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Clinical Trials

Why Do You Want to Specifically Choose Indonesia As Your Clinical Trial Destination?

As we explore the unparalleled opportunities for clinical research within Southeast Asia, Indonesia emerges as a beacon of promise, offering a host of advantages that make it a prime destination for conducting clinical trials.

Indonesia presents a cost-effective environment for clinical trials, encompassing competitive pricing for medications, treatments, investigator fees, site team expenses, as well as services provided by Contract Research Organizations (CROs), depots, and distribution channels.

Competitive Costs
01.

With a population exceeding 279 million (the largest one in Southeast Asia), Indonesia provides a fertile ground for expedited subject recruitment, ensuring swift enrollment of participants across a diverse spectrum of disease prevalence.

Highly Populated Nation
02.

Now with an improved regulatory environment, Indonesia facilitates expedited start-up procedures by allowing for parallel submission to the Ethics Committee (EC) and the local Food and Drug Administration (BPOM). The average approval timeline of just 3 - 5 months for IEC and BPOM approvals, researchers can swiftly initiate clinical trials with minimal delays.

Prompt Start-Up Procedures
03.

Indonesia provides MTA to enable sample shipment to overseas locations, fostering international collaboration and research endeavors. With a review and approval timeline of 4-5 months, researchers benefit from expedited access to vital research materials.

Material Transfer Agreement (MTA)
04.

Now with an improved regulatory environment, Indonesia facilitates expedited start-up procedures by allowing for parallel submission to the Ethics Committee (EC) and the local Food and Drug Administration (BPOM). The average approval timeline of just 3 - 5 months for IEC and BPOM approvals, researchers can swiftly initiate clinical trials with minimal delays.

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  • South East Asia, particularly Indonesia has ample resources, capabilities, and operational efficiency in executing clinical trials. As the largest country in the region, Indonesia is a powerhouse with a vast archipelago that offers a diverse genetic pool and a substantial population size. This diversity is crucial for clinical trials, providing a broad spectrum of participants and ensuring robust and comprehensive study results. Supported by numerous clinical trial centers, especially those in Indonesia, the region offers the largest population size in South East Asia. This ensures swift and effective trial execution, making Indonesia a focal point for clinical research within South East Asia.

  • South East Asia and Indonesia in particular, is a hub of esteemed Key Opinion Leaders (KOLs) who bring a wealth of expertise and experience to the clinical research arena. Indonesian KOLs are renowned for their pivotal roles in fostering collaboration and knowledge exchange, contributing significantly to the region’s healthcare advancements. Many of these leaders hold prestigious positions within international expert groups, enhancing the credibility and global relevance of clinical trial findings from South East Asia. Their involvement is evidence to Indonesia’s growing influence and commitment to shaping the future of global healthcare.

  • Clinical data generated from trials conducted in South East Asia and including Indonesia hold worldwide acceptance, endorsed by regulatory authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This recognition underscores the robustness and reliability of clinical trial outcomes from the region.

  • Conducting clinical trials in South East Asia especially in Indonesia offers substantial cost advantages compared to other regions within the Asia-Pacific (APAC) or traditional hubs in the US and Europe. The region's lower operational costs, coupled with competitive pricing for clinical trial services, present an economically viable option for sponsors aiming to optimize efficiency and cost-effectiveness in their research endeavors.

Benefits of Conducting Clinical Trial in Southeast Asia

Outsourcing clinical trials to Southeast Asia provides several compelling benefits, driving the growing interest and investment in the region's clinical research landscape, especially in Indonesia.

 

Here are some key advantages your company can leverage from conducting clinical researches in Indonesia:

Indonesia presents a cost-effective environment for clinical trials, including competitive pricing for treatments, investigator fees, site team expenses, and services provided by Contract Research Organizations (CROs), depots, and distribution channels.

Competitive Costs
01.

With a population exceeding 279 million (the largest in Southeast Asia, number 4 in the world), Indonesia has large, diverse, and treatment naive population who are suitable to participate in many clinical trials.

Highly Populated Nation
02.

The Indonesian regulatory environment has been enhanced, enabling expedited start-up procedures and regulatory timeline through parallel submission to the Ethics Committee (EC) and the Indonesian National Agency of Drug and Food Control (BPOM). With an average approval timeline of just 3-4 months for IEC and BPOM approvals, researchers can swiftly initiate clinical trials with minimal delays.

Prompt Start-Up Procedures
03.

Indonesia provides MTA to enable sample shipment to overseas locations, fostering international collaboration and research endeavors. With a review and approval timeline of 4-5 months, researchers benefit from expedited access to vital research materials.

Material Transfer Agreement (MTA)
04.

Indonesia offers the opportunity for a 0% Value Added Tax (VAT) rate if the product under study will not be marketed within the country. This favorable tax incentive further enhances the cost-effectiveness of conducting clinical trials in Indonesia.

0% Value-Added Tax (VAT)
05.

By 2025, it is estimated for Indonesia to achieve USD3.79 billion market revenue, the largest among Southeast Asian countries.

Potential Pharmaceutical Market Revenue
06.

Charting New Territory in Southeast Asia

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Southeast Asia, with its vast patient pools and cost-effective quality, is an appealing market for clinical research.

It provides diverse patient demographics with a population of more than 691 million, 40% of which is from Indonesia.

This makes it an ideal location for conducting a wide range of therapeutic area clinical trials.

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Why Indonesia and Southeast Asia?

Expedited Subject Recruitment

Currently Indonesia is the world fourth most populous country. This means there is large, diverse, and treatment naive population who are suitable to support many clinical researches in Indonesia.

Subject recruitment rate is crucial for the success and efficiency of clinical research. It is vital for:

  • Maintaining study timelines to meet regulatory deadlines and deliver timely research findings.

  • Achieving statistical power, which requires sufficient sample sizes only possible through successful recruitment.

  • Enhancing trial efficiency and minimizing costs associated with extended study durations and resource allocation.

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In this case study, we aim to demonstrate our proficiency in meeting subject recruitment targets across two distinct studies. The first study focuses on recruiting healthy subjects, while the second study involves patients.

#2: CHRONIC KIDNEY DISEASE DRUG

#1: COVID-19 VACCINE

STUDY

II

III

Phase

200

9,500

Subject

1 month

1,5 months

Recruitment Period

Chronic Kidney Disease Adult Patient

Healthy Adult

Group

3

6

Sites

Efficacy and immunogenicity of the product in hemodialysis patients with anemia associated with Chronic Kidney Disease.

Efficacy and safety of recombinant COVID-19 vaccine (Sf9 cell) in preventing virologically confirmed symptomatic COVID-19

Study Objective

Our capability to expedite subject recruitment processes signifies our operational efficiency and strategic approach to trial management. For patients, this capability is exemplified by our local expertise and collaborative efforts with sites possessing a high prevalence of relevant conditions. By leveraging our network and understanding of local healthcare landscapes, we facilitate targeted recruitment efforts, optimizing patient enrollment and trial efficiency. Similarly, for healthy subjects, our capability lies in our ability to employ innovative recruitment strategies, including community outreach programs, to attract and enroll participants from primary healthcare facilities efficiently and effectively.

Case Study

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Medical Device and Spot Medicine

Helping to develop more innovation in  medical devices and sports medicine.

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Oncology

Conducting multiple trials for cancer treatments.

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Hepatology

Focused on liver health research.

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Urology

Pioneering urological treatments for better outcomes.

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Hematology and Cardiovascular

We were involved in hypotension and anemia treatment.

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Endocrinology

Our portfolio has 10+ studies involving 1,150+ participants, to address critical endocrine disorders such as diabetes.

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Dermatology

Responding to the increasing demand in the skincare industry, we have conducted 200+ studies.

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Immunology and Tropical Diseases

Involved in several immunology studies and specialized in tropical diseases, especially in Indonesia and already involving 2,700+ participants.

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Nutritional

Advancing dietary interventions for better health in early life nutrition and adult nutrition. We have been working on 10+ nutritional studies involving 1,000+ subjects.

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Hormonal

Experienced in conducting studies with 400+ subjects, we help to advance treatments in this field.

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Vaccine

Renowned as our flagship therapeutic area, we've spearheaded over 20+ global and regional studies, involving 32,000+ participants.

Therapeutic Area

As a Contract Research Organization (CRO), our extensive expertise spans multiple therapeutic areas. Notably, we have considerable experience in the following areas: vaccine, endocrinology, hematology and cardiovascular, dermatology, and nutritional.

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Project Management

Managing every aspect of your clinical trial, from planning and budgeting to execution and closeout.

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Post-Study Support

Providing post-study support services, including publication support, and other requirements to help you achieve your post-trial objectives.

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Clinical Data Management and Statistical Analysis

Performing comprehensive data management services, including data collection, cleaning, and analysis, to ensure the integrity and quality of your clinical data.

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Site and Patient-Centric Solutions

Equilab provides solutions to enhance site performance and patient engagement throughout the clinical trial process.

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Recruitment & Retention Strategies

We design and implement customized recruitment and retention strategies to ensure timely enrollment and retention of study participants.

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Pharmacovigilance

Monitoring the safety of investigational products and ensuring compliance with adverse event reporting requirements through our pharmacovigilance team.

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Regulatory Affairs

Navigating the complex regulatory landscape in Indonesia to ensure compliance with global regulations and guidelines.

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Medical Writing

Equilab’s experienced medical writers draft clear, concise, and compliant documents to support all stages of your clinical study process.

Our Services

Having more than 20 years in conducting clinical research in Indonesia, Equilab provides an extensive array of end-to-end services tailored to meet all clinical trial requirements. From meticulous study preparation to seamless final report and manuscript submission for publication, we ensure a comprehensive approach at every stage of your clinical trial journey.

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