CASE STUDY Multi-stakeholder Collaboration Achieves Rapid Study Start-up for an Advanced TherapeuticPrimary Endpoint Product safety PRA Services Full Service Drug Class Live Biotherapeutic Study Phase Phase I/II Regions North America STUDY DESCRIPTION PRA worked with an emerging biotech firm to implement a first-in-human clinical trial using a live biotherapeutic product for a rare disease indication. Study Duration 12 months No. of Clinical Sites 6 Patient Population Healthy volunteers and adult patients diagnosed with a rare disease PRA identified a lack of clinical research experience at the site level with this specific type of product categorization. Sites were confused as to the appropriate regulatory, ethics, and safety review processes required to initiat

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