Uncertain financial times, shifting labor markets, and inflation at record-high levels have put intense pressure on operating expenses and cash flow for pharma companies.  Now more than ever, accurate trial forecasts and predictive cost models are necessary that build in inflationary risks and other tolerances.  CROs who help their sponsors do this well will be favored and will appear as partners who are good stewards of money.

Managing clinical trials, of any size and complexity, requires strategic planning, negotiations of agreements/budgets to ensure adequate resource allocation, risk mitigation and cost efficient execution. In order to successfully deliver innovative therapies to patients with unmet medical needs the trial management regulatory guidelines need to be standardized further, and robust methods of evaluation of study protocol complexity developed in conjunction with risk management strategies, adequate provisions in clinical trials agreements and accurate budgeting are needed.

When it comes to budgeting, contracting, and payments, the sponsor-investigator site relationship has long been characterized by significant difficulties and contention. That these challenges have proven so enduring over time underscores their inherently persistent nature. Using multiple real-world anecdotes, this presentation will explore some of the more common issues and analyze potential effective ways these challenges can be alleviated and even subdued. 

Site contract and budget negotiations have contributed to significant delays to study start-up for years. The impact of the pandemic, inflation, and staffing shortages has significantly increased site burden. While a site-centric approach by Sponsors that incorporates FMV principles and aligns with Site expanded needs can be an effective strategy for efficient site contract and budget negotiation in this environment, implementation requires Site and Sponsor collaboration.

Resource estimation algorithms are key for clinical operations, especially for site management. We will sketch our algorithm approaches and how they evolved over time driven by application of RBQM, reflecting feasibility efforts, etc. Further, we will highlight our approach to be consistent between early estimation on study level and breakdown on country level. Finally, we will touch validation with time tracking.

The presentation will present a case study on how to evolve a group to maximize resource usage together with new processes and technology to have an operational impact on the business.

This presentation covers how Bayer's External Relationship Governance model adds value to the business ensuring a reliable partnership and complements the Sourcing & Procurement Functions, sharing current trends on procurement roles and the necessity to have an operational perspective in sight, with different approaches from different business necessities and how to best manage CMOs, 3PLs and Clinical Trials partners.