Privacy Policy

1. Scope

This Policy applies to information processed through ablatotech.com (the “Site”), our investor and partner communications, and our clinical-research operations worldwide. Country-specific notices (e.g., GDPR Article 13/14 notices, U.S. state privacy notices, Brazilian LGPD notices) supplement and, where required, supersede this Policy.

2. Information We Collect

• Site visitors: IP address, device/browser metadata, pages viewed, referral source, and information you submit through forms (name, email, organization, message).
• Investors and partners: business contact details, accreditation status where applicable, and correspondence.
• Clinical-trial participants (only at trial sites and only with informed consent): identifiers permitted by the protocol and ICF, demographic data, medical history, study assessments, adverse-event reports, biospecimens and derived data, and pharmacogenomic data when the protocol requires it.
• Healthcare professionals & investigators: professional credentials, NPI/registration identifiers, and study-conduct data.
• Job applicants: résumé/CV data and information you choose to provide.

3. Lawful Basis for Processing (GDPR / UK GDPR)

Where the GDPR applies, we rely on: (a) consent (e.g., trial participation, marketing communications); (b) performance of a contract; (c) legal obligation (pharmacovigilance, regulatory reporting); (d) vital interests (safety reporting); and (e) legitimate interests (site security, analytics balanced against your rights). Special-category health data is processed only under Article 9 grounds — principally explicit consent, public health, or scientific research with appropriate safeguards.

4. How We Use Information

• Operate, secure, and improve the Site and our services.
• Communicate with partners, investigators, regulators, and investors.
• Conduct, monitor, and report on clinical trials in accordance with the approved protocol.
• Meet legal, regulatory, and pharmacovigilance obligations (e.g., FDA/EMA/MHRA/PMDA reporting, REMS).
• Detect, prevent, and respond to fraud, abuse, security incidents, and policy violations.

5. Clinical-Trial Data — Specific Notice

Trial participants’ data is collected and processed by investigator sites under the IRB/IEC-approved protocol and the participant’s Informed Consent Form (ICF). Ablatotech, as sponsor, receives coded (pseudonymized) data — identifiers are retained at the site. Re-identification is performed only where required for safety reporting or regulatory inspection. Trial data is retained for at least the period required by ICH E6(R3), 21 CFR 312.62, EU CTR, and other applicable laws (typically 25 years for marketing-authorized products).

6. Sharing & Disclosure

We share information with: contracted service providers (CROs, central labs, eCRF/EDC vendors, pharmacovigilance, IT and cloud infrastructure) under written agreements (BAAs where HIPAA applies; SCCs or IDTA where required for cross-border transfers); regulatory authorities (FDA, EMA, MHRA, PMDA, NMPA, ANVISA, etc.); IRBs/IECs; auditors and inspectors; current and prospective partners under confidentiality obligations; and successors in the event of a corporate transaction. We do not sell personal information.

7. International Data Transfers

Ablatotech operates globally. Where personal data is transferred outside its country of origin, we use recognized transfer mechanisms (EU/UK Standard Contractual Clauses, Swiss SCCs, the EU-U.S. Data Privacy Framework where applicable, or other lawful mechanisms). A copy of the transfer mechanism is available on request to privacy@ablatotech.com.

8. Security

We employ administrative, technical, and physical safeguards proportionate to the sensitivity of the data, including encryption in transit and at rest, role-based access control, audit logging, periodic risk assessments, vulnerability management, vendor due diligence, and incident-response procedures aligned with HIPAA Security Rule, ISO/IEC 27001, and 21 CFR Part 11 expectations.

9. Retention

We retain personal data only as long as necessary for the purposes described or as required by law. Trial-related records follow the regulatory minimum retention periods. Site analytics and marketing data are typically retained for 24 months unless a shorter period applies under local law.

10. Your Rights

Depending on where you live, you may have the right to access, correct, delete, restrict, or object to the processing of your personal data; withdraw consent; receive a portable copy of your data; or lodge a complaint with a supervisory authority (e.g., your national DPA, the UK ICO, the U.S. FTC, your state attorney general). To exercise these rights, contact privacy@ablatotech.com. Trial participants should first contact their investigator site, as the site holds the key linking coded data to your identity.

11. Children

Our Site is not directed to children under 13 (or the equivalent minimum age in your country). Pediatric clinical research is conducted only under protocols specifically approved for pediatric participation, with assent and parental/guardian consent as required by law.

12. Cookies & Analytics

The Site uses essential cookies for security and functionality, and may use limited first-party analytics to understand aggregate usage. Where required by law, we obtain consent before placing non-essential cookies. You can control cookies through your browser settings.

13. Changes

We may update this Policy to reflect changes in our practices or applicable law. The “Effective date” above will be updated. Material changes will be communicated through the Site or directly to affected individuals.

14. Contact & Data Protection Officer

Ablatotech, Inc.
Privacy Office · privacy@ablatotech.com
EU Representative (Art. 27 GDPR) and UK Representative are listed in the country-specific notices provided to participants and partners. Pharmacovigilance contact: safety@ablatotech.com.

This Policy is provided for transparency and does not create contractual rights. Country-specific notices and the trial Informed Consent Form govern in case of conflict.