Introduction

Biomedical Statistical Consulting LLC ("BSC," "we," "us," or "our") is committed to protecting the privacy of our clients and website visitors. This Privacy Policy describes how we collect, use, and safeguard your business contact information.

1. Who We Are

Biomedical Statistical Consulting LLC provides clinical trial design and statistical analysis services to medical device companies.

• Location: 2400 Market St Suite 200, Philadelphia, PA 19103

• Privacy Contact: privacy@biomedstat.com

2. Scope: Clinical Trial Data vs. Business Data

This policy applies solely to business contact information and technical data collected through our website.

Note on Clinical Data: Data related to clinical trial subjects is handled under separate, project-specific agreements (such as Data Use Agreements or Business Associate Agreements) that comply with FDA regulations, ICH-GCP guidelines, and HIPAA, where applicable.

3. Information We Collect and Why

We collect basic information necessary to conduct business and respond to inquiries:

• Contact Information: Name, job title, company name, work email, phone number, and address.

• Usage Data: IP address, browser type, and website activity (collected via essential cookies to ensure our website functions correctly).

Legal Basis: We process this data to fulfill our consulting contracts with you or to respond to your business inquiries based on our legitimate interest.

4. How We Use and Share Information

We use your information to provide our services, maintain business records, and communicate with you about our services.

• No Sale of Data: We do not sell, rent, or trade your personal information.

• Service Providers: We use secure third-party services for essential business operations. For details about our service providers and their security practices, please visit our Trust Center at trust.biomedstat.com

• Legal Requirements: We may disclose information if required by law or to protect our legal rights.

5. International Data Transfers

BSC is headquartered in the United States. If you are contacting us from outside the U.S., please be aware that your information will be transferred to and processed in the United States. We use standard contractual protections and security measures to ensure your data is treated securely and in accordance with this policy.

6. Data Retention

We retain your business contact information for as long as necessary to provide our services and to comply with our legal and professional obligations. For most project-related information, we maintain certain records for at least 7 years to align with tax and regulatory standards. Data may be retained for longer periods where required for the defense of legal claims or as otherwise permitted by law.

7. Your Rights

Depending on your jurisdiction (such as the EU/UK or California), you may have the following rights regarding your data:

• The right to access, correct, or delete your personal information.

• The right to object to or restrict certain processing.

• The right to data portability.

To exercise any of these rights, please contact us at privacy@biomedstat.com. We will respond to your request within 30 days.

8. Security and Compliance

We implement industry-standard security measures, including encryption, access controls, regular security assessments, and audit logging to protect your data from unauthorized access, loss, or misuse.

BSC maintains security practices aligned with SOC 2 Type II standards and undergoes regular third-party security audits.

8.1 Incident Response

In the event of a data breach that affects your personal information, we will:

• Notify affected parties promptly upon discovery

• Provide details about the nature of the breach and the data involved

• Outline the steps we are taking to mitigate harm and prevent future incidents

• Comply with all applicable data breach notification laws

9. Children’s Privacy

Our services are directed to business professionals and are not intended for individuals under the age of 16. We do not knowingly collect information from children.

10. Contact Us

If you have questions about this Privacy Policy, please contact us:

Biomedical Statistical Consulting LLC

2400 Market St Suite 200, Philadelphia, PA 19103

Email: privacy@biomedstat.com

Phone: +12158391501