Bayer implemented an integrated system to manage the finances of all interventional clinical trials. This covers the early planning five years down the road and the operational management of ongoing trials, including forecasting on annual, quarterly, and monthly level, whole study and per country. We'll give an intro to our approach and integration with different systems and discuss strength and development areas and give an outlook.

Biopharmacetical sponsors with little institutional clinical history are often at the mercy of large clinical datasets. Benchmark comparisons are often not relevant when studies are in rare or ultra-rare diseases. Leveraging internal clinical metrics, even when the data is sparse, can help immensely to hone clinical trial forecasts. This session will look at CTA contracting timelines, feasibility, patient recruitment, and other clinical data as forecasting sources.

The ability to accurately forecast and predict is critical to clinical trial outcomes, yet this remains a top challenge in study planning and execution. We turn to data for guidance but how do we ensure the data we are referencing is reliable? This session will touch on key use cases for better, industry-indicative data points and how technology can help to ensure data integrity for better decision making and smarter trials.

Budgeting and payments are always hot topics. But why do we always seem to talk about the same strategies? While the fundamentals of these processes still ring true, technology is now enabling novel approaches to operationalize clinical finance strategies. Join this session with Medidata’s VP of Product to learn how to optimize what we know already works well, and hear industry examples of fresh approaches to managing budget and payment processes.

Patients often benefit through continued treatment by investigational products, so it is important to develop a plan for allowing patients to continue receiving such treatments that maximize return on investment (ROI).  Historically, when a submission is complete, or development of a product is discontinued, we allow patients to remain on study through the parent protocol.  In this presentation, we will examine the cost savings for moving 9 parent protocols into a master continuation protocol, allowing us to consolidate 9 studies into one and reduce ongoing costs and global footprint of providing patients with treatment.

Unfortunately, budgeting for investigator site costs is not as simple as composing a site budget and multiplying by projected number of sites and patients. Trials may have multiple complex variables, including out-of-scope procedures, unscheduled visits, mid-study protocol changes, SOC reimbursements, inconsistent screen failure time-points, patient expense, and more. This presentation will discuss relatively painless ways to budget for site costs and how to deal with confounding variables reasonably and effectively.

Small companies with limited cash need to accurately budget and forecast the cost of their clinical trial portfolio, but also cannot afford a team of clinical financial analysts to do so. Join me in this presentation to hear about techniques that expand the capacity of one person to efficiently budget and forecast a portfolio of trials, without losing their mind!

In this session learn: What are the key oversight elements in the financial management of clinical service providers; Evaluation of cost drivers for different clinical study models: classic, remote, decentralized; Considerations for milestone tracking and payment schedules; Importance of analyzing different clinical study scenarios to determine the impact on execution strategy; How to leverage technology to expedite decision making and improve transparency in vendor financial oversight.

Sponsors and CROs need more than change management to operationalize decentralized trials. In this session, Kyle Hogan will outline the approaches sponsors and CROs can take to build value in the decentralized trial participant journey, from pre-implementation to study launch and monitoring. 

Delays in clinical trial patient enrollment are significant challenges for sponsors, especially for biomarker-targeted investigational therapies associated with rare genomic variants. Join us and discover the solutions offered by SOPHiA GENETICS, leveraging insights from multimodal datasets - including 770’000 genomic profiles - curated across 780+ healthcare institutions. We can better enable biomarker-driven clinical trials in oncology and inherited rare disorders to meet recruitment goals by identifying potential sites worldwide.

Hear about Bayer's preparation for rolling out a new study start-up tool, specifically related to the Contracting & Budgeting module. Development of an ideal "wish list" for the module, sprint workshops, critically assessing processes, and garnering a new working group to champion the new way of working have all been part of the overall strategy. There will be more to share, perhaps even overcoming identified pain points. Stay tuned!

Industry-sponsored clinical trials benefit from favorable research infrastructures and streamlined study start-up processes. Currently, clinical trials worldwide face challenges regarding study start-up due to the time needed to finalize the contracting for a specific trial between the sites involved and the sponsor. This process currently in many countries is difficult and time-consuming. The talk should provide an overview of examples from different trial locations to address this problem.

Ancillary technologies and services can be a headache for the most seasoned clinical operations veterans.  Often times the contract process drags on; and as a result, those same services end up on the critical path to the first-patient-in milestone. 

This practical presentation will present ideas on how to leverage a predefined rate card to generate an easy to execute startup agreement, all while finding the potential for additional discounts.

While cyber risk is not new, cybersecurity language in CTAs and remote monitoring agreements is.  Security incidents can impact multiple parties, creating mutuality of risk. This session will discuss sample cybersecurity language from research institutions and pitfalls for sponsors.   Hear about lessons learned from sponsor audits of their vendor agreements for compliance with CTA cybersecurity obligations.  Common gaps make sponsor CTA obligations heavier.  Learn about contract provisions that mitigate risk.