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.