Anaheim, California (July 22, 2015) -- Anaheim Clinical Trials (ACT), an adult and pediatric Phase I through Phase IV clinical research center with full-service CRO capabilities announced that the company recently completed three, consecutive Japanese bridging trials in the last 6 months on biosimilar products.
In the first study, staff worked through the Christmas and New Year holidays. ACT randomized 147 Japanese (first and second generation) subjects in less than 90 days in a biosimilar study for a large biotechnology company. Initially a two-site study, ACT met the entire enrollment requirement of 132 subjects plus replacements with a 99% completion rate. “We continually excel, meet enrollment numbers and surpass timelines because of our dedication and teamwork,” said Jeff de Leon, MD, PTRP, CPT1, Director - Phase I.
The second biosimilar trial for a large biotechnology company started immediately afterwards. ACT randomized 48 Japanese subjects in 36 days with 47 subjects completing. In the third biosimilar Japanese trial, ACT was the highest enrolling site in a multicenter clinical trial, completing 22 subjects out of the total 32 subjects required in less than 90 days.
“I am so proud of the quality of work and dedication of the staff to our study participants and to our sponsors,” said Peter Winkle, M.D., F.A.C.G, F.A.C.P., C.P.I., Medical Director and Principal Investigator. “Because of the efforts of our team in meeting the timelines, as well as meeting the needs of our customers, our customers keep coming back.”
“We really appreciate the commitment of our study participants. We can have the best staff and the best facility, but without our study volunteers, clinical research could not be conducted. ” commented Jeff. One Japanese study participant wrote in an email [excerpt] to the ACT staff, “Anyhow thanks again for your professionalism and great service, I enjoyed my stay at ACT and will consider participating again, all the staff were friendly and well trained, I will let my friends know about this clinic and upcoming studies in the future. “
About Anaheim Clinical Trials:
Anaheim Clinical Trials (ACT) is an adult and pediatric Phase I-IV clinical research center, located in southern California (Anaheim). In addition to healthy volunteers, ACT has been particularly successful in enrolling special patient populations, such as renal- and hepatic-impaired patients, and Japanese subjects for ethno-bridging trials. Our certified Principal Investigators have the expertise and interest in a wide variety of therapeutic areas, including GI, pain, metabolic/inflammation, infectious diseases, and respiratory. ACT has been recognized by our customers for excellent quality research, timeliness, high patient enrollment, and ease of doing business. For more information, please visit our website at www.act-trials.com.
Anaheim Clinical Trials Contact:
Linda Gundaker, MBA, MT(ASCP)
Executive Vice President
Phone: (610) 937-2006
lgundaker@act-trials.com
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