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

Our Clinical Business Operations (CBO) practice offers a comprehensive solution to manage the outsourcing of clinical development and manufacturing, combining expertise in strategic contracting, sourcing, supply chain and finance management to maximize the value of relationships with Clinical Research Organizations (CROs) and other providers.

Our CBO team comprises experts in three integrated areas:

  • Clinical Outsourcing Strategy and Management; ranging from strategic planning and contracting through execution, monitoring and reporting
  • Clinical Finance; bridging the gap between Finance and Clinical Operations to improve accruals, analysis and forecasting
  • CMC/Supply Chain; advising on manufacturing and supply chain decisions in earlier clinical stages to ensure future scalability and cost efficiency
Tony Carita

Meet one of our experts

Tony Carita, Managing Director

Key Considerations

  • Our CBO specialists regularly partner with our Finance and Accounting consultants on client engagements, ensuring efficient and timely flow of information between functions.
  • We unburden your internal staff by managing the business aspects of the outsourcing process, which otherwise divert their focus away from core responsibilities.
  • We understand the importance of getting it right at the outset – for example, by building accountability into master service level agreements (MSAs) and devising forward-looking CMC strategies.

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.

Investigator Site Budgets and Contracts

We apply deep expertise in the nuances of site budgets and contracts, conduct independent assessments and perform the budget modeling based on your protocol to provide an unbiased estimate of investigator fees. Click here for details.

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. Click here for more information about our Clinical Finance services.

Alignment Between Clinical Study Execution and Drug Supply Management

We provide a holistic view and understanding of pharmaceutical supply chains, enabling compounded savings from clinical through commercialization.

Risk and Insurance Management

Insurance plays a major role in clinical trials, and our risk management specialists work closely with clients to design, negotiate and implement the right combination of policies. To start, insurance must be in place in each country outside the US prior to the trial’s submission to the local Ethics Committee, and this insurance must also dovetail with the US Product Liability policy. Another key area for assessment is the supply chain – both in the movement of clinical trial supply and transportation of commercialized drugs. Click here for information about our risk and insurance management services.


How else can we help?

Learn about our additional capabilities