VirtuoMark

VirtuoMark provides clinical development and clinical operations consulting to biotech startups and emerging life sciences companies.

We partner directly with founders and executive teams to design and execute clinical trials, build clinical operations infrastructure, and translate promising science into executable clinical programs without the overhead of a full-time Head of Clinical.

Our work focuses on clinical strategy, trial startup, vendor oversight, and evidence generation, not administrative or regulatory paperwork.

Think of us as your fractional clinical leadership team.

WHAT WE DO

✔ Build clinical development strategy and clinical trial roadmaps
✔ Design protocols and operationally realistic clinical trials
✔ Lead clinical trial startup and execution planning
✔ Select and oversee CROs, CDMOs, and vendors
✔ Structure scopes of work, contracts, budgets, and timelines
✔ Establish SOPs and scalable clinical operations systems
✔ Conduct feasibility and risk assessments
✔ Design evidence generation and real world evidence (RWE) programs
✔ Align clinical programs with payer, reimbursement, and market access goals

In short, we turn promising science into clinical trials that are ready to execute.

HOW WE ENGAGE

✔ FRACTIONAL CLINICAL OPERATIONS LEADERSHIP
Embedded support for growing biotech teams
Clinical strategy plus operational ownership
Typical engagement: 10 to 20 hours per week

✔ CLINICAL PROGRAM DESIGN & TRIAL STARTUP
• Clinical development plans
• Protocol and study design
• Trial feasibility and risk mitigation
• Startup strategy and resourcing
• Timelines and budgets

✔ CRO, CDMO & VENDOR OVERSIGHT
• Vendor evaluation and selection
• Scope of work development
• Budget modeling and cost control
• Contract and MSA strategy
• Performance oversight

✔ EVIDENCE GENERATION & MEDICAL AFFAIRS STRATEGY
• Clinical utility studies
• Real world evidence (RWE)
• HEOR and payer evidence planning
• Post-market and lifecycle studies

✔ SENIOR CLINICAL WRITING • Protocols • Investigator Brochures • Clinical Study Reports • Strategic study documentation