Phase Bio Case Study

PhaseBio Adopts Medidata Platform for Initial Single Site Phase I Treatment of Orphan Diseases

Learn Why You Should Consider Medidata for Small Phase I Studies

Phase Bio Case Study

PhaseBio, an emerging and innovative biotech company, is one of 1,200 sponsors that have adopted the Medidata Clinical Cloud. PhaseBio is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies to treat orphan diseases, with an initial focus on cardiopulmonary indications.   Their lead product candidate is PB2452, a novel reversal agent for the antiplatelet drug ticagrelor.

Medidata Rave was used during the Phase I trial for PB2452, which was granted ”Breakthrough Therapy” designation by the FDA.  This designation for PB2452 was supported by Phase 1 trial results, in which PB2452 achieved an immediate and sustained reversal of ticagrelor’s antiplatelet effects.

Read the case study behind their decision to use Rave EDC beginning with initial Phase I study — and plans for future scalability as their programs grow.