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W-30: How a Centralized Feasibility Service Attracts Sponsors and Contract Research Organizations to Malaysia





Poster Presenter

      Khairul Faizi Khalid

      • Head of Business Development
      • Clinical Research Malaysia
        Malaysia

Objectives

A single point of contact for sponsors and contract research organizations (CROs) is vital in streamlining and accelerating feasibility studies in a particular country. This poster describes how a centralized feasibility service attracts sponsors and CROs to Malaysia.

Method

Records on the number of feasibility studies and companies who have utilized Clinical Research Malaysia’s centralized feasibility service were obtained and a simple analysis was done to determine the growth of companies who have engaged this service from 2014 – 2016.

Results

There was a total of 68 companies/organizations (37 sponsors and 31 CROs) who utilized CRM’s centralized feasibility service in 2016 compared to only 16 companies in 2014. This translates into a 325% growth in companies who have engaged CRM with their feasibility assessments within the three years. Of these companies, 85% (n=58) are international organizations and the rest being local CROs and sponsors. The amount of full feasibilities received in 2014 also increased from 59 to 98 feasibility studies in 2016. Full feasibility is accompanied by submission of complete documentation for individual site outreach by the sponsor/CRO and this includes a confidential disclosure agreement, protocol synopsis and site assessment questionnaire. In 2015 and 2016, 225 and 202 pre-feasibility assessments were recorded in CRM respectively. Pre-feasibility is defined as information that is collected for preliminary, higher level assessments which allows sponsors and CROs to make decisions at a national and global level.

Conclusion

Our data indicate that a centralized feasibility management has garnered increased interest of sponsors and contract research organizations (CROs) in Malaysia, an indication of the various benefits it can offer to companies intending to conduct clinical trials in Malaysia. Prior to having a centralized feasibility management service in Malaysia, sponsors and CROs were conducting feasibility assessments individually. This exclusive approach means that they rely on their own internal databases to conduct feasibility assessments. Individual company databases are based on each company’s experiences with previous feasibility approaches. Due to the dynamic nature of Malaysia’s research ecosystem, the data built on previous experiences have led to outdated data which has misguided and delayed feasibility approaches. The Ministry of Health, Malaysia through Clinical Research Malaysia (CRM), established a centralized feasibility service to support sponsors and CROs. This service which is offered complimentary to these companies, capitalizes on a comprehensive updated internal database of investigators, and enables outreach to a wider range of investigators and sites. This centralized process leads to centralized knowledge of the research environment which benefits CROs and sponsors engaging the service. Functioning as a single point of contact, standardized processes leads to streamlined communications which reduces delay and confusion on the ground. This means a shorter turnaround time than if a sponsor or CRO were to approach individually. The positive growth of sponsors/CROs is made possible through a centralized feasibility team coordinating and overseeing communications with sites. Thus, on a nationwide perspective, a centrally managed feasibility structure is an attractive alternative to sponsors and CROs looking to enhance efficiency and width of a feasibility outreach, avoid redundant processes and promote a more accurate assessment of Malaysia’s capabilities.