Case Study

Complex Hematology/Oncology Trial Operating In The New SIA Model

Source: PPD

In Q4 2012, PPD was awarded a full-service, Phase III hematology/oncology project by a small US-based pharmaceutical company (client) who partnered with a large biopharmaceutical company (funding partner) for joint development and funding. This was PPD’s first award with this client, although many of its executives and managers worked with PPD at previous companies and PPD has extensive experience with its larger funding partner.

The PPD award was conditional on achieving several critical operational milestones for enrollment and data cleaning, each tied to a combination of development timelines and funding milestones. After careful internal evaluation, PPD agreed to the conditions and received the client’s agreement for an assertive plan for selecting sites, managing the regulatory submissions and negotiating site contracts and budgets.

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