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• www.ttc-llc.com

As our first note of 2009, may we take this time to extend our best wishes to you and yours for the New Year!

With the current economic climate we thought it would be helpful to focus this 'From the Help Desk' on the cost management advantages of the GrantPlan database. Since GrantPlan is used by most of the industry, TTC works directly with the largest Pharmaceutical Companies, Biotechnology Companies and CROs as well as many mid size and small organizations in all three sectors. This experience yields extensive best practice techniques for all types of clinical trials.

As you know, per patient clinical grant fees vary by the country in which you are conducting your clinical trial. Costs also vary between the different clinical sites within a particular country. The amount you pay your sites is a strategic decision for your organization. GrantPlan should be instrumental in this decision. The advantage GrantPlan provides is an understanding of the fair market range for each line item of your clinical grant.

Knowing what your peers are paying investigative sites enables you to forecast per patient costs for your clinical trial, allocate funds for your upcoming trials, and most importantly enroll and contract with your clinical sites quickly. 

Effective cost management is paramount in today's research & development efforts. With the cost to develop a drug now around $1 billion and clinical development being considered the largest single contributor, it is imperative to effectively manage the amounts paid to investigative sites. You must pay your investigative sites an appropriate amount for their efforts, however research shows that paying above that amount will not yield additional value. Utilizing GrantPlan will ensure you are paying the appropriate amount. In addition, GrantPlan enables you to decrease the amount of time needed to develop your investigator grant budgets; first by illustrating the current fair market range for your clinical grant line items, and second by providing a web-based budget development tool.

The Help Desk is here to help you use GrantPlan to its fullest potential. We encourage all of you to contact us so that we can help you utilize all of GrantPlan's functionalities and ensure that you are utilizing the best practices when developing your investigator grant budgets.

Please do utilize the help desk for any budgeting, forecasting, or technical questions you may have. You can always reach us at help@ttc-llc.com. Cheers and happy budgeting in 2009!

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• "Understanding the Costs of Outsourcing a Clinical Trial"
  February 18, 2009
  Outsourcing Clinical Trials Conference
  San Francisco, California, USA

• "Clinical Grant Budgeting & Negotiating in Latin America"
  March 9, 2009
  Drug Development in Latin America Conference
  Miami, Florida, USA

• "International Clinical Trial Budgets"
  March 23, 2009
  Rest of World Clinical Outsourcing Conference
  Princeton, New Jersey, USA

• "An Overview of the Economic Considerations when Running Clinical Trials in Emerging Economies" 
  April 21, 2009
  3rd Annual Clinical Trials in Emerging Economies Conference
  Prague, Czech Republic

• "Standard of Care: What Does the Data Say?"
  May 31 - June 3, 2009
  MAGI's Clinical Research Conference - 2009 East
  Miami, Florida, USA

• "Understanding Fair Market Value within the IIS Contract"
  June 8-9, 2009
  2nd Annual Forum on Investigator Initiated Studies & Grants
  Philadelphia, Pennsylvania, USA

Scheduled Training Sessions

• "Budget Management for Clinical Trials"
  March 24-25, 2009
  Philadelphia, Pennsylvania, USA

• "Devising Successful CRO Contracts"
  March 31 - April 1, 2009
  Philadelphia, Pennsylvania, USA

• "Budget Management for Clinical Trials"
  April 20-21, 2009
  San Diego, California, USA

• "Devising Successful CRO Contracts"
  April 23-24, 2009
  San Diego, California, USA

• "Budget Management for Clinical Trials"
  May 11-12, 2009
  Chicago, Illinois, USA

• "Devising Successful CRO Contracts"
  May 14-15, 2009
  Chicago, Illinois, USA

• "Budget Management for Clinical Trials"
  June 15-16, 2009
  Boston, Massachusetts, USA

• "Devising Successful CRO Contracts"
  June 18-19, 2009
  Boston, Massachusetts, USA

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Pharmaceutical companies face the daunting prospect of filling their pipelines as major drugs go off patent in the next few years. At the same time, pharmaceutical executives are concerned about declining R&D productivity and escalating costs, especially in the conduct of clinical trials. In order to manage development costs, increase access to relevant patient populations and better understand potential markets, pharmaceutical companies have looked for new geographies in which to conduct their research. The decision to include a specific country in a global clinical trial is influenced by a number of considerations, among which may be: similar medical treatments, longer term market attractiveness, patient access, timely patient enrollment, adherence to protocol processes & procedures, and the provision of quality data. However, relative costs between countries can play a role in the decision about which countries should be part of a specific clinical trial.

Global grant data in GrantPlan demonstrates that, while the declining value of dollar has brought Western European and North American to roughly comparable levels, especially in the case of the United Kingdom grant costs in key new research geographies remain substantially lower. Eastern Europe is still appreciable less than Western Europe. However, clinical grant levels in the geographies outside North American and Europe are significantly lower for comparable levels of clinical research activity. Effective clinical budgeting and clinical trial agreement negotiations require that sponsor companies and CROs understand relative payment levels in the various countries where clinical research is conducted, as well as the payment practices specific to each country. If you are interested in publications which highlight this research, please email reprints@ttc-llc.com.

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