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When embarking on paediatric projects, clients often find themselves confronted with a scarcity of available data.
For over a decade, CDDI has been filling this gap by collecting real-world data on the paediatric population currently seen by expert clinicians at a representative sample of hospitals around the world in order to help clients prepare their Paediatric Investigation Plans (PIPs) / Pediatric Study Plans (PSPs) for approval.
If you need to make a strong empirical case to the Regulator, we can help you.
Our proprietary process, called Evidence-based Feasibility (EbF), provides data and analyses with a level of detail that is not otherwise available.
Clinical Leader from Large Pharma
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All PDCO requests regarding single arm open label design, cohort sizes and development timelines were resolved based on the EbF data.
Changes to the original design were all accepted by PDCO, including a waiver, based on the EbF data.
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Contact us to discuss how CDDI can help to:
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De-risk your Paediatric Investigation Plan / Pediatric Study Plan, preventing the need for amendments and ensuring timely completion.
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Negotiate your paediatric study commitment, by providing our regulator-ready reports.
