Execution infrastructure and embedded expertise for clinical-stage and platform biotech organizations.
PMO & Workflow Infrastructure
We design and implement fit-for-purpose execution systems that increase milestone visibility, strengthen vendor governance, and align cross-functional teams.
Capabilities include:
• Program & portfolio dashboards
• Smartsheet implementation and workflow design
• Study-level milestone tracking
• Vendor governance frameworks
• Contract and change order oversight systems
• Inspection readiness infrastructure (FDA, EMA, BIMO)
• Executive reporting and board-ready visibility
When this is right for you:
• Growing portfolio complexity
• Scaling beyond spreadsheets
• Preparing for regulatory inspection
• Leadership needs greater milestone confidence
Fractional Biotech Expertise
We provide experienced embedded consultants across core development functions — strengthening execution without long-term headcount commitments.
Functional Areas:
Clinical Operations
• Study startup coordination
• CRO oversight
• Multi-study portfolio support
Contracts & Vendor Governance
• MSA & CTA oversight
• Change order governance
• Budget and accrual visibility
Data Management
• DM leadership & CRO oversight
• Database readiness support
Medical Writing
• Protocols, IBs, DSURs, clinical documentation
Regulatory & QA Coordination
• Cross-functional milestone alignment
• Inspection preparation & response
Engagement Models
• Embedded fractional leadership
• Milestone-based execution support
• Retainer-based governance oversight