Investor Confidence and the Criticality of Control and Precision in Clinical Trial Finance

The most variable and material line item on the Biotech books is R&D and clinical trial spend. In today’s capital constrained market public/clinical-stage biotech companies need a tight gasp and understanding on runway. Gone are the days when a directional ‘hand-wave’ can suffice for Board and Investor communications on clinical program timelines and cash runway. 

More and more companies have restructured portfolios to extend runway and further pipeline programs. Public filers can’t afford to miss the mark on the financial management and execution of clinical trials, as there is no patience or latitude from ‘the Street’.  

Instead, a sophisticated understanding of cost drivers, timeline nuances, enrollment trends, pass-through costs and investigator spend is paramount for specificity and compliance. Today, effective and efficient forecasting on trial progress, enrollment and budget is a must.  

What can you do? 

• Understand the drivers of failure, reasons for timeline slippage and root cause of change 
• Establish materiality thresholds for R&D and clinical trial costs 
• Hone-in on control areas, including: Clinical Trial Accruals, Fluctuation Analyses, IT Controls, CRO and Third Party Assessments 
• Document your accrual methodology – Straight-line vs. a unit-based, per patient approach; use of timeline, site and patient curves 
• Ensure completeness and accuracy of data, coupled with strong review processes and permissions 
• Avoid reliance on vendor estimates – Only 9% of biotech companies fully trust the completeness and accuracy of these estimates 

There is a better way - out of spreadsheets, into SaaS software that is both SOC and SOX compliant - to grab the reigns and control your clinical trial finances with precision, confidence and measurable efficiency.