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| About Veeda South East Asia (Malaysia) |
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Veeda SEA is a collaborative arrangement between Veeda and the Ministry of Health (through the Clinical Research Center – CRC) to open a Phase I and Early Clinical Development Unit at the Ampang Hospital in Kuala Lumpur. The CRC functions as clinical research arm of the Ministry of Health. It serves as a clinical trial support services to both public and private clients. It has 14 clinical centers in hospitals across Malaysia.
Dr Maurice Cross, Group Medical Director of Veeda CR, also noted that this would be a huge first for Malaysia. This would contribute to the training of Malaysians, and has the potential of attracting many pharmaceutical companies to evaluate Malaysia as a base in SE Asia.
Veeda is the only Phase-I CRO in Malaysia, with the closest competitors being in Singapore. Veeda will be pioneering Phase-I studies in the country. |
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| Bio Nexus Company |
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Veeda has attained the coveted Bio Nexus status for its operations in Malaysia.
The Bio Nexus status is granted by the Malaysian Biotechnology Corporation. It is the primary governmental development agency for Malaysia’s biotech industry. Their key responsibilities include identifying value propositions in R&D and commerce and support these ventures via financial assistance (by means of tax exemptions, grants) and developmental services, while giving firms the freedom of ownership and the freedom to bring in knowledge workers.
The Biotechnology Corporation is also the one-stop agency for gaining access to shared laboratories, and also for linking with other companies and facilities such as universities and research institutes. |
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| Why did Veeda choose Malaysia |
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Malaysia is a modern Asian Country with a total population of approximately 27mn people. Malays and Indians amount to 63% of the population and pharmacogenetically they are similar to Europeans. Chinese provide about 35% of the population. It delivers a high standard of modern health care to its citizens through a number of large general hospitals in the major towns and cities through National Health Service. Treatment is free at the point of delivery.
The Clinical Research Network was established for a centralized function and to provide a direct route for sponsors to gain access to clinical trial populations. Each hospital has a CRC Office specifically to act as the center of communication and feed-back information on patient availability. Participating centers may be large general hospitals or academic institutions. A list of investigators, all fully trained to GCP is maintained by the registry staff. Trials are initiated and controlled through the CRC. Lists of current trials are kept so that true availability of subjects can be ascertained. The CRC coordinates the regulatory process which is very client friendly and transparent. |
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| Location and Facilities |
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The Veeda facility would be located in a large general hospital, the Ampang Hospital, in Kuala Lumpur, which is the national center for hematology. The facilities in the ward are as under: |
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28 beds in total – 12 Monitored beds (GE Medical); 2 with invasive capability |
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Infusion pumps and drivers to beds |
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GE Medical ECG equipment linked to MUSE for TQT |
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In General Hospital with direct links to ITU and emergency facilities |
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Normal and patient populations |
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Quality Assurance / Quality Control, Project Management, Data Management and other support services are going to be provided through Veeda’s existing operations for the time being |
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| Regulatory Bodies and Timelines |
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| To perform a clinical trial in Malaysia, submissions are required to be made to the following bodies: |
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Medical Research Ethics Committee, MoH (Central EC) for approval via NMRR |
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CRC, MoH for review via NMRR (like MHRA – yet to confirm) |
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Drug Control Authority of Malaysia for CTIL (Clinical Trial Import License) |
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Submissions are in Parallel. On Line EC submission is via NMRR. The expected submission to approval time is 8-9 weeks currently if the submission package is complete. |
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| Required documents for submission in Malaysia include: |
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Full and final protocol |
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Investigator Brochure |
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Informed consent document |
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CV of Investigator |
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Clinical trial Agreement |
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Indemnity |
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Clinical Trials Import License |
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| Regulatory Authority Visits: |
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A number of Sponsor Audits |
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FDA and EMEA on 2 non-Oncology studies |
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None resulted in rejection of data from FDA |
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No critical findings; data has not been rejected by the FDA |
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| For new drug substances discovered in Malaysia or other countries, there is no law against FIM. Till date however, no study has been carried out in Malaysia. Veeda has decided that it will conduct easier trials initially before moving to FIM. The Plymouth ethics committee will be guiding their Malaysian counterparts in assisting FIM studies in Malaysia. |
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| Services to be Porovided in Malaysia |
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The company is going to provide the following services in field of research to pharmaceutical companies as well as other companies in case of their specific requirement: |
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Phase I to II |
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Oncology Studies at all phases |
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Bioanalytical services; Data Management services (through its facilities in India for now) |
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PK & Statistical analysis services (through its facilities in India for now) |
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It would include the process from discovery to conception till implementation, application.
Malaysia has one of the most sophisticated registries of disease in the world. Access to this registry provides for rapid and well targeted recruitment into clinical trials. This is an area which we will utilize for our oncology studies. It will be a priority area for development as increasingly there is a drive on the part of Pharmaceutical Companies to bring patient studies early into proof-of-concept studies immediately after first-into-man studies rather than completing the whole Phase I program and then going into a Phase II program. We are also in talks about the possibility of opening a joint biomarker laboratory in Malaysia to provide biomarker studies in oncology which will subtend both the human and the primate and higher mammal species from one laboratory platform. |
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| To know more about Veeda services or if you have any query please click here to contact us |
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