Solutions

Accelerating Development from Feasibility to Approval

Our leadership team brings extensive experience in planning and executing large-scale clinical trials for leading global pharmaceutical companies. Combining our deep expertise in clinical development and our proprietary, AI-enabled digital solutions, we offer tailored, end-to-end support to advance your therapeutic assets and medical innovations from early-stage clinical validation to eventual regulatory approval.

Creating Value Through Pharma Experience and Advanced Digital Solutions

Regulatory Strategy

We help you navigate complex global regulatory landscape for novel medical device, SaMD and pharmaceutical products, ensuring full alignment with FDA and EMA expectations.

  • Regulatory strategy
  • FDA Pre-Submission support
  • Dossier preparation and submission

Study Design

By aligning study objectives with regulatory expectations and leveraging our in-house digital tools, we help you generate reliable, high-quality protocol for clinical validation studies.

  • Protocol design
  • Statistical analysis plan
  • Case report form (CRF) development

Study Feasibility

By leveraging our AI-enabled RecruitNavigator, we empower smarter and faster trial planning. This approach minimizes trial and enhances the overall enrollment speed of your clinical studies.

  • Global site and PI identification
  • Patient enrollment and budget forecasting
  • Competing study analysis

Data Management

Our data management solutions combine advanced electronic data capture system (ATOM EDC) with AI-assisted data quality checks.

  • CDISC-compliant database setup
  • AI-powered data review and discrepancy detection
  • Data cleaning and reconciliation

Ready to move your trial forward?

Partner with us to accelerate your path from concept to regulatory approval

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Advanced Trial Operation Management System (ATOM)

An award-winning, GCP and 21 CFR Part 11 compliant Electronic Data Capture (EDC) system—designed for reliability, security, and operational efficiency. The industry’s only fully integrated, all-in-one data management platform.

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