Strategic advisory and execution on the business side of outsourced research, clinical development, and manufacturing
Our Clinical Business Operations (CBO) practice offers a comprehensive and flexible means of improving the planning, cost efficiency, and outcomes of programs that are commonly outsourced in life sciences, including preclinical research and development, clinical studies, and manufacturing.
We apply expertise in outsourcing strategy, performance-based contracting and negotiation, and study-level clinical finance to help clients better understand their clinical spend and maximize the value of relationships with research labs, Clinical Research Organizations (CROs), contract manufacturers, and other providers. Ultimately, we aim to improve our clients’ ability to reach key milestones on time and on budget.
Our CBO team comprises experts in four integrated areas:
- Preclinical Outsourcing Strategy and Management; including definition of the pathway to complete IND submissions, vendor selection and negotiation.
- Clinical Outsourcing Strategy and Management; ranging from strategic planning and contracting through change order management, monitoring, and reporting across all providers engaged in the successful completion of studies. We also conduct independent investigator budget modeling and manage structure and negotiation of individual site agreements.
- Clinical Finance; bridging the gap between Finance and R&D or 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
Key Considerations
- 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 strategies that anticipate clinical and CMC needs in earlier stages of development.
- Our specialists understand preclinical, CMC and clinical development processes, supply chains and timelines, and many other internal and external factors that inform outsourcing strategy in biopharma. Learn more here.
- Our CBO consultants regularly partner with clients’ Clinical Operations teams and with other Danforth consultants in Finance and Accounting roles, ensuring efficient and timely flow of information between functions.
How Danforth Can Help
Preclinical Contracting
We manage vendor selection and negotiation, leveraging extensive knowledge of applicable providers, and ensure adherence to project budgets and timelines.
Clinical 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. Learn more about our risk management services.
How else can we help?
Learn about our additional capabilities