Clinical Technology Consulting
Precision Guidance for eCOA & Clinical Technology Programs
Howry Solutions guides biopharma and healthcare organizations through the complexity of eCOA, mHealth, wearable, and BYOD programs — from protocol design through regulatory submission and audit readiness.
What We Do
End-to-End Clinical Technology Expertise
From early protocol design to post-deployment compliance, Howry Solutions provides hands-on expertise across the full lifecycle of clinical technology programs.
eCOA & mHealth Strategy
Vendor selection, platform evaluation, and implementation oversight for electronic clinical outcome assessments, mobile health applications, wearables, and BYOD programs.
Protocol Review & Design
Hands-on review of study protocols and data collection strategies to ensure eCOA and clinical technology requirements are clearly defined, feasible, and aligned with regulatory expectations.
Regulatory Alignment
Guidance on FDA, EMA, GCP, and 21 CFR Part 11 compliance for electronic data capture and clinical technology systems — from validation planning through inspection readiness.
Project Management
Senior-level oversight of eCOA and clinical technology workstreams, coordinating across sponsors, CROs, and vendors to keep programs on schedule and within scope.
Why Howry Solutions
Senior Expertise. Independent Perspective.
Independent & Focused
As an independent consultant, Howry Solutions works across multiple concurrent engagements without the overhead of a large firm — delivering senior-level attention and accountability on every project.
Regulatory Depth
Deep familiarity with FDA, EMA, GCP, and 21 CFR Part 11 requirements as they apply to eCOA and clinical technology — built through years of hands-on regulatory engagement.
Biopharma & Healthcare Focus
Exclusively focused on biopharma and healthcare clients, with experience spanning early-phase studies through late-stage trials and commercial programs.
Regulatory Focus
Built for Compliance from Day One
Regulatory compliance in eCOA and clinical technology is not a checkbox — it is an ongoing discipline. Howry Solutions advises clients on building programs that satisfy regulatory expectations from the ground up, reducing risk and preparing teams for inspections before they happen.
Discuss Your ProgramU.S. Food & Drug Administration
Guidance on FDA expectations for electronic data capture, patient-reported outcomes, and clinical technology validation.
European Medicines Agency
Alignment with EMA guidelines for eCOA and digital health technologies in clinical trials conducted in the EU.
Good Clinical Practice
Ensuring clinical technology programs meet ICH E6 GCP standards for data integrity, audit trails, and subject safety.
Electronic Records & Signatures
Validation and compliance support for electronic records and signatures under 21 CFR Part 11 requirements.
Get in Touch
Let's Talk About Your Program
Whether you're navigating a new eCOA program, preparing for a regulatory inspection, or evaluating clinical technology vendors, Howry Solutions is ready to help. Reach out to start a conversation.
Austin, TX
Serving clients across the U.S. and globally.