At Althian Clinical Research S.A. de C.V., headquartered at Modesto Arreola 2856, Deportivo Obispado, 64040 Monterrey, N.L., we understand that confidentiality, integrity, and security of information are essential in the clinical research sector.

With over 17 years of experience as a boutique CRO in Mexico and Latin America, we provide our clients and partners with this Privacy Notice in compliance with the Mexican Federal Law on Protection of Personal Data Held by Private Parties, as well as applicable regulations across Latin America, the United States, and the European Union, ensuring certainty and trust in every project.

1. Data Controller

Althian is responsible for the collection, processing, and safeguarding of the personal and corporate data you provide. We implement administrative, technical, and physical controls that comply with the highest international standards (ICH-GCP, GDPR, HIPAA, ISO 27001).

2. Personal Data Collected

In the course of providing our clinical research services, we may collect and process:

• Identification and contact information of legal representatives, project leads, and investigators.
• Professional, academic, and employment data.
• Tax and financial data for contractual and billing purposes.
• Technical and regulatory information related to protocols, clinical studies, and submissions.

Althian does not request sensitive personal data from client representatives unless strictly required for regulatory or contractual purposes.

3. Purpose of Data Processing

The personal data collected will be used for the following purposes:

• Commercial and contractual relationship management with sponsors, pharmaceutical, biotechnology, and medical device companies, and research organizations.
• Design, conduct, management, and monitoring of clinical trials in Mexico and Latin America.
• Regulatory compliance with national and international authorities (COFEPRIS, ANMAT, INVIMA, FDA, EMA, among others).
• Pharmacovigilance and drug safety.
• Administrative management, billing, and tax compliance.
• Corporate communication regarding project progress, technical and regulatory reporting.

Additionally, and only when authorized, we may use your data to:

• Share information on new services and collaboration opportunities.
• Send invitations to scientific forums, congresses, and webinars organized by Althian.

4. Data Transfers

Althian may share data with third parties only under the following circumstances:

• National and international regulatory authorities, to comply with applicable requirements.
• Ethics committees in research.
• Sponsors, strategic allies, and research partners, with whom we maintain confidentiality agreements and strict compliance frameworks.

In all cases, data transfers are carried out under the highest standards of security, confidentiality, and international compliance.

5. Data Subject Rights

Representatives of clients and partners may exercise their Access, Rectification, Cancellation, and Opposition (ARCO) rights at any time by submitting a request to our Privacy Officer at: [insert email].

6. Data Retention

Data will be retained only for the time necessary to fulfill the purposes outlined in this Privacy Notice and in accordance with applicable legal requirements in Mexico, Latin America, and other jurisdictions where Althian operates or collaborates.

7. Information Security

At Althian, we implement world-class information security protocols, including:

• Encryption of sensitive data.
• Secure servers with restricted access.
• Periodic compliance audits.
• Ongoing privacy and data protection training.

8. Updates

This Privacy Notice may be updated at any time. Updates will be published on our website [www.althian.com] and communicated through the contact details provided by our clients.

9. Althian’s Commitment

At Althian, we know that the success of every clinical trial depends not only on scientific excellence but also on the trust placed in the management of sensitive information.

Our expertise as a boutique CRO in Mexico and Latin America enables us to deliver agile, tailored solutions fully compliant with international regulations, ensuring that every project benefits from:

• Regulatory reliability in complex LATAM environments.
• Operational agility with specialized local teams.
• Global alignment with FDA, EMA, and international standards.
• Absolute confidentiality throughout all stages of research.

With Althian, your data is protected, and your projects move forward with the support of a team committed to science, ethics, and innovation.