Last Updated: January 14, 2026

1. Introduction and Scope

Alchemy Trials (“the Company,” “we,” “us,” or “our”) operates as a professional clinical research management entity and a nationally operating Site Management Organization (SMO). We are committed to protecting the privacy and security of the information we collect from our partner medical sites, healthcare professionals, and study participants. This policy outlines our practices regarding data collection, use, and disclosure in accordance with federal and state laws.

2. HIPAA Compliance and PHI

As an SMO, Alchemy Trials acts as a Business Associate to healthcare providers under the Health Insurance Portability and Accountability Act (HIPAA).

• We strictly adhere to HIPAA regulations to safeguard Protected Health Information (PHI).
• We implement administrative, physical, and technical safeguards to ensure the confidentiality and integrity of all electronic PHI (ePHI).
• All research personnel deployed to partner sites are trained in HIPAA compliance and protocol-specific privacy requirements.

3. Information Collection

We collect information necessary to facilitate, supervise, and oversee clinical studies. This includes:

• Provider Information: Professional credentials, NPI numbers, and contact details of Medical Directors and clinic staff.
• Participant Data: Demographics, medical history, and diagnostic results as required by specific study protocols.
• Operational Data: Site performance metrics and recruitment volume data.

4. Use of Information

Data collected is used exclusively for the following purposes:

• Study Execution: Managing patient recruitment and enrollment management.
• Regulatory Compliance: Maintaining meticulous monitoring and documentation for federal and sponsor audits.
• Reporting: Providing accurate research findings to study sponsors and Contract Research Organizations (CROs).

5. Data Disclosure and Sharing

Alchemy Trials does not sell personal or clinical data. We share information only with:

• Study Sponsors: Such as Roche, Meridian Bioscience, and other diagnostic developers for the purpose of clinical validation.
• Regulatory Authorities: Including the FDA or state health departments when required by law.
• Legal Requirements: If necessary to protect our legal rights or comply with a judicial proceeding.