The Center for the Study of Drug Development (Tufts CSDD), an independent, academic, non-profit research group at Tufts University School of Medicine, is conducting phase two of its well-known protocol amendment study. We welcome your participation.  We're looking to update our analysis of the incidence of protocol amendments and to understand which amendments are preventable. Additionally, we will quantify the direct and indirect costs associated with amendments. Lastly, we will look to highlight strategies that biopharmaceutical companies are using to reduce the number of amendments and benchmark the impact of these strategies.


Your input is very important to us.  We're planning to form a working group of more than 20 biopharmaceutical companies to participate in the design and execution of this study as well as to assist in the interpretation of the results.  No financial contribution is required to participate.  We ask all participating companies to contribute their time and data to the study.  In exchange, Tufts CSDD will provide each company with a personalized report of your company's results compared to the aggregate results at the conclusion of the study.


If you have any questions about the study or would like to participate, please contact Stella at (617.636.0322).


Thanks in advance for your help on this important study and we hope that you'll join us as a participant!

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