At the recent National Conference for Clinical Research held in Penang, Malaysia, Veeda Clinical Research and the Malaysian Ministry of Health announced the opening of Veeda’s office in South East Asia and a collaborative agreement with the Malaysian Ministry Health to open a Phase I and Early Clinical Development Unit in the Ampang Hospital in Kuala Lumpur. The Unit, in one of the hospital’s wards, provides a 28 bed facility equipped to the highest standards for Phase I studies and also Experimental Medicine Studies in selected populations. The unit will have initially 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 and especially haematological oncology as well as providing a full general clinical service to the local district. 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 teams and will include project management and data management and statistics and Quality Assurance. It is intended that as the unit grows, more services will be provided locally from within Malaysia. The large analytical facility already working in Ahmedabad will provide bio analysis and Pharmacokinetic services as required. The regulatory environment in Malaysia is modelled on the best practice in established Western locations with on-line application and tracking of clinical trials applications and there are no issues with the exportation of samples for all needs to external countries. The Malaysian Ethics Committee is well established, experienced in Clinical trials assessment and provides an effective and rapid turnaround.

With considerable foresight, the Ministry of Health in Malaysia promoted the formation of Clinical Research Offices in all major Malaysian Hospitals. These offices are linked to the extensive registries of disease which provide a most valuable resource for clinical researchers wishing to come to Malaysia. The Clinical Research Centres of the Malaysian Health service are directed by Dr Teck-Onn Lim – a nephrologist by training, who was the driving force behind the registry system. Dr Lim said that ‘ 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’

Veeda Clinical Research was attracted to enter this highly significant and ground breaking arrangement with the Ministry of Health because of the clear advantages of Malaysia as a place to perform early clinical studies and the large pool of talent within the population of Malaysian physicians and scientists. Additionally the huge drive provided by the Malaysian Biotechcorp to attract both service organisations and major pharmaceutical players to Malaysia was a significant factor in driving this relationship.

The Director General of Health Services, Tan Sri Dato’Seri Dr Haji Mohd. Ismail bin Merican who is a distinguished hepatologist commented…..’ In our latest move up the research value chain, we will develop facilities for early clinical development studies locally to raise Malaysia’s profile and credibility amongst the policy makers of contract research. It will be a steep learning curve and to ensure that we will be able to face the challenges ahead, we have carefully selected partners such as Veeda Clinical Research to enable knowledge transfer and technology growth. We will be leveraging upon our considerable infrastructure, strict and robust regulatory environment, and trained and experienced investigators to position Malaysia as a preferred destination for All Clinical Trials’

Dr Maurice Cross, Group Medical Director of Veeda Clinical Research observed that the opening of the Ampang Unit towards the end of this year will be a huge first for Malaysia. It will provide not only a facility for the Global Pharmaceutical Industry but will also be a major contributor to the training of a cadre of Malaysians capable of performing this type of work and will also play its part in attracting many Pharmaceutical companies to look at Malaysia as a base in SE Asia.