Best Practices In FDA Orphan Drug Submissions

Since 1983, pharmaceutical developers have been incentivized by the FDA via an Orphan Drug Designation (ODD) program. The program awards orphan status to drugs that show likelihood of benefitting an afflicted population that might not otherwise be the focus of development efforts.
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7 trends in clinical trial data

Clinical trials are incorporating data from so many more sources today: genomic sequencing, medical imaging data, lab data, wearable sensor and other mHealth data. Today’s clinical research requires a technology platform that can ingest and integrate data from any data source.
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