CRM’s Pilot Training Programme: Fundamental of Clinical Research & Practice

The Fundamental of Clinical Research & Practice, it’s CRM’s pilot training programme together with C&R Research Inc. (Korea). This 3 days training are packed with all-you-need-to-know about conducting clinical trials.

In our journey to be the global preferred site for clinical trial, we will need to equip our people with global standard practice in clinical research.

This is one of many trainings that we have in the pipeline and stay tuned for more future programmes conducted by CRM.

About This Training:
The Fundamental of Clinical Research & Practice Course is an introductory training that provides the fundamental information to understand clinical research. It includes Overview of Drug Development, Non-Clinical study, Trial Phases involved and the objective of every phases. The course will also cover the most important guideline in conducting clinical research, Principles of Good Clinical Practice and brief discussion of Roles and Responsibilities of players in clinical research (Institutional Review Board/ Independent Ethics Committee, Investigators and Sponsor).

NHAM-CRM Research Track 2018

This is the 2nd NHAM-CRM Research Track organized by Clinical Research Malaysia (CRM) in collaboration with the National Heart Association of Malaysia (NHAM) and Malaysian Society Pharmacology and Physiology.

We are honoured to have with us today, Datuk Dr Shahnaz Murad (Deputy Director-General of Health (Research & Technical Support), Ministry of Health Malaysia) to officiate the NHAM-CRM Research Track at the NHAM 2018 Conference. Welcoming speech was given by Dr. Akhmal Yusof (CEO of CRM) followed by Dr Ng Wai Kiat (NHAM President).

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Canvassing: Recruitment of Patients with Rare Condition in Clinical Trials – Sharing Experience from our Perspective

By Ranita Kirubakaran (Clinical Pharmacist, Hospital Sultan Abdul Halim, Kedah), Vijaya Kumar L. Suppan (Head of Orthopaedic Department & Clinical Research Centre, Hospital Sultan Abdul Halim, Kedah)

 

Acute hematogenous osteomyelitis (AHO) is an inflammatory disorder of the musculoskeletal system and mainly, a disease of growing bones. It is a common invasive infection in paediatric and the incidence is 8 cases per 100,000 children/year [1, 2]. In children, osteomyelitis (OM) arises from bacteremic seeding of the bone metaphysic [3]. Primary bones affected are femur, tibia, humerus and less frequently, pelvis and vertebra [3]. Staphylococcus aureus is the most common pathogen, causing between 25 – 60% of cases with known etiologies [4, 5, 6].   Other causative bacteria include Streptococcus pyogenes (Group A streptococci), Kingella kingae and Haemophilus influenza type b [4, 5]. Children are treated empirically with intravenous (IV) therapy directed against the likely pathogen and then, guided by culture results with continued IV or oral therapy. Read more

CRM on Astro Awani’s Smart Money with Ibrahim Sani (VIDEO)

Astro Awani’s Ibrahim Sani interviewed Dr. Akhmal Yusof (CEO of CRM) on his show Smart Money where he shares about the landscape of clinical trials in Malaysia & why participation in a clinical trial is important to the development of new advance medicine or treatments. The show also highlight about Clinical Trials Day recently held at the Institute Kanser Negara (IKN) on 16th May 2017. A must watch interview!

A Day in The Life of A Study Coordinator

By Matron Lim Chooi Eng, CRM, Hospital Pulau Pinang (HPP)

 

I have always thought being a study coordinator is nothing short of the ordinary. I had done many research papers and had also been involved in many investigator initiated research papers during my nursing days and I was very confident of myself.  I was so confident of myself that I included all the abstracts of the studies that I had previously done in my folio when I went for the interview with Matron Wakia at CRM office. Read more

Working Abroad in Clinical Research

Ms Shantini Chelliah
Project Manager at Novo Nordisk,
New Jersey, US

Ms Shantini Chelliah shared her experience with CRM in her previous role as a Clinical Operations Manager at Novo Nordisk Malaysia and her current role as Project Manager in Princeton, New Jersey, US.


How did you start off in the clinical research industry?
I started off as a CRA in GlaxoSmithKline and then moved to a Clinical Team Lead role in Quintiles before assuming my position as Clinical Research Manager and then Clinical Operations Manager at Novo Nordisk Malaysia. I am now a Project Manager within Clinical Trial Management in Novo Nordisk Inc. in the US.

What does a Clinical Operations Manager do?
Clinical Operations Manager (COM) is responsible for the operations and deliverable of trials and is the main contact for any general queries and issues with regards to change of regulations governing clinical trial conduct in Malaysia. As a COM, I was also responsible in overseeing the trials selection process, that would ultimately be allocated to Malaysia, ensuring that they can be done in Malaysia, coordinating feedback from various stakeholders in Malaysia, and our HQ. I was also responsible for approving the sites that were selected for our trials and providing accurate data on utilization of resources for Clinical Trials in Malaysia. I was responsible along with my manager and our HR in the hiring process for clinical team members in Malaysia.

How long have you been in Novo Nordisk before moving to the US to take up the position as Project Manager?
6 years

When told about this offer to move to the US, how did you react?
I was very excited about this opportunity. I had never been to the US before and I have never worked outside of Malaysia, so this was a chance for me to build my career and experience living abroad. As Clinical Trials in the US are managed differently being a much bigger country, I was happy to be able to learn new processes especially in terms of resource management.

What do you enjoy most about your job?
I love being hands on with my projects. I enjoy listing out risks and opportunities and meeting new site staff whenever I have the opportunity. I love to be one step ahead of whatever challenge I may receive! I love travelling as well.

Read more contents from CRM Bulletin Issue 9. Download here!

And the most challenging part about your job?
For now, my challenge is to understand and integrate the different roles and how they work together here as we were leaner in Malaysia. Tasks are handled quite differently here than what I am used to.  I am learning new things every day, but having a good core understanding of trial management helps. As a former line of business manager, I am trying hard to ease my manager’s burden by learning quickly so I can be more independent! My manager and colleagues have been a source of true support in helping me do my best.

What would be your advice to those who are looking at developing their career in the clinical research industry?
Make the most of every opportunity to learn something new. You just never know where it may lead you.

A Day in the Life of a Senior Feasibility Specialist, Clinical Research Malaysia

What is a clinical trial feasibility and why is it important?
I believe that Feasibility Studies are the gateway to bringing more clinical trials to Malaysia. It is not only a tool to assess whether a trial is possible in Malaysia but it is also a method to promote that possibility to International companies which may not yet be familiar with Malaysia’s capabilities. From a Sponsor’s perspective, it is important to conduct feasibility studies before investing on a trial in Malaysia so Sponsors would ultimately decide whether or not to place their trial in Malaysia. Sponsors need to assess a myriad of factors such as timelines, cost effectiveness, challenges foreseen, patient pool and equipment availability before coming to their decision.

What are your job functions as a Senior Feasibility Specialist in CRM?
I handle pre-feasibility enquiries and full feasibility studies besides arranging meetings with Investigators and CROs. I also maintain our internal databases and coordinate the team’s efforts in growing the database.

What are your job functions as a Senior Feasibility Specialist in CRM?
I handle pre-feasibility enquiries and full feasibility studies besides arranging meetings with Investigators and CROs. I also maintain our internal databases and coordinate the team’s efforts in growing the database.

How many are there in the feasibility team and how is work divided between the team?
Currently there are three of us in the team, including myself, under Business Development. We drive feasibility and discuss technical aspects with Investigators and the industry. We accept requests and enquiries across all clinical therapeutic areas, from medical to surgical, from investigational drugs to medical devices. For the 6 major therapeutic areas of clinical trials in Malaysia, we have each been assigned our own areas to oversee in more detail. I oversee Cardiology and Respiratory, Gurinder oversees Haematology and Endrocrinology while Zaihan oversees Oncology and Gastroenterology.

How has the feasibility process in CRM developed over the years?
It has been through a big leap since the early years. In the beginning, a lot of our work was done with Microsoft Office alone. In 2015, we developed an internal system with our vendor which can enable more organized capture of data, which in turn saves time and allows the Feasibility Specialists to take up more projects at a time. We also developed our internal database of Investigators, to map out each therapeutic area available for clinical trials. Our CEO, Dr. Akhmal, saw the important role of feasibility in bringing clinical trials to Malaysia and grew the team to three. With the development of our system in 2015 and the enactment of a new SOP to incorporate that system, CRM saw an increased uptake of full feasibility from 58 in 2013 and 59 in 2014, to 80 full feasibility projects in 2016 (35% growth). The number of CROs and Sponsors engaging CRM for enquiries saw an increase from 16 to 48 companies (300% growth) in 2015, majority of which are international companies.

Can you describe what happens when a feasibility request comes in.
We receive many types of requests, and we generally categorise them into Non Feasibility Enquiries, Pre-feasibility enquiries and Full Feasibility Studies. A Sponsor or CRO would email us an enquiry and we act to achieve the objective of that enquiry. Non-Feasibility enquiries are not related to any particular study or therapeutic area, such as overview on the Malaysian landscape, which companies to contact for indemnity or which CROs a Sponsor can approach for engaging monitoring and startup activities. Pre-feasibility enquiries involve preliminary questions leading up to the decision whether or not to conduct full feasibility studies in Malaysia. These can include Standard of Care, drug registration status, epidemiology and estimated patient pool of a particular therapeutic indication. Full feasibility studies involve approach of individual sites to ascertain interest in a specific study and a more specific patient pool.

For pre-feasibility enquiries, our standard timeline is 1-3 working days for shorter enquiries and 3-5 working days for longer enquiries. For full feasibility, our timeline is 5-7 working days unless otherwise requested by Sponsor or CRO.

How will CRM’s complimentary feasibility service benefit sponsors and CROs?
It is a service designed to assist both the Industry (Sponsors/CROs) and Investigators, and improve efficiency and timelines. CRM functions as a one stop center for national feasibility coverage via its centralized service. A centralized service would mean Sponsors and CROs only need to approach one point to have the overall outcome for Malaysia. This means they can save on resources and manpower for following-up on feasibility in Malaysia and focus them into other important operations.

CRM leverages the strengths of a government owned company to conduct feasibility studies such as:

  1. Latest knowledge on Malaysian landscape
  2. Updated database and wide pool of Investigators to select from
  3. Covers approach of all MOH, MOHE and Private hospitals
  4. Strong network and rapport with Investigators and Sites
  5. Ability to identify ground level needs of Malaysian Sites for trials
  6. From barriers noted, ability to identify improvement points for clinical trials in Malaysia
  7. And able to highlight these to high level Ministry of Health Officials to drive change from the top level

On top of all that, the service is absolutely complimentary. All the Industry needs to do is shoot us an email.

Read more contents from CRM Bulletin Issue 9. Download here!

What do you enjoy most about your job?
Meeting Investigators as well as Industry people! I’ve met many wonderful people while working here. It’s exciting to see the growth of Industry Sponsored Research in Malaysia – how more Investigators are picking up on ISR and how more Sponsors and CROs are bringing their trials to Malaysia. Also to see how CRM is driving change as an organization and improving the ISR landscape in Malaysia.
Personally, I also get a lot of satisfaction from driving a good response from Malaysia for full feasibility studies.

And the most challenging part of your job?
Meeting deadlines given by Sponsors and CRO which are much shorter than our standard timelines. We do receive requests with shorter timelines (sometimes less than 24 hours for a pre-feasibility, or 3 days for a full feasibility study) which we also assist with. However, we are unable to fully utilize our resources within so little time to achieve optimal results. It would be great if a Sponsor or CRO can include CRM near the beginning of a project, rather than nearing the end as this would help to achieve optimal results.

A Day in the Life of the Head of Finance & IT, Clinical Research Malaysia

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.

Read more contents from CRM Bulletin Issue 8. Download here!

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.