Clinical Research Malaysia is committed to improve clinical trial infrastructure. Since conception in 2012, Malaysia has conducted 1600 Sponsored clinical research Phase 1B, 2, 3 & 4. There are more than 150 Clinical Research Sites and one thousand clinical trial investigators registered for multiple discipline of medicine. Similarly, the Clinical Trials conducted in the country delivered with speed, reliability & quality. The processes conducting Clinical Trial simplified with ISO9001:2015 accreditation.
The future of drug development is expanding into Phase 1A & First in Human (FIH). The Phase 1 Realization Project in Malaysia has concluded with two accredited, centers and recently the inaugural First in Patient Clinical Trial conducted in Sarawak General Clinical Research Center. There were two important FIH Guidelines produced & the establishment of Scientific Review Panel to advise Ethics Committee on the viable of FIH Clinical Trial.
The Government of Malaysia is supportive through the National Pharmaceutical Regulatory Agency, Medical Device Authority & Medical Research Ethics Committee consistent review timeline. In addition, the government recently announced Malaysia will develop its own vaccine. Hence it has sped up drug, vaccine, and medical device development in the country.
The speaker will share data on how the research environment in Malaysia transformed creating conducive environment for oncology clinical research. Consequently, achieving the National Key Economic Area Key Performance Index, with increased new jobs and number sponsored research conducted in the country. ¶