Why investigators often lose money in conducting sponsored clinical trials

Instructor: Stephen Schwartz
Product ID: 700880
  • Duration: 60 Min
A proven process for investigators will be presented to address common deficiencies with respect to costs associated with clinical investigator site requirements for studay conduct.

recorded version

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Last Recorded Date: Apr-2008

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Why Should You Attend:

Clinical trial conduct contains many clinical investigator direct and indirect costs that are often not included by investigators in their budgets and contract negotiations. As an example- Profit (and the relevant tax burden) is often not included as an investigator cost. Many clinical trials are conducted at the investigator site to terms dictated by the sponsor contract that do not necessarily reflect clinical investigator site requirements for study conduct. An inappropriate contract creates additional costs for the investigator when this occurs. These costs generate performance challenges for both sponsor and investigator.

Areas Covered in the seminar:

  • How to identify ALL of the direct costs?
  • How to identify ALL of the indirect costs?
  • How to identify fixed costs?
  • What are the appropriate profit factors for each category?
  • How to estimate costs for delays in starting, cash flow, amendments etc?
  • Contract negotiation skills.
  • Investigator contract requirements that must be present.
  • Investigator contract requirements that are negotiable.
  • Metrics as a contract performance tool.
  • Managing the contract as a tool to enable project success

Who will benefit:

  • Sponsor program managers
  • Sponsor CRA’s
  • Investigators
  • CRC Managers

Instructor Profile:

Stephen Schwartz, is the founder of Solaris Research Corporation, Steve has a background in basic virology research, progressing into 10 years clinical research program administration in the pharmaceutical industry. Entering the CRO industry, he performed clinical monitoring and clinical quality assurance field service using that expertise to achieve a management position at the director level. 10 years of CRO experience culminated in the formation of his full service CRO in 1989, under the initial name of Commonwealth Clinical Research Corporation - now Solaris Research Corporation. Steve has also served as the investigator of several phase IV clinical trials and a member of an Institutional Review Board. Solaris provides clinical program management, clinical monitoring, CQA auditing and regulatory consulting. Solaris Research Corporation publishes monthly, an electronic clinical trial conduct newsletter.

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