A proactive strategy and program to effectively manage the business side of outsourced clinical studies

Our Clinical Business Operations (CBO) practice offers a comprehensive solution to manage the outsourcing of clinical development, combining expertise in strategic contracting, sourcing and finance management to maximize the value of relationships with Clinical Research Organizations (CROs) and other providers. Our CBO team is expertly qualified to manage the overall process, from strategic planning and contracting through execution, monitoring and reporting.

Tony Carita

Meet one of our experts

Tony Carita, Managing Director

Key Considerations

Despite the high stakes of outsourced clinical trials, there are acute disconnects between the stakeholders – resulting in program delays, budget surprises and misaligned expectations. The following dynamics are all too common among life science companies working with CROs and related vendors:

  • The burden on clinical staff to manage the business aspects of the outsourcing process diverts their focus away from mission-critical trial execution.
  • Ineffective negotiation with CROs, CMOs and other vendors directly leads to unnecessary spending and higher costs.
  • General contract terms don’t hold providers accountable for performance.
  • Poor oversight of CRO, CMO and vendor activities drives unplanned contract change orders, often with inappropriate cost escalations, leading to budget overruns.
  • Inaccurate clinical budgets result in big financial surprises and pressure on cash balances.

How Danforth Can Help

Customized strategic outsourcing planning

We define the clinical outsourcing strategy and plan based on your in-house capabilities and special requirements, and coordinate with Clinical Operations and Finance to forecast the outsourcing budget.

CRO/CMC/Vendor bidding and selection

In conjunction with Clinical Operations, we identify appropriate candidate vendors, prepare the Request for Information (RFI), Request for Proposal (RFP), analyze incoming proposals and facilitate bid defense meetings to make recommendations — including a Vendor Selection Report detailing the scoring process and final decision to ensure compliance with regulatory requirements.

Contract and change order management

We assist in the negotiation of the Master Services Agreement (MSA), Statement of Work (SOW), budget proposal and payment schedule with the vendor and execute change orders as needed.

Vendor oversight

We assist with the development, implementation and tracking of Key Performance Indicators (KPIs)/Service Level Agreements (SLAs) to measure vendor performance and document vendor oversight per compliance. We will also assist with right-sized governance to facilitate effective issue resolution.

Optimized coordination with Clinical Operations and Finance

We ensure timely and high-quality information flow from Clinical Operations to Accounting, enhance forecasting and accrual accuracy and minimize surprise spending.

Integrated team approach

We provide access to a team of professionals with highly specialized clinical business operations expertise, integrating seamlessly with your internal resources.

How else can we help?

Learn about our additional capabilities