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Celgene verwendete SitePad® der PHT Corporation zur Erfassung elektronischer Daten über seine jüngst zugelassenen OTEZLA (Apremilast) Tabletten

Die Celgene Corporation verwendete das PHT Corporation SitePad® System zur Erfassung primärer und sekundärer Endpunktdaten für die Studie über sein Arzneimittel Otezla (Apremilast), das von der US-amerikanischen FDA im März 2014 zur Behandlung von Erwachsenen mit aktiver Psoriasis-Arthritis (PsA) zugelassen wurde.

PHT ist der führende Anbieter von Technologien, die zur Erfassung elektronischer Patientendaten für die klinische Forschung eingesetzt werden. Das PHT SitePad System beinhaltet ein großformatiges mobiles Tablet zur Erfassung studienspezifischer Beurteilungen von Ärzten und Patienten am Untersuchungsort. In StudyWorks™, dem PHT-Onlineportal zur Prüfung und Verwaltung der Daten, stehen alle gesammelten Informationen in Echtzeit zur Verfügung. Die Nutzung des SitePad Systems hilft, die Qualität der gesammelten Daten zu verbessern, Datenbanksperren zu verzögern und den Kosten- und Zeitaufwand der Überwachung zu reduzieren.

Die Sicherheit und Wirksamkeit von Otezla, ein oral einzunehmender PDE-4-Hemmer (Phosphodieasterase-4) wurden in drei klinischen Studien untersucht, an denen 1493 Patienten mit aktiver PsA beteiligt waren. Die mit Otezla behandelten Patienten wiesen im Vergleich zur Placebogruppe Verbesserungen bei den Anzeichen und Symptomen der PsA auf, zu denen geschwollene und schmerzempfindliche Gelenke und physische Funktionseinschränkungen gehören.

Philip Lee, der President und CEO von PHT, sagte: „PHT ist geehrt, an diesem Entwicklungsprogramm beteiligt gewesen zu sein, das als ein Erfolg für Celgene und Patienten mit PsA in aller Welt abgeschlossen wurde. Die Mitglieder des PHT-Teams, die an diesem Projekt mitarbeiteten, empfinden sowohl persönliche als auch berufliche Genugtuung, dass sie zur Markteinführung dieses wichtigen neuen Therapiemittels beigetragen haben.“

Über die PHT Corporation

Als Innovator elektronischer Systeme für die klinische Forschung schreitet die PHT Corporation bei der Einführung patientenorientierter mobiler Anwendungen voran. Das eCOA-System (electronic Clinical Outcome Assessment) von PHT zur elektronischen Beurteilung klinischer Ergebnisse sammelt und übermittelt sichere Patientendaten in Echtzeit von den modernsten mobilen Endgeräten. Die wissenschaftlichen, regulatorischen und technologischen Kompetenzen von PHT in Verbindung mit qualitativ hochwertigen Ergebnisdaten versetzen die Kunden in die Lage, fundierte Forschungsentscheidungen zu treffen. Studienträger und Auftragsforschungsinstitute haben die PHT Patient Suite in mehr als 650 Studien eingesetzt, die zu über 16 regulatorischen Zulassungen führten. Weitere Informationen über PHT finden Sie unter www.phtcorp.com. Folgen Sie PHT auf LinkedIn, Twitter, Google+ und YouTube.

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