LyfeSci Research & Innovation

1. Acceptance of Terms

By accessing and using the LyfeSci Research & Innovation website, services, or entering into any agreement with us, you acknowledge that you have read, understood, and agree to be bound by these Terms of Service and our Privacy Policy. These terms apply to all users, clients, research sites, investigators, and other parties engaging with our clinical research services.

Important: If you do not agree with any part of these terms, please do not use our services or website.

2. Clinical Research Services

LyfeSci provides comprehensive clinical research and development services in compliance with applicable regulations. Our services include:

Core Services

Pre-clinical consulting and development
Early clinical development (Phase I)
Late-phase development (Phase II-III)
Post-marketing surveillance and RWE
Patient recruitment and retention
Regulatory affairs and submissions

Specialized Capabilities

Clinical data management
Biostatistics and data analysis
Medical writing and documentation
Pharmacovigilance and safety monitoring
Quality assurance and compliance
Decentralized and hybrid trials

3. Regulatory Compliance Framework

FDA Compliance

All clinical research activities are conducted in strict adherence to FDA regulations including:

21 CFR Part 11 (Electronic Records)
21 CFR Part 50 (Informed Consent)
21 CFR Part 56 (IRB Regulations)
21 CFR Part 312 (IND Regulations)

21 CFR Part 314 (NDA Regulations)
FDA Guidance Documents
ICH-GCP Guidelines
FDA Inspection Readiness

Additional Regulatory Standards

International Council for Harmonisation (ICH) Guidelines
European Medicines Agency (EMA) requirements where applicable
Health Insurance Portability and Accountability Act (HIPAA)
State and local regulatory requirements
International regulatory standards for global studies

4. Professional Service Agreements

Clinical research services are provided under separate written agreements that specify:

Scope of Work

Detailed description of services, deliverables, timelines, and performance standards

Regulatory Responsibilities

Clear delineation of regulatory obligations, reporting requirements, and compliance responsibilities

Data Management

Data handling procedures, security measures, and ownership rights

Quality Assurance

Quality standards, monitoring procedures, and corrective action protocols

5. Data Integrity and Security

ALCOA+ Principles

All data generated and managed by LyfeSci adheres to ALCOA+ principles:

Attributable

Legible

Contemporaneous

Original

Data Security Measures

End-to-end encryption for data transmission and storage
Role-based access controls and user authentication
Regular security audits and vulnerability assessments
Backup and disaster recovery procedures
Incident response and breach notification protocols

6. Intellectual Property Rights

Intellectual property rights are clearly defined in individual service agreements. Generally:

Client IP: Clients retain ownership of their proprietary compounds, formulations, and pre-existing intellectual property
Study Data: Clinical trial data ownership is specified in the clinical trial agreement
LyfeSci IP: We retain rights to our methodologies, processes, and know-how
Joint IP: Any jointly developed intellectual property is governed by specific agreement terms
Third-Party IP: All parties respect third-party intellectual property rights

7. Confidentiality and Non-Disclosure

Confidentiality Obligations

LyfeSci maintains strict confidentiality regarding:

Proprietary client information and trade secrets
Clinical trial protocols and study designs
Patient data and protected health information
Regulatory submissions and communications
Commercial and business sensitive information
Competitive intelligence and market data

8. Quality Management System

LyfeSci operates under a comprehensive Quality Management System that includes:

Quality Assurance

Standard Operating Procedures (SOPs)
Quality control checkpoints
Regular internal audits
Corrective and Preventive Actions (CAPA)

Compliance Monitoring

Regulatory compliance tracking
Risk management procedures
Performance metrics and KPIs
Continuous improvement processes

9. Liability and Insurance

Professional Liability

LyfeSci maintains appropriate professional liability insurance and limits liability as follows:

Professional indemnity insurance for clinical research services
Errors and omissions coverage for professional activities
Cyber liability insurance for data security incidents
General liability coverage for business operations

Specific liability terms, limitations, and indemnification provisions are detailed in individual service agreements and may vary based on the nature and scope of services provided.

10. Regulatory Inspections and Audits

LyfeSci commits to full cooperation with regulatory authorities and sponsors regarding:

FDA inspections and regulatory audits
Sponsor audits and quality reviews
Third-party audits and certifications
Document production and record access
Corrective action implementation

11. Termination and Data Handling

Upon termination of services:

Data Transfer

All client data and study materials will be transferred according to agreed procedures

Record Retention

Essential documents retained per regulatory requirements and contractual obligations

Confidentiality

Ongoing confidentiality obligations remain in effect post-termination

12. Governing Law and Dispute Resolution

Jurisdiction

These Terms of Service are governed by the laws of the State of Illinois, United States, without regard to conflict of law provisions. Any disputes will be subject to the exclusive jurisdiction of the courts in Cook County, Illinois.

Alternative Dispute Resolution

We encourage resolution of disputes through good faith negotiation and, where appropriate, mediation or arbitration as specified in individual service agreements.

13. Modifications and Updates

We reserve the right to modify these Terms of Service to reflect:

Changes in regulatory requirements or guidance
Updates to our services or capabilities
Legal or compliance developments
Industry best practices and standards

Material changes will be communicated with appropriate notice as required by law and existing agreements.

14. Contact Information

For questions about these Terms of Service, regulatory compliance, or our clinical research services:

Legal and Regulatory Affairs

LyfeSci Research & Innovation

250 Parkway Drive, Ste. 150

Lincolnshire, IL 60069

These Terms of Service reflect our commitment to conducting clinical research with the highest standards of quality, integrity, and regulatory compliance.