Privacy Policy

ObjectivoData is committed to providing you with the best possible service while protecting your privacy. ObjectivoData is bound by the Privacy Act 1988 (Cth), which sets out principles concerning the privacy of individuals.

Collection of Personal Information

For registration and access to clinical trial services, you are required to submit personally identifiable information including:

  • Name and email address
  • Contact details (phone, mobile)
  • Clinical trial data as required by the study protocol
  • Other sensitive health information relevant to the trial

How We Store Your Data

Your data is stored using Google Cloud infrastructure:

  • Database Location: Sydney, Australia (Google Cloud SQL)
  • Authentication: Firebase Authentication (global infrastructure with Australian data residency)
  • Encryption: Data encrypted in transit (TLS/SSL) and at rest (AES-256)
  • Compliance: SOC 2 Type II and GDPR compliant infrastructure

Use of Personal Information

We collect and log user activity data (including user ID, timestamp, actions performed, and IP address) solely for regulatory compliance purposes as required by 21 CFR Part 11. This audit trail data is used exclusively for:

  • Maintaining complete audit trails of all clinical trial data modifications
  • Ensuring compliance with FDA 21 CFR Part 11 requirements
  • Supporting regulatory inspections and audits
  • Investigating data integrity issues when required

We do not use this data for marketing, analytics, or any purpose outside regulatory compliance and data integrity protection.

Sharing of Personal Information

We may share personal information with:

  • The clinical trial sponsor and authorised research personnel
  • Third-party service providers (Google Cloud, Firebase) bound by strict confidentiality agreements
  • Regulatory authorities as required by law

We will never sell your personal data to third parties.

Legal Bases for Processing

We process your personal information lawfully, fairly and transparently. We collect and use your information where:

  • It's necessary for performance of the clinical trial contract
  • It satisfies a legitimate interest (research, legal rights protection)
  • You give explicit consent for trial participation
  • We need to comply with legal or regulatory obligations

Data Security

We protect your information using commercially acceptable means including encryption, access controls, and regular security audits. However, no method of electronic transmission is 100% secure. If you are uncomfortable with this inherent risk, you should not participate in trials using this platform.

Your Rights and Controlling Your Information

Choice and consent: By providing information, you consent to its collection, use, and disclosure per this policy. Users under 16 must have parental/guardian consent.

Access and portability: You may request details of personal information we hold. We will provide this in CSV or machine-readable format where possible.

Correction: Contact us if information is inaccurate, outdated, or misleading. We will take reasonable steps to correct it.

Restrict or erase: You may request we restrict processing or erase your data, subject to legal and regulatory retention requirements for clinical trials.

Complaints: Contact us with any data protection concerns. You also have the right to contact regulatory authorities.

Data Retention

Clinical trial data must be retained according to regulatory requirements (typically 15-25 years post-trial). Personal account data may be deleted upon request, subject to these regulatory obligations.

Data Breach Notification

We will comply with applicable data breach notification laws and inform affected individuals without undue delay if a breach occurs.

International Transfers

While primary data is stored in Sydney, Australia, some services (Firebase Authentication, Google Cloud infrastructure) may process data internationally. All transfers comply with GDPR and Australian Privacy Principles.

Changes to This Policy

We may update this policy to reflect current practices. Continued use after changes constitutes acceptance of the updated policy.

Contact Us

For questions about this privacy policy: info@objectivodata.com

Last updated: January 2025

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