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Medical Technology  Features  Story
BioSpectrum Asia Pacific Awards 2009: GleneaglesCRC
Narayan Kulkarni

KokWeiYapGleneaglesCRC, a wholly-owned subsidiary of Parkway Holdings, is a regional contract research organization (CRO). Founded in late 1999 as a one person setup, GleneaglesCRC today conducts clinical research through its eight centers in Asia and with a network of 270 hospitals and more than 1000 investigators across the Asia Pacific region, it’s at the forefront for the recruitment of study subjects.

The key to GleneaglesCRC’s ability to be at the cutting-edge of clinical research is its access to its own doctors and hospitals within its parent company ParkwayHealth network, which comprises 15 hospitals across Asia. ParkwayHealth also paved the way for GleneaglesCRC to be associated with its collaborator hospitals in the region. As such, it’s an unparalleled network of sites, investigators and patients from which to draw on for clinical trials being conducted in the Asia Pacific.

With the purchase of Phase Forward’s Clintrial software for use in the Philippines as well as Singapore and China, GleneaglesCRC has positioned itself as one of the most technologically advanced CROs in Asia. It offers an entire range of services from full front-end services such as protocol writing, to back end services like statistical analysis. It has entered into partnerships with other organizations such as InfoKinetics in Malaysia for phase I studies, ICP Firefly in Australia for preclinical studies, regional regulatory consultant for Amgen and PhaseForward’s partner in Asia Pacific.

Achievements
The last couple of years were challenging and exciting for GleneaglesCRC as it worked on a large scale project in Indonesia, screening over 18,000 patients for non-respiratory diseases, and finally recruiting 2,000 into the study. Logistically, this project was challenging as it involved massive amounts of training and education for the staff involved, as well as dealing with the regulatory and ethics committee submissions for a project of that scale. The project also required the company to handle the massive amounts of data and accounting that was required. This is the largest clinical study to ever be conducted in Indonesia.

The study involved 11 hospital sites over four cities—Jakarta, Solo, Surabaya, and Padang. It involved a mix of pulmonologists and general practitioners, making up a total of 22 investigators, and 65 local coordinators. All the coordinators from the different hospital sites converged in Jakarta for a one-week training session. GleneaglesCRC worked closely with the inpatient registration office in each hospital site to obtain databases of all patients being admitted to the hospital on the morning of each weekday, and from this database, patients were screened for eligibility. In total, 18,661 patients were screened, and 1,681 patients finally participated in the study. Of these, 1,533 provided data that could be used for the purposes of the study. This entire screening and selection process took place within a very short eight-month recruitment period, making it all the more impressive. The final Clinical Study Report for this project was ready just one year after the recruitment ended—this was both a very large-scale and very efficiently-conducted clinical trial.

Last year, GleneaglesCRC received accreditation from Murdoch University in Australia, for its Good Clinical Practice (GCP) course. Its GCP courses were well recognized and GleneaglesCRC itself is credited for providing GCP training to Badan Pengawas Obat dan Makanan (Badan POM), the Indonesian National Agency of Drug and Food Control as far back as 2000. To capitalize on this strength, it met with Murdoch University officials in 2007, and collaborated on a university-approved training program resulting in GleneaglesCRC’s GCP course receiving accreditation from the University. Graduates from this course are awarded a joint-certificate of Good Clinical Practice from GleneaglesCRC and Murdoch University.

Along with the Malaysian Ministry of Health it has conducted a GCP course in Malaysia in 2008, and graduates received two certificates—one from GleneaglesCRC/Murdoch University, and the other from the Malaysian Ministry of Health. It also conducts a GCP workshop at each Annual International Meeting of Respiratory Care Indonesia (RESPINA). By conducting GCP courses it is creating job opportunities in the area of clinical trials and bridging the supply and demand gap for talents in this sector.

Besides its outstanding network, GleneaglesCRC also enjoys the advantage of having extensive experience in the Asia Pacific region, having conducted numerous clinical trials in many therapeutic areas, including infectious disease, gastroenterology, cardiovascular, endocrinology and oncology, in 12 regional countries. This wealth of experience has also enabled it to build up a solid track record in its ability to recruit patients from the various disease specialties and to build a strong relationship with the investigators and hospital administrators.

Future plans
During this economic recession, it appreciates the value of intensifying and expanding clinical research—particularly in the Asia Pacific region. GleneaglesCRC continues to work closely with many of the world’s most eminent pharmaceutical companies to help move drug development forward at an efficient and aggressive pace.

Backed by a solid experience of doing business in China, GleneaglesCRC has taken a lead to be the founder member of the CRO Union in China and is also an advisor to the Association of Pharmaceutical and Medical Devices of China, which falls under the Ministry of Trade. It is planning two ICH-GCP (International Conference on Harmonization of Good Clinical Practice) workshops to be conducted in Malaysia and Indonesia. This is in collaboration with Murdoch University. It is also working in collaboration with several American and European companies to conduct their clinical trials in the region. It is also mulling over a possible strategic expansion to Japan this year.

© BioSpectrum Bureau
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