Security & Compliance
Updated: 2025-08-03
Your data security, confidentiality, and regulatory compliance is our highest priority — and we structure our biostatistical consulting services accordingly.
Data Security
BSC® employs enterprise-grade security measures and privacy controls to safeguard your sensitive information throughout every phase of our statistical consulting engagement. Our comprehensive security framework ensures your data remains protected, confidential, and compliant with applicable regulations.
Information Security
Biomedical Statistical Consulting LLC takes a security-by-design approach to protecting sensitive client data. Our team continuously invests in robust security measures so you can trust our services.
Infrastructure Security
Our data handling infrastructure is designed with multiple layers of protection to ensure your client data remains secure during transmission, storage, and analysis. Protections include end-to-end encryption, least privilege access controls, secure statistical computing environments, and adherence to industry best practices for data management.
Operational Security
Our information security protocols continuously monitor and protect against unauthorized access across all computing systems, networks, and data repositories. We maintain strict access controls and audit trails for all client data handling activities.
Statistical Analysis Security
BSC® provides robust data protection and administrative controls throughout the project lifecycle. We implement secure data transfer protocols, encrypted environments, and comprehensive documentation. Our computing infrastructure supports HIPAA-compliant workflows and maintains detailed audit logs for regulatory compliance.
Privacy & Confidentiality
BSC® maintains a comprehensive privacy compliance program and is committed to partnering with clients on privacy and regulatory compliance efforts. Our privacy framework addresses the unique requirements of our services.
How We Handle Your Data
Our team is dedicated to developing and implementing data privacy processes and safeguards that meet or exceed industry standards and regulatory requirements. We conduct ongoing training to ensure we remain current with developments in data protection legislation and essential privacy practices for statistical research. Every BSC® team member signs comprehensive confidentiality agreements to maintain the security and privacy of data.
Client Agreements
BSC maintains up-to-date agreements that comply with the latest and applicable regulations and industry standards, including HIPAA, GCP, and international privacy frameworks. Our documentation describes our data privacy processes, security standards, and compliance in detail.
Data Governance
Data governance encompasses the policies and procedures that dictate how client data is acquired, processed, and utilized throughout its lifecycle — from collection and processing to reporting, archival, and secure deletion. BSC®'s commitment to rigorous data governance ensures that your research data remains secure, confidential, accurate, and accessible according to regulatory requirements.
Regulatory Policies
BSC® maintains transparent and comprehensive policies appropriate for the regulatory environment(s) in which we operate. These policies detail how rights can be exercised regarding compliance with applicable regulations, including HIPAA, FDA guidelines, and international privacy standards.
GDPR & Global Privacy Standards
The General Data Protection Regulation (GDPR) and other global privacy regulations govern the collection and use of personal data. As these represent the most stringent global privacy standards, we have aligned our privacy program with applicable GDPR requirements and other applicable international privacy regulations for statistical research.
Regulatory Compliance
BSC® maintains a comprehensive security and privacy program designed to protect data in accordance with various regulatory and industry standards. Our compliance framework is aligned with industry best practice.
FDA & GCP Compliance
Good Clinical Practice (GCP) Standards BSC adheres to FDA Good Clinical Practice guidelines and International Council for Harmonisation (ICH). Our procedures ensure data integrity, traceability, and regulatory compliance throughout the project lifecycle.
HIPAA Compliance
Health Insurance Portability and Accountability Act BSC is fully compliant with HIPAA requirements for protecting and confidentially handling Protected Health Information (PHI). Our business associate agreements, security controls, and data handling procedures meet all HIPAA Privacy and Security Rule requirements.
21 CFR Part 11 Compliance
Electronic Records and Electronic Signatures Our statistical computing systems and data management procedures comply with applicable FDA 21 CFR Part 11 requirements for electronic records and electronic signatures in clinical research and pharmaceutical development.
Service Reliability & Business Continuity
BSC® is trusted by pharmaceutical companies, biotech firms, and research institutions worldwide. Our robust business continuity planning and redundant systems ensure reliable statistical support throughout your critical research projects.
Enterprise-Grade Infrastructure
We partner with leading cloud security providers that maintain compliant data centers built with world-class computing architecture, ensuring maximum business resilience for mission-critical research.
High Availability & Disaster Recovery
BSC® runs on infrastructure designed to protect your data through multiple geographic zones for redundancy, comprehensive backup programs, and regularly tested disaster recovery procedures. We maintain detailed business continuity plans to ensure uninterrupted service to support critical project phases.