iNGENu
https://www.ingenucro.com/

While DCTs are gaining significant traction in the USA and parts of the EU, no Contract Research Organization (CRO) has successfully scaled decentralised clinical trials across the Asia-Pacific region—until now.

iNGENu is the first Asia-Pacific CRO to deliver FDA-focused decentralised clinical trials (DCTs) compliant with 21 CFR 312.120 while leveraging the distinct regulatory and legislative frameworks of Australia, Malaysia, Singapore, and India. By aligning DCT-permitted elements—such as eConsent, eRecruitment, telehealth, and remote monitoring—to each country's specific capabilities, iNGENu ensures speed to trial startup, cost efficiency, and data compliance for FDA submissions.

Key Elements of Decentralised Clinical Trials (DCTs)

DCTs integrate innovative tools and methodologies that enhance efficiency, patient engagement, and data quality while ensuring regulatory compliance. Key elements include:

  • eConsent: Digitally enabled platforms for secure, compliant patient consent processes.
  • eRecruitment and eScreening: Digital tools and analytics to identify, assess, and onboard participants.
  • Telehealth Consultations: Remote clinical interactions that minimise patient travel and increase accessibility.
  • Wearable Devices and Digital Biomarkers: Continuous data capture for safety and efficacy monitoring.
  • ePRO, eCOA, and eDiaries: Digital tools for remotely capturing patient-reported outcomes and adherence data.
  • Home Health Visits: Localised services for sample collection, drug administration, and patient monitoring.
  • Direct-to-Patient Logistics: Delivery of investigational products and materials directly to participants.
  • Centralised Data Platforms: Real-time tracking and integration for faster decision-making and regulatory reporting.

Leveraging Country-Specific DCT Frameworks in the Asia-Pacific

Australia: Rapid Approvals and Integrated DCT Infrastructure

Australia offers a well-established regulatory environment and legislative support for DCTs:

  • Streamlined Ethics Approval: The Human Research Ethics Committee (HREC) process facilitates approvals within 4–6 weeks, enabling rapid trial initiation.
  • Permitted DCT Elements: Legislation supports eConsent, telehealth, wearable data collection, and remote monitoring.
  • R&D Tax Incentives: Sponsors benefit from a 43.5% rebate on eligible clinical trial costs, enhancing cost efficiency.

Key Strengths:Australia's mature regulatory framework supports early-phase and complex DCT methodologies, ensuring high-quality, FDA-compliant data.

Malaysia and Singapore: Diverse Populations and Regulatory Efficiency

Malaysia and Singapore combine regulatory agility with access to diverse patient populations:

  • Regulatory Efficiency: Both countries offer fast-track approval pathways (6–8 weeks), supporting rapid trial startup.
  • Permitted DCT Elements: Legislation supports eConsent, eRecruitment, telehealth, and home health visits, ensuring seamless decentralised operations.
  • Cost-Effective and Flexible: Malaysia offers lower operational costs, while Singapore's advanced healthcare infrastructure ensures smooth implementation of DCT methodologies.

Key Strengths:These countries are ideal for studies requiring diverse participant demographics or family-focused engagement strategies.

India: Scale and Cost Advantage

India's vast treatment-naïve patient population and cost benefits make it a key location for multinational DCTs:

  • Regulatory Landscape: India's framework permits eConsent, eRecruitment, telehealth, and remote monitoring, aligning with FDA and GCP standards.
  • Permitted DCT Elements: Home health visits, wearable devices, and eScreening support decentralised data collection and monitoring.
  • Cost Efficiency: India offers significantly reduced operational costs compared to Western markets, making it an attractive destination for cost-conscious sponsors.

Key Strengths:India's scale, combined with its evolving DCT-ready framework, ensures access to a large patient population at a fraction of the cost.

Ensuring FDA Compliance Across APAC

To meet 21 CFR 312.120 requirements, iNGENu ensures all trial processes are designed to generate FDA-compliant data:

  • Scientifically Valid Data: Trials are designed to meet rigorous data quality standards equivalent to U.S. requirements.
  • Regulatory Alignment: eConsent, telehealth, and remote monitoring are implemented in line with FDA and local GCP regulations.
  • Inspection-Ready Documentation: Comprehensive records are maintained to ensure FDA inspection readiness.

iNGENu's Multinational DCT Workflow

1. Tailored Recruitment Strategies:

  • Social media campaigns and partnerships with patient advocacy groups for region-specific eRecruitment.
  • eScreening tools ensure accurate and efficient eligibility assessments.

2. Patient-Centric Data Collection:

  • Wearable devices, ePRO tools, and telehealth consultations for real-time, remote data capture.
  • Home health visits for sample collection and medication administration, ensuring convenience.

3. Integrated Data Platforms:

  • Centralised systems for real-time data monitoring and seamless FDA-compliant reporting.

4. Regulatory Oversight:

  • Strict adherence to FDA and local regulatory frameworks for all DCT elements.

Real-Life Success: Multinational APAC DCT

A pivotal Phase 2b/3 pediatric inherited metabolic rare disease study was conducted across Australia, Malaysia, and Singapore.

  • Design: Leveraged each country's DCT-permitted elements to maximise efficiency.
  • Execution: eConsent, telehealth consultations, and home health visits ensured patient engagement and supported regulatory compliance.
  • Data Collection: Wearable devices and centralised platforms provided real-time data for FDA submissions.

Conclusion: Asia-Pacific's Unique DCT Advantage

iNGENu CRO is the first to unlock the full potential of FDA-compliant decentralised trials in Asia-Pacific. By aligning DCT methodologies with the unique regulatory frameworks of Australia, Malaysia, Singapore, and India, iNGENu delivers:

  • Faster trial startup and completion.
  • Access to diverse patient pools.
  • Substantial cost savings and operational flexibility.

With its region-specific expertise and commitment to FDA compliance, iNGENu sets the gold standard for modern, multinational, decentralised clinical trials.