Veeda Clinical Research and the Malaysian Ministry of Health have entered into a collaborative unit for a clinical trial in Kuala Lumpur. The Phase I and Early Clinical Development Unit in the Ampang Hospital at Kuala Lumpur will be located in one of the wards. It will be a 28-bed facility equipped to handle phase-I and Experimental Medicine Studies in select population. To begin with, there will be 12 fully monitored beds with telemetry and access to the MUSE digital storage system for electrocardiographic studies.
The Ampang Hospital is the principal Malaysian Centre for haematological disorders including oncology. A sterile suite for the preparation of injectables is available on site. All practical aspects of managing the clinical trials will be performed by Veeda's in-house team which includes project management, data management, statistics and Quality Assurance.
The company's large analytical facility in Ahmedabad will provide bio analysis and Pharmacokinetic services as required. The regulatory environment in Malaysia is modelled on the best practices established in Western locations with on-line application and tracking of clinical trials applications. The Malaysian Ethics Committee, experienced in clinical trials assessment, will provide an effective and rapid turnaround. There will be no issues on exporting samples to other countries.
The ministry of health in Malaysia has created Clinical Research Offices in all major hospitals which are linked to the extensive disease registries. The project was the brain child of Dr Teck-Onn Lim, a qualified nephrologist.
The development of a clinical research facility in the Ampang Hospital is the first move in a whole chain of activities intended to place Malaysia in the forefront of early Clinical Research in the ASEAN Area, stated Dr Lim.
Veeda Clinical Research was attracted to enter Malaysia to perform early clinical studies because of the talent pool support of physicians and scientists. Considerable support is also provided to the Malaysian Biotech Corporation to attract both service organizations and major pharmaceutical players.
"In our latest move, we will develop facilities for early clinical development studies to create credibility among the policy makers of contract research. Partnering with Veeda Clinical Research will enable knowledge transfer and technology growth. We will be leveraging on our infrastructure, strict regulatory environment and experienced investigators to position Malaysia as a preferred destination for all clinical trials," stated Dr Tan Sri, Director General of Health Services, Malaysia Government.
The Ampang Unit will provide a facility for the global pharmaceutical industry, said Dr Maurice Cross, group medical director of Veeda Clinical Research.