The Challenge: Genomic data is massive, unstructured, and often siloed from the clinical EHR, making longitudinal tracking nearly impossible.

Key Services:

• • Biomarker Mapping: Integrating NGS (Next-Generation Sequencing) results directly into clinical workflows.

  • Longitudinal Patient Tracking: Building frameworks to track oncology patients from initial diagnosis through multiple lines of therapy.

  • Variant Curation: Professional assistance in categorizing genomic variants for research-readiness.

The Deliverable: A unified Genomic Data Roadmap that aligns your clinical lab results with patient consent and research goals.

The Challenge: Pharma companies spend 60% of their time cleaning data rather than analyzing it. Most data lacks the “provenance” (origin) required for regulatory submission.

Key Services:

• • RWE Asset Generation: Curating Real-World Evidence (RWE) sets that meet FDA/EMA standards for external control arms.

  • Therapeutic Efficacy Analytics: Evaluating how specific patient cohorts respond to therapies using permissioned, de-identified data.

  • Site Feasibility Studies: Using Consent Vault technology to map where specific patient populations exist before you launch a drug trial.

The Deliverable: A Certified Research-Ready Data Set, complete with a full audit trail for regulatory filing.

The Challenge: 80% of clinical trials fail to meet enrollment timelines, often because patient “willingness” isn’t captured at the point of care.

Key Services:

• • Automated Matching Architectures: Setting up systems that flag eligible patients based on genomic markers and clinical history.

  • Patient Engagement Journeys: Designing digital consent experiences that educate patients on the benefits of trial participation.

  • Multi-Site Harmonization: Ensuring that data collected across 50 different trial sites is standardized and legally compliant.

The Deliverable: A Trial Recruitment Optimization Plan that increases enrollment rates while reducing administrative paperwork burden on staff.

The Challenge: In a post-GDPR/HIPAA world, a single data leak in a drug trial can result in $10M+ in fines and the loss of a decade of research.

Key Services:

• • SOC 2 Type II Readiness: We consult with your IT teams to mirror our SOC 2 controls, ensuring your internal data handling is “Vault-grade.”

  • Consent Lineage Audits: Providing a Chain of Custody report that proves every byte of data used in your study was ethically sourced.

  • Global Privacy Harmonization: Strategy for handling data across borders (US, EU, UK) where privacy laws conflict.

The Deliverable: A Compliance Trust Report that can be shared with stakeholders, partners, and regulators to prove institutional integrity.