What are your job functions as the Head of Finance and IT?
My main job functions are to monitor the daily operation of the department to ensure its smooth running and to work with other departments which involves Finance and IT related matters.
What are the services offered by the Finance and IT department of Clinical Research Malaysia (CRM)?
Among the services offered by CRM under this department include management of the clinical trial budget for Principal Investigators (PI), assist sponsors and contract research organizations (CROs) and PIs in budget negotiation and any ad hoc matters involving these stakeholders.
What is CRM’s role in managing a clinical trial budget?
CRM acts as a trustee in managing a clinical trial budget by receiving and executing disbursement of a trial budget. Upon receiving a Payment Instruction Form from a PI, CRM releases payment to the relevant recipients (for purposes of patient reimbursement, lab tests/procedures, outsourcing services to vendors, investigators’ fees, etc). CRM pays the PIs directly instead of re-routing through the CRC Trust Account in HKL. This has shortened the payment timeline to less than 2 weeks. Apart from that, CRM ensures that a monthly Statement of Account is issued to the relevant Principal Investigators.
How can CRM assist Principal Investigators with their clinical trial budget?
CRM, on behalf of the Principal Investigator (PI), can assist in negotiating a trial budget (as part of the clinical trial agreement) with a sponsor or CRO. CRM ensures that the fees paid are according to the current industry standards and fair market value, and will advise PIs if any fee needs to be revised. During the review of a trial budget, CRM ensures that all core components of a trial budget are addressed.
Can you share with us how CRM utilizes the 15% management fee that is charged to the CROs and sponsors and how does this benefit the local sites conducting clinical trials?
The 15% management fee is used for various initiative including:
- To invest in developing the capability of sites through the purchase of medical equipment related to clinical research and upgrading of the internet facilities.
- Sponsor PIs and the clinical research team to attend conferences and training for professional development and to upgrade their knowledge and skills.
- Provide human resources to the Medical Research Ethics Committee (MREC) and Medical Device Authority (MDA) to smoothen the application process of ISR studies.
- To promote Malaysia as the preferred destination for clinical research at national and international conferences.
Why is it important for CRM to manage the trial budget?
CRM is authorized by the Malaysian Government to handle clinical trial budgets that are conducted in Malaysia. It is the role of CRM to ensure that payments are made to the relevant parties involved in the conduct of clinical trials and that it is made in a fair and transparent manner. According to the General Orders, Chapter D (Article 5), an Investigator, being a government officer, shall not receive money paid directly to him/her derived from his/her clinical trial activities. In light of this, CRM legitimizes the transfer of trial funds by managing the trial budget and channeling the investigators’ fees to the relevant PIs.
Is study payment subjected to GST?
No, it is not subjected to 6% GST because the study payment is not a source of revenue or income for CRM. However, if the PI chooses to use outsource services, 6% GST will be charged if the vendor is a GST-registered company with the Royal Malaysian Customs Department.
Which fees are subjected to GST?
CRM’s study coordinator fees, archiving fees, imaging costs, laboratory fees and any other outsourced services used by the PI.
What do you enjoy most about your job?
The recognition by the industry that CRM is here to assist the clinical research industry as well as the opportunity to learn together with the stakeholders and key opinion leaders.
And the most challenging part of your job?
There are always new challenges. The most challenging part of it would be executing something which is beyond my control while testing my ability to overcome it.