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Ronal Simanjuntak, Commercial ManagerIndonesia-headquartered Equilab International, one of Southeast Asia’s first WHO-accredited independent CROs, is actively bridging this gap through its widely accredited CRO services. Its clinical studies are accepted by regulators in the UK, Netherlands, Poland, Spain, Hungary, and Germany. The firm is certified by the Medicines and Healthcare products Regulatory Agency (MHRA), National Pharmaceutical Regulatory Agency (NPRA) Malaysia (the first CRO recognized by them), The Indonesian Food and Drug Authority (BPOM), and SNI ISO/IEC 17025. Equilab International also has multiple SNI ISO/IEC 15189-certified facilities with unmatched capabilities that enable better and faster drug development for its clients. The firm’s core services revolve around clinical trial management, dermatology testing, contract analysis, central lab, pharmacokinetics services, and bioavailability/bioequivalence assessments.
Equilab International’s Indonesian facility comprises 75 beds and an on-site clinical laboratory. State-of-the-art hematology and blood chemistry analyzers power its clinical prowess. Equilab International supports the analytical side of drug development with more than 250 analytical validated methods and through a wide range of analytical assay equipment, including dedicated instruments for pharmacokinetics and bioavailability studies, LCMS/MS, HPLC-UV/FL spectrophotometry (UV-VIS), and dissolution testing.
From a technical standpoint, Equilab International employs advanced software for complex clinical trials and research studies, including WinNonLin for statistical analysis and the NuGenesis software system to support data integrity.
“We are the largest CRO for clinical trial, central lab, pharmacokinetics and bioavailability studies in South East Asia, leveraging our clinical and analytical strengths to run impactful studies that strengthen clinical trial projects for global pharma organizations with faster timelines and high quality standards. During the pandemic, we successfully managed eight global clinical trials for COVID-19 vaccines with a large number of participants (up to 9,500/study), which shows our expertise as a global clinical trial company capable of managing large studies,” says Ronal Simanjuntak, Commercial Manager of Equilab International.
A key example of Equilab International’s varied client projects is a vaccine study it conducted during the COVID-19 pandemic. Equilab International managed this project and satisfied the international sponsor’s desire to run their trial in Indonesia due to its larger and varied population. This is just one instance of Equilab International’s part in the success of numerous global trials and multi-country drug development projects.
The company plans to expand its services to additional markets by registering in Portugal, Jordan, Zimbabwe, and Tanzania. Through this expansion, Equilab International wants to improve its position in the EU and Africa’s CRO and biologics domains.
Company
Equilab International
Management
Ronal Simanjuntak, Commercial Manager
Description
Equilab International is one of the first independent clinical research organizations (CROs) based out of Indonesia that is also the first WHO-accredited CRO in South East Asia. The firm provides services such as clinical trials, dermatology testing, contract analysis, central lab, pharmacokinetics services, and bioavailability/bioequivalence with faster timeline and high quality standard.
Equilab International, a leading provider of bioequivalence studies in South East Asia, underwent an inspection by WHO. The publication of the public inspection report (PIR) followed a comprehensive evaluation by WHO, which included an assessment of the bioequivalence study report for an injection product manufactured by one of their esteemed customers—an Indonesian pharmaceutical pioneer specializing in reproductive health.
The PIR serves as evidence of Equilab's compliance with WHO's good clinical practice and good laboratory practice standards during the bioequivalence study. This compliance is substantiated through an examination of the facilities, interactions with personnel, and a review of relevant documents by WHO.
Since the onset of the pandemic in March 2020, the scheduling of the WHO inspection was repeatedly postponed due to the uncertainties surrounding travel restrictions. In February 2021, in light of these challenges, WHO decided to conduct a remote inspection, necessitating meticulous preparation and coordination to ensure seamless online interactions despite the time zone difference between Indonesia and Switzerland.
Dr. Elham Kassary and Ms. Stephanie Croft, the official inspectors, led the five-day online inspection process. Despite the demanding nature of the interactions while inspecting Equilab's facilities, procedures, and documentation, their review encompassed various aspects, including the company's history, clinical study performance, informed consent procedures, ethics committee approvals, investigational medicinal product (IMP) accountability, dispensing and storage, processing and handling of collected biological samples, equipment qualification and maintenance, employee training, computer controls, and a facility tour.
Equilab International expressed gratitude for the significant support received from the Badan Pengawas Obat dan Makanan Republik Indonesia in preparing for this important milestone. With this achievement, Equilab International officially becomes the first CRO in ASEAN to successfully complete the WHO Prequalification program inspection. As a global participant, Equilab International is eager to contribute to the field, committed to delivering high-quality bioequivalence studies and clinical trials.