WALTHAM, Mass., June 18, 2020 (GLOBE NEWSWIRE) -- Danforth Advisors, LLC, the life science industry’s leading resource for operational accounting, finance support and strategic CFO advisory, today introduced a Clinical Business Operations (CBO) practice designed to improve efficiency, minimize risk and derive the best possible value from outsourced clinical development programs.
Given the high costs and stakes of outsourced clinical trials, expert attention must be paid to the strategy, structure and management of the outsourcing process – from contract research organization (CRO) bidding and selection to vendor oversight and proper coordination with accounting. In smaller organizations, these tasks commonly fall to clinical operations teams, diverting attention away from study execution. Danforth’s CBO practice unburdens internal resources and brings specialized expertise in outsourcing strategy, contracts and negotiation to protect sponsors’ investment in outsourced programs. Beyond conserving capital, this results in contracts that incentivize performance, account for risk and facilitate timely issue resolution to minimize surprises. As clinical studies gradually resume in the wake of COVID-19, the Danforth team can restructure existing agreements to better suit sponsors’ revised objectives or timelines.
“The coordination of multiple, concurrent, outsourced clinical studies is an incredibly complex effort, from planning through oversight and completion,” said Tomasz Zastawny, Vice President, Head of Clinical Operations, Epizyme, Inc. “Without a dedicated internal resource to manage five separate contracts with three CROs, we turned to Danforth – who successfully negotiated $2.5 million in savings for one Phase 3 study alone. They also ensured effective communication between our clinical operations, accounting and legal teams with the CRO, keeping all parties apprised of changes or requirements to prevent delays.”
“It is our business to identify and solve challenges on the finance and operations side of life sciences. Having observed the complexities of the status quo, we were compelled to develop this new practice and assemble a team of specialists who know exactly how to derive the best performance and best value from CRO relationships,” said Chris Connors, President, Danforth Advisors. “This service fits seamlessly with our existing operational finance and accounting offering. Above all, we share the common goal of getting new therapies across the finish line with expediency and quality.”
Danforth’s CBO practice is led by Anthony Carita, Managing Director, who has more than 35 years of experience managing clinical outsourcing for small and large companies, both on the sponsor and CRO side. The practice includes the following services:
- Strategic outsourcing planning, including development of outsourcing strategies in coordination with clinical finance and clinical operations staff
- CRO/vendor bidding and selection, including preparation of Request for Information (RFI) and Request for Proposal (RFP) documents, analysis of the completed RFIs/RFPs and facilitation of bid defense meetings to ensure sound decision making
- Contract and change order management, including negotiations, budget proposals, payment schedule and execution of change orders
- Chemistry, Manufacturing and Controls strategy and execution, including advisory on manufacturing and supply chain decisions to ensure cost-effective scale up and identification of supply risk across geographical, environmental, economic and technological areas
- Vendor oversight, including establishment of governance and tracking of Key Performance Indicators to measure vendor performance, as well as to provide timely escalation and resolution of issues
- Optimized coordination with accounting, FP&A and clinical operations, ensuring timely information flow between these departments and improving forecasting and accrual accuracy to minimize surprise spending
Additional information about Danforth’s CBO practice is available here:
http://www.danforthadvisors.com/wp-content/uploads/2020/03/Danforth-Clinical-Business-Operations.pdf
About Danforth Advisors
Danforth is the financial backbone to hundreds of life science companies, providing integrated and scalable consulting teams ranging from staff accountant through CFO. The company’s services span the full breadth of a finance organization’s needs, whether short or long term, including accounting and operational finance support, capital raising, financial planning and analysis, IPO preparation, post-public SEC compliance and clinical business operations management. Founded in 2011, Danforth has been a strategic and trusted thought partner to more than 400 life science companies, private and public, across all stages of the corporate life cycle. The company is headquartered in Waltham, Massachusetts with additional operations in the emerging life science clusters of metropolitan New York, Pennsylvania and Colorado. Additional information is available at www.danforthadvisors.com.