Services

Decentralised Clinical Trials

Discover iNGENū CRO's comprehensive decentralised clinical trial (DCT) capabilities — patient-centric solutions that enhance diversity, reduce costs, and accelerate trial timelines with cutting-edge technology and global reach.

Key benefits

Our decentralised approach streamlines the patient experience and reduces costs for sponsors — minimising the need for physical site visits and infrastructure while maintaining high standards of data quality and regulatory compliance.

With wider geographic reach and the ability to engage patients directly in their homes, our DCTs accelerate patient recruitment, helping to meet or exceed enrollment targets faster than traditional trial models.

By reducing patient burden and offering more flexible participation options, our DCTs significantly improve patient retention, so trials complete successfully with fewer dropouts.

Decentralised trials broaden access to diverse patient populations by overcoming geographical and linguistic barriers, making study results more generalisable and reflective of real-world diversity.

Our decentralised trial capabilities

A comprehensive suite designed to meet the needs of sponsors and patients alike — delivering trials that are more accessible, efficient, and diverse.

eScreening

Electronic screening quickly and accurately assesses patients for eligibility without physical site visits, speeding up recruitment.

eConsent

A streamlined, digital consent process compliant with all regulatory requirements, so patients can provide informed consent remotely with ease.

eRecruitment

Advanced digital recruitment leverages data analytics and targeted outreach to identify and engage participants efficiently.

Direct-to-patient IP delivery

Investigational products shipped directly to patients' homes, reducing site visits and ensuring timely access to treatments.

Telehealth consultations

Remote consultations with trial investigators, so patients receive medical guidance and support without leaving home.

Wearables for at-home data

Wearables and digital tools continuously monitor and collect vital-signs data in real time for a comprehensive picture of patient health.

ePRO, eCOA, eClinRO technology

Electronic patient-, clinical- and clinician-reported outcome technologies enable real-time data capture and analysis.

Central rating & independent adjudication

Efficacy endpoint data is centrally routed and reviewed by independent experts, maintaining integrity and reliability.

Remote, centralised monitoring

Continuous oversight of trial activities ensures compliance and data accuracy while minimising on-site visits.

Continuous real-time data

State-of-the-art digital platforms provide sponsors with high-quality, continuous, real-time data to make informed decisions.

Frequently asked questions

Decentralised clinical trials — FAQs

What is a decentralised clinical trial (DCT)?

A decentralised clinical trial moves elements of the study out of traditional sites and to the participant — using eConsent, eScreening, direct-to-patient investigational-product delivery, telehealth visits, wearables and remote monitoring. This reduces the need for physical site visits while maintaining data quality and regulatory compliance.

How do decentralised trials reduce cost?

By minimising physical site visits and infrastructure, DCTs lower per-patient and operational costs. Wider geographic reach also accelerates recruitment and improves retention, so trials complete faster with fewer dropouts.

Are decentralised trials accepted by regulators like the FDA?

Yes. iNGENū runs DCTs under ICH-GCP with 21 CFR Part 11-compliant electronic systems and centralised, independently adjudicated endpoint data, so the resulting data package supports FDA and other major regulatory submissions.

What technology does iNGENū use for decentralised trials?

A fully integrated eClinical suite: eConsent, eScreening, eRecruitment, ePRO/eCOA/eClinRO, wearables for at-home vital-signs capture, telehealth, and remote centralised monitoring with real-time data.

Ready to discuss your clinical trial?

Talk to our team about how iNGENū CRO can accelerate your research.

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