OmegaCare -Decentralized Clinical Trial Support

Enabling Protocol-Compliant Care Beyond the Site

OmegaCare provides home-based healthcare services designed to support clinical research operations, reduce site burden, and improve patient compliance. By extending study activities beyond traditional clinical settings, OmegaCare enables decentralized and hybrid trial models while maintaining protocol integrity, data quality, and regulatory alignment.

Our model focuses on standardized home visits, sample collection, patient follow-up, and data capture, all integrated into the broader Omega ecosystem.

What We Do

OmegaCare supports clinical studies through structured, protocol-aligned home healthcare services, including:

  • Home-based sample collection (blood, urine, swabs, stool, and protocol-defined samples)
  • Patient monitoring and follow-up visits
  • Vital sign measurements and structured assessments
  • Administration support for study-related procedures (as permitted by protocol)
  • Patient compliance support and visit window management
  • Source data documentation aligned with study requirements

All activities are performed by trained healthcare professionals operating under standardized workflows.

How It Works

Protocol Alignment & Visit Planning

Home visit requirements are defined according to protocol specifications, including visit windows, sample types, and required procedures.

Patient Scheduling & Coordination

Visits are scheduled in alignment with study timelines and patient availability, ensuring compliance with protocol-defined windows.

Home Visit Execution

Trained personnel perform sample collection, assessments, and documentation following SOPs and study-specific instructions.

Sample Handling & Transfer

Samples are processed, labeled, and transported under controlled conditions to the central laboratory (e.g., HelixLab) or designated facilities.

Data Capture & Integration

Data collected during visits are documented and transferred in alignment with sponsor systems (eCRF, EDC) and study workflows.

Ongoing Monitoring & Feedback Loop

Continuous coordination with study teams ensures issue tracking, deviation management, and operational optimization.

Regulatory & GCP Alignment

OmegaCare services are designed in accordance with:

  • ICH GCP (International Council for Harmonisation – Good Clinical Practice)
  • GCLP (Good Clinical Laboratory Practice) principles where applicable
  • Data integrity standards (ALCOA+)
  • Chain-of-custody and traceability requirements
  • Patient privacy and data protection regulations

All processes are documented, auditable, and aligned with sponsor and CRO expectations.

When Is OmegaCare Critical?

OmegaCare becomes particularly valuable in:

  • Decentralized or hybrid clinical trial designs
  • Studies with frequent sampling requirements
  • Longitudinal follow-up studies
  • Vulnerable or mobility-limited patient populations
  • Trials requiring strict visit window adherence
  • Studies aiming to reduce site workload and patient dropout

Services are delivered in compliance with applicable regulatory frameworks and may be performed through Omega operational units or authorized partner infrastructures, depending on study requirements. All activities are conducted in alignment with protocol specifications and applicable standards.

Visit the OmegaCare website for more detailed information on services, operational model, and patient-focused solutions.

Omega care