feasibility & Resource Validation
• Risk & Contingency Planning
• Post-Bid Performance Tracking & Optimization

• Clinical Trial Audits (All Phases, Global)
• Investigator Site Audits
• Vendor & CRO Oversight Audits
• TMF/eTMF Audits & Mock Reviews
• Mock Regulatory Inspections (FDA, EMA, MHRA, PMDA)
• CAPA Development, Tracking & Effectiveness Checks

• IRB Services
• Quality Management System Development
• Inspection War Rooms
• Diversity Strategy Planning
• Vendor Qualification & Selection Support

We are partnered with Medidata Rave to support:

• Study builds
• EDC
• CTMS
• eCOA
• eConsent
• Data review workflows

• Global Site Identification
• PI & Site Vetting
• Feasibility Assessments
• Diversity & Inclusion Planning
• Operational Alignment
• Ongoing Site Engagement
• Risk & Contingency Planning