Frequently Asked Questions
How can a start-up biotech company determine the right CRO partner size?
The right CRO partner size depends on several factors, including your specific therapeutic area, geographic scope, and internal resources. However, for most start-up biotech companies, mid-sized specialized CROs offer the best balance of capabilities and attention. When evaluating potential partners, consider:
How your study will be prioritized relative to their other clients
Their staff turnover rate and team consistency measures
Whether you'll have direct access to senior leadership
Their flexibility in payment terms and ability to align with your funding cycles
Their specific expertise in your therapeutic area
Large, multitherapeutic CROs often prioritize their larger clients, leading to the "small fish in a big pond" syndrome that can result in deprioritization, staff turnover, and inflexible approaches that don't align with startup needs.
How can we align our clinical development timeline with our funding cycles?
Aligning clinical development with funding cycles is critical for startups. Consider these strategies:
Milestone-Based Planning: Break your clinical program into discrete phases with clear deliverables that align with investor expectations
Adaptive Trial Designs: Incorporate interim analyses and go/no-go decision points that coincide with funding milestones
Phased Contracting: Structure CRO contracts in phases that align with your funding rounds
Prioritize Critical Path Activities: Focus resources on the activities that directly support your next value inflection point
Consider Alternative Payment Structures: Work with vendors who offer milestone-based payment options that align with your cash flow
Our Funding-Aligned Trial Planning Guide provides a comprehensive framework for this approach.
What are the most common budget pitfalls for startup biotech companies in clinical trials?
Startup biotech companies frequently encounter these budget pitfalls:
Underestimating Change Orders: With large CROs, change orders often reach 15-25% of the original contract value
Recruitment Delays: Each month of extended enrollment can cost $100,000-$300,000 in burn rate
Hidden Technology Costs: EDC, CTMS, and other systems often have unexpected implementation and maintenance fees
Staff Turnover Costs: The "A team to B team" transition leads to inefficiencies and knowledge gaps
Vendor Management Overhead: Managing multiple vendors creates administrative burden and integration challenges
Protocol Amendments: Changes to study design after initiation can significantly impact budgets
Working with a specialized CRO that understands startup constraints can help mitigate these risks through proactive planning and transparent budgeting.
How can community-based clinical trials benefit resource-limited companies?
Community-based clinical trials offer several advantages for resource-limited companies:
Reduced Infrastructure Investment: Leverage established networks instead of building your own site relationships
Faster Recruitment: Access to diverse patient populations through trusted community connections
Lower Per-Patient Costs: Reduced site overhead and monitoring expenses
Built-in Diversity: Meet diversity requirements without additional recruitment costs
Simplified Site Management: Coordinated network reduces the complexity of managing multiple sites
Our data shows that community-based approaches can accelerate enrollment by up to 40% and reduce overall study costs by 15-25% compared to traditional site-based models.
What are the benefits of integrating clinical trials and pharmacovigilance for startups?
Integrating clinical trials and pharmacovigilance offers particular benefits for startups:
Reduced Vendor Management: Single provider for both clinical operations and safety monitoring
Seamless Data Flow: Elimination of redundant data entry and reconciliation between systems
Earlier Signal Detection: Integrated analysis of clinical and safety data for faster identification of potential issues
Enhanced Risk Management: More robust Risk Management Plans based on comprehensive data
Operational Efficiency: Streamlined processes and reduced administrative overhead
For resource-limited start-ups, this integration can reduce operational costs by up to 20% while improving data quality and regulatory compliance.