It is very important that the TZA be written in a language that is understandable to all parties. It must be clearly written by limiting and defining all legal concepts used. Sponsors and CROs have the same interests with regard to clinical trials that are: Malaysia`s current Economic Transformation Program (ETP) targets clinical research as one of their main drivers of economic growth. In order to regulate the behaviour, relationships, responsibilities and obligations of the clinical trial parties, the Clinical Trial Agreement (CTA) must be in effect. Parties to a CTA are generally not limited to sponsors or contract research organizations (CROs), but also include institutions and lead investigators. The Malaysian Guideline on Good Clinical Practice defined the CTA as “a written, dated and signed agreement between two or more participating parties that defines all agreements for the delegation and allocation of tasks and commitments and, where appropriate, in financial matters. The protocol can be used as the basis for a treaty. (1) To date, Malaysia has 66 SRI test sites, approved by the Ministry of Health (MOH), which consist of a merger of public and private hospitals. To date, they have participated in more than 1000 SRI studies. By the end of 2014, 202 new SRI studies had been approved by the Institutional Audit Committee (IRB).

CRM aims for 230 new studies for 2015 and its vision for 2020 is to carry out 1000 studies underway in Malaysia. 5. A.J.A. Ooi, K.F. Khalid, MD, January 26, 2017, Malaysia`s Clinical Research Ecosystem ( Clinical Trial Exemption (CTX): authorization to manufacture products/S exclusively for the production of samples for clinical trials. [3] [6] On the other hand, from the perspective of the suburban clinical trials, their interest lies in compliance with protocol and rules, including: George Clinical Malaysia was founded in 2009 and has since implemented some of our largest programs. George Clinical Malaysia, based in Kuala Lumpur, also includes neighbouring Southeast Asian countries such as Singapore and Indonesia. We have established networks of cardiovascular, diabetic and kidney researchers in this multiracial country that invests heavily in improving its profile as a clinical research goal.

Malaysia is one of the most popular coastal tourism countries in the world, known for its culinary sensations, beautiful beaches, idyllic islands and national parks. But do you know that Malaysia has a powerful health system and can be a privileged country for your clinical trials? In order to ensure a short timetable for the CTA review, a fixed 14-day schedule is put in place so that the site visit can follow as planned as part of the protocol. All CRM legal employees hold a timeline tracker to ensure that the 14-day schedule framework is met for a CTA audit. However, it is still the subject of budget negotiations between all parties, as the clinical trial budget is included in the ATC. (b) In 2015, the CRM`s Legal and Regulatory Affairs Department developed an online CTA verification system that accelerated the CTA`s audit days from 59 to 13. The online evaluation system was introduced in March 2016. The online system is our own internal system purchased, where all CTAs are submitted for the websites of the Malaysian Ministry of Health, especially for industry-sponsored research, by the clinical research assistant of sponsors and CROs for review of the legal and regulatory department of the CRM in the system.