PRC Clinical continues to apply its expanded workforce, technologies and expertise in its focus on Phase II and rare disease indications.
PRC Clinical™, a Contract Research Organization (CRO) in the San Francisco Bay Area providing full-service clinical trial management services, announced today that it has been awarded a Phase IIb study in an orphan-status therapeutic indication. Enrollment is expected at more than 50 study centers in the US and Canada.
“PRC Clinical is delighted to have been selected as the CRO on this global trial. It is a testament to our growth, leading-edge technologies and more importantly, our commitment to our sponsors in the development of life-altering treatments that impact patients and their caregivers” said PRC Clinical Co-Founder and President, Curtis Head. “Our years of trial experience and with orphan designations, assures our sponsors of the quality of our services and the value of a well-managed trial with accurate data”.
About Orphan Designation and Phase IIb Design
In the United States, orphan designation may be granted by the FDA for drugs and biologics treating disease conditions affecting less than 200,000 individuals and where development costs would not be expected to be recovered by product sales revenue in the US. Companies developing treatment for orphan diseases may receive federal assistance throughout the development process, sales exclusivity and certain tax credits. Orphan designation is not an indication of a drug’s safety or effectiveness and must still go through the trial approval process.
The phase IIb trial design, while maintaining a focus on safety may more rigorously define and target dose ranges and routines. In contrast to phase IIa studies, IIb designs are generally larger, well-controlled trials that often include 300 or more patients in the treatment, diagnosis or prevention of a disease.
About PRC Clinical™
PRC Clinical is a CRO in the San Francisco Bay Area committed to delivering world-class quality and client satisfaction by providing personalized clinical services to pharmaceutical and biotechnology companies.
PRC Clinical project teams are highly skilled and experienced clinical professionals; Services include Project Management, Regional Monitoring, Data Management, Electronic Data Capture (EDC), Biostatistics/IRT, Central Laboratory Services and Global Clinical Payment Services. PRC Clinical has experience in conducting all phases of studies, including Registries and orphan/rare disease studies and in a wide range of disease, delivery and therapeutic areas.