CRM is a non-profit organisation, formed as an Entry Point Project 2 (EPP2) under the National Key Economic Area (NKEA). It was previously a unit under Clinical Research Center before it was corporatized into a separate entity on 15 June 2012. It runs as a private company, however it is fully government owned and the members of the Board of Directors are government officials. CRM’s vision is to make Malaysia the preferred destination for clinical trials. Its Key Performance Index is to have 1000 ongoing trials in Malaysia by year 2020
CRM was formed as a one stop centre for Industry Sponsored Research in Malaysia. It functions as facilitator for all things related to Industry Sponsored Research and liaises with the government, sponsors, CROs and Investigators on various levels. CRM drives the success of ISR Clinical Trials by
CRM strives to smoothen the process of clinical trials for the Investigator at all levels.
No, CRM functions as an independent entity which facilitates Clinical Research at all levels and adds value to the procedures already in place (as mentioned in Question 3).
|Previously a unit under CRC, but was corporatized in 2012||Formed since 2000|
|Facilitates Industry Sponsor Research (ISR)||Facilitates Investigator Initiated Research (IIR)|
|Provides Study Coordinators for ISR||Provides Study Coordinators/Contractual Workers (“”Pekerja Sambilan Harian) for IIR|
|Receives and executes disbursement of sponsor’s study budget based on Principal Investigator’s intent||Does not handle trial budgets except when payment is transferred from CRM into CRC Trust Fund for payment to MOH Staff|
|Corporatised Private Entity (owned by government)||Government Unit|
|Headquarters at Amcorp Business Suites, Petaling Jaya||Headquarters at Hospital Kuala Lumpur|
Industry Sponsored Research (ISR)
Investigator Initiated Research (IIR)
|Topic of research decided by Pharmaceuticals||Topic of Research decided by Specialists themselves|
|Usually involves drug development||Involves topics on registered drugs/epidemiological/behavioral topics|
|In Malaysia, overseen by CRM||In Malaysia, overseen by CRC|
|Study Coordinators may be supplied by CRM||Study Coordinators may be supplied by CRC|
|Multicentre||Can be single site or multicentre cooperation|
|Involves feasibility||Does not involve feasibility|
|Publishing rights are determined by sponsor||Publishing rights go to the specialists involved|
|Funds from Sponsor||Grants from Government (MOH/MOHE/MOSTI etc) or Trust Funds|
Both require Investigator and staff to be GCP qualified
No, you may choose to follow the previous procedure at any time, i.e. you may go through society and manage the study on your own. However, with reference to the circular signed by the Director General of Health on 6 November 2012, the 15% management fee is still to be paid by sponsor to CRM. This will replace the 15% institutional overhead charge previously paid to NIH.
No, CRM does NOT take 15% of the trial budget. 15% will be allocated by sponsor on top of the 100% trial budget, making it a total payment of 115%. 100% goes to the trial budget and 15 % goes to CRM for running costs (management fee).
Before the corporatisation of CRM, the additional 15% was paid by the sponsor to NIH as an institutional overhead charge. The 15% to CRM has replaced the one to NIH, thus there is no additional cost to the sponsor.
For specific details on the flow of trial budget management, you are welcome to contact the Head of Clinical Operations / Senior Research Manager.
Yes, you can hire your own study coordinator instead of using CRM’s. If your Study Coordinator is hired by CRM, his/her salary will be paid by CRM and the amount allocated for him/her in the trial budget will be deducted by CRM. If you hire your own Study Coordinator, the allocation for his/her salary will be from the trial budget.
In Industry Sponsored Research, feasibility studies are created by the Sponsor. As indicated by the name, feasibility studies are conducted to find out if an upcoming clinical trial is feasible in the targeted site (e.g whether there is a good patient pool, adequate facilities and manpower etc). It is conducted by disseminating a feasibility questionnaire to the doctors for completion. It is the first step to bringing an ISR clinical trial into a site, as it is from the feasibility answers that the sponsor will decide whether to pick a site for the trial.
The site selection process carried out by sponsor is usually completed many months from the date of feasibility deadline (estimated at least 5 months, but duration varies based on sponsor). As this is a multicentre trial, globally held and coordinated, they will take time to compare the feasibility results of all the countries approached and make their decision. At CRM, we strive to follow-up with sponsor’s decision of selecting sites to understand the reasons for site selection and non-selection.
There are many reasons for selection or non-selection of a site. Not all sites that responded positively in the feasibility questionnaire are selected. Some of the main reasons cited by CRO are lack of patient pool and facilities on site. If you would like to know the results or progress, you are most welcome to contact the person who approached you for the study, whether a CRM staff or CRA.
In ISR, the feasibility deadline is set by the sponsor as a globally coordinated deadline. If there is any delay in submission, the Investigator runs a risk of not being considered for the selection process.
There are a few ways to make filling a feasibility questionnaire faster and simpler and at CRM we aim to put these practices into place. We strive to send the questionnaire directly to you personally in a short time span convenient to you. As long as you allow it, the CRM staff sent to you will introduce the study and answer any questions you may have on the spot. If there are questions that you feel should be answered by other departments such as Pharmacy/Laboratory/Imaging etc, they will help to obtain their answers to complete the questionnaire. If there are parts of the questionnaire where the CRM staff can answer on your behalf, they will do so (such as questions on storage space, your professional details including hospital and hospital address etc).
If there is currently no CRM staff stationed at your site, we will email you the protocol and contact you via mobile in your free time to discuss on it.
Ultimately the goal is the same, that is to bring the feasibility to you and to get valuable feedback (both positive and negative) on a study. The CRA may choose to contact you directly or to go through CRM. Either way, your feedback is returned to the CRA in charge and they will relay it to the sponsor.
There are many benefits from doing Industry Sponsored Research and the benefits will not only be enjoyed by you but also the people around you.
Benefits to the Investigator
Benefits to the Patient
Benefits to Hospital and Hospital Staff
In summary, there is currently very good ground laid out in Malaysia to carry out Industry Sponsored Research. There is strong support by the Government and CRM was set up to help in many aspects. However it all comes down to the Investigators – You are the leaders and decision makers on the conduct of Clinical Trials, and you have the power to bring in all the benefits that Clinical Research offers to Malaysia.
The National Pharmaceutical Control Bureau. The specific unit in charge within the Bureau is the Centre for Investigational New Product
The SOPs and guidelines are available in the National Pharmaceutical Control Bureau’s website at http://portal.bpfk.gov.my/index.cfm?menuid=69.
A sponsor or CRO without an office in Malaysia can outsource this application service to any local or locally-based CROS/SMOs in Malaysia. CRM will international CROs that has no base in Malaysia, with local CROs so their trials can be conducted here.
The documents needed are as follows:
A representative from the sponsor or CRO such as a Clinical Research Associate. The application form must be signed by a Licence A holder for ‘poison/drug’. Holder of the CTIL/CTX need not necessarily be the one who conduct the trial.
A complete application without queries can be approved within 30 working days.
Yes, the processing fee is approximately USD170 per product.
Yes, the guideline is available online at www.bpfk.moh.gov.my
There are 13 such ethics committees. Clinical trials conducted at these site have to be approved by the respective ethics committees. The list is as follows:
1. Hospital Universiti Kebangsaan Malaysia (HUKM)
2. Hospital Universiti Sains Malaysia (HUSM)
3. Institute Jantung Negara (IJN)
4. International Medical University (IMU)
5. Joint Penang Independent Ethics Committee (JPEC)
6. Ministry of Health Medical Research and Ethics Committee (MREC)
7. Sime Darby Medical Centre (SDMC)
8. Sunway Medical Centre (SMC)
9. Universiti Islam Antarabangsa (UIA)
10. Universiti Teknologi MARA (UITM)
11. University Malaya Medical Centre (UMMC)
12. Universiti Putra Malaysia (UPM)
13. USM – Lam Wah Ee
The Ministry of Health Medical Research Ethics Committee (MOH MREC) handles applications for clinical trials conducted in all MOH hospital sites. This committee meets twice monthly. The schedule is available at www.nih.gov.my
Applications can be submitted online through the National Medical Research Register (NMRR: www.nmrr.gov.my). The Principal Investigator and all sub-investigators must be registered with the NMRR. The CRA can do the registration for the Principal Investigator, who then can log in to change the password.
Yes, there is a guideline which can be downloaded from www.nmrr.gov.my.
Please email a request to the MREC Secretariat at firstname.lastname@example.org
Yes, it has to be in English, Bahasa Malaysia and Mandarin, and in Tamil where required.
These can be submitted online as well.
A complete submission without queries can be approved within 4 to 8 weeks
None at the moment.
If you have any queries, please contact us at:
MOH Medical Research Ethics Committee (MOH MREC)
Ministry of Health Malaysia
c/o Institute for Health Management
Jalan Rumah Sakit Bangsar
50900 Kuala Lumpur, MALAYSIA
Tel: +603 2282 9082/9085
Fax: +603 2287 4030