Decentralised & Hybrid Clinical Trials
Enabling patient-centric trial designs through remote and hybrid approaches that bring the study to the participant. MTK combines proven operational frameworks with integrated digital health technologies to reduce patient burden, broaden geographic reach, and accelerate enrolment — all while maintaining the rigorous data quality and regulatory compliance your programme demands.
Reimagining Trial Delivery Around the Patient
Traditional site-based models place significant demands on participants — travel time, rigid visit schedules, and geographic limitations that restrict who can take part. MTK's decentralised and hybrid trial solutions remove these barriers by combining remote data capture, virtual assessments, and local healthcare services to create a seamless participant experience without compromising scientific integrity.
Whether you are running a fully virtual study or augmenting existing site operations with remote touchpoints, our team designs bespoke DCT strategies tailored to your protocol, patient population, and regulatory landscape. Every element — from eConsent through direct-to-patient logistics — is orchestrated through MTK's integrated technology platform for end-to-end visibility and control.
End-to-End DCT Services
Six integrated capability areas that together deliver a complete decentralised or hybrid trial programme — from remote monitoring and virtual consent through home-based nursing and direct drug supply.
Remote Patient Monitoring
Continuous and scheduled capture of vital signs, wearable sensor data, and connected device readings that flow directly into the clinical database for real-time safety oversight.
- Wearable and sensor integration
- Real-time safety alerting
- Automated data reconciliation
- Compliance dashboards
eConsent & ePRO Integration
Digital informed consent with multimedia education materials and integrated electronic patient-reported outcomes that capture the patient voice wherever they are located.
- Multimedia consent modules
- Remote re-consent workflows
- Validated ePRO instruments
- Multi-language support
Telemedicine Visits
Secure, regulatory-compliant virtual visit capabilities that enable investigator–participant interactions for assessments, adverse event follow-up, and protocol-defined evaluations.
- HIPAA & GDPR-compliant video
- Integrated visit scheduling
- Source documentation capture
- Investigator assessment forms
Home Health Nursing
Qualified mobile nursing networks that bring protocol-required procedures — blood draws, vital signs, ECGs, and IP administration — directly to the participant's location.
- GCP-trained nursing network
- Sample collection & shipping
- Protocol procedure execution
- Real-time visit reporting
Direct-to-Patient Drug Shipment
Temperature-controlled investigational product logistics that deliver study medication to participants with full chain-of-custody tracking and regulatory-compliant accountability.
- Cold-chain management
- Track-and-trace visibility
- Accountability reconciliation
- Return & destruction workflows
Hybrid Site Models
Flexible trial architectures that blend traditional site visits with remote activities, optimising the visit schedule to balance scientific requirements with participant convenience.
- Visit-level flexibility design
- Site & remote activity mapping
- Protocol deviation risk controls
- Operational playbook development
Platform Modules Powering Your DCT
MTK's integrated eClinical platform provides the digital backbone for decentralised trial operations. Each module is purpose-built for clinical research and connects seamlessly to deliver a unified data layer across all remote and site-based activities.
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EDC — Electronic Data Capture
Cloud-based eCRF access from any location with real-time edit checks, automated query management, and offline data entry for areas with limited connectivity.
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eConsent — Digital Informed Consent
Remote consent workflows with multimedia content, knowledge checks, and legally compliant electronic signatures that meet 21 CFR Part 11 and EU eIDAS requirements.
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ePRO — Electronic Patient-Reported Outcomes
Validated instrument delivery via smartphone and tablet with configurable reminder schedules, compliance tracking, and direct integration to the clinical database.
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rSDV — Remote Source Data Verification
Risk-based remote monitoring capabilities that allow CRAs to perform source verification, query resolution, and oversight activities without requiring on-site travel.
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CTMS — Clinical Trial Management
Centralised tracking of site and remote activities, visit milestones, nursing deployments, and IP shipments within a single operational dashboard.
Why Choose MTK for Decentralised Trials
Executing a decentralised or hybrid trial requires more than technology alone. It demands operational expertise, regulatory knowledge, and a platform that unifies every moving part. Here is what sets MTK apart.
Patient Reach
Expand recruitment beyond traditional site catchment areas by meeting participants where they are, improving diversity and accelerating enrolment timelines across geographies and demographics.
Technology Platform
A unified eClinical suite — EDC, eConsent, ePRO, rSDV, and CTMS — connects every remote and site-based activity through a single data layer, eliminating fragmented point solutions.
Regulatory Compliance
DCT strategies aligned with FDA, EMA, and MHRA guidance on decentralised elements, ensuring every remote activity meets GCP standards, data integrity requirements, and participant safety obligations.
Operational Flexibility
Modular DCT components that can be activated or adjusted at any stage of the trial — scale remote elements up during enrolment surges or transition to hybrid models as the protocol evolves.
Launch Your DCT Programme
Ready to bring your clinical trial closer to the patient? Connect with our decentralised trials team to explore how MTK's integrated technology platform and operational expertise can transform your study design, broaden participant access, and accelerate your development timeline.