Clinical Trial Forecasting: Managing the Challenges and Avoiding the Fines

Clinical Trials, Commercialization and HEOR, Life Sciences, Pharmaceutical Regulation ,
  • August 03, 2016

With globalization, large numbers of sites, recent regulatory requirements and an increasing number of CROs and vendors, clinical trials are constantly becoming more complex. Given that clinical trial costs are one of the biggest expense categories for biopharmaceutical companies—the average cost of bringing a drug to market in the US is estimated to be $1.3-1.7 billion—it’s critical that CROs and Sponsors forecast accurately.

However, manual processes have made forecasting of clinical trials challenging, leading to difficulties in reforecasting and cash management (and as a result, difficulties in maintaining site satisfaction) as well as hefty fines.

Viewers will learn more about:

  • The consequences of poor forecasting
  • The difficulties of reforecasting with manual systems
  • The complexities that make forecasting so challenging
  • How technology that is purpose-built for clinical trials can help CROs and Sponsors forecast more effectively and accurately
Keywords:

Speakers

Jay Trepanier, Senior VP and General Manager, Bioclinica Financial Lifecycle Solutions

Jay brings more than 20 years of financial and operational experience across several industry sectors including technology, healthcare, life sciences, IT, and oil and gas.

Prior to joining Clinverse, Jay served as the Chief Financial Officer and/or Chief Operating Officer at various companies including Jones and Frank, Alphanumeric, and DataFlux. Additionally, he served as the Chief Financial Officer of Etrials Worldwide, an eclincial solutions provider to Pharmaceutical companies, prior to its acquisition by Merge Healthcare.

Jay received his MBA from Southern New Hampshire University, a BS in Accounting from West Virginia University, and a BS in Business from the University of New Hampshire. In addition, he is a licensed CPA and holds certifications in Six Sigma and project management. Jay has also served on several boards of directors including the UNC Children’s Hospital, DataFlux, and Alphanumeric.

James Sacchetta, Manager, Technical Operations, Premier Research

James Sacchetta has over 9 years of experience working with Investigator grant payments. In his current position as Manager, Technical Operations James has globalized the payment process for Premier Research using ClinPay and leads a team responsible for contract setup and payment generation. He worked for a large CRO early in his career and has used multiple platforms to perform investigator grant payment generation and reconciliation on a global scale.

Earlier in his career, he worked in Project Management and was responsible for all project deliverables, including investigator grants. James has a Masters of Business Administration in Pharmaceutical and Healthcare Management from the University of Sciences in Philadelphia. In addition, James has a Bachelors of Science from Loyola University Maryland in Baltimore Maryland.

Who Should Attend?

C-level and senior professionals responsible for clinical trials, including:

  • Finance
  • Clinical Operations
  • Project Management

Xtalks Partners

Bioclinica

Bioclinica is a specialty services provider that utilizes expertise and technology to create clarity in the clinical trial process. Bioclinica is organized by three business segments to deliver focused service supporting multifaceted technologies. The Medical Imaging and Biomarkers segment provides medical imaging and cardiac safety services and includes a molecular marker laboratory. The eHealth Solutions segment comprises an eClinical technology platform and professional services along with financial lifecycle, safety and regulatory solutions. Under the Global Clinical Research segment, Bioclinica offers a network of research sites, patient recruitment-retention solutions, and a post-approval research division.

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