Tris Pharma: Putting Patients First Through Responsible Practices
At Tris Pharma, building trust is essential. We’re dedicated to the highest ethical standards and strong compliance practices in everything we do. This commitment ensures the safety and effectiveness of our products, protects patient data responsibly, and fosters strong partnerships with healthcare professionals and the communities we serve.
Building a Culture of Compliance
A strong culture of compliance is essential to ensure we operate ethically and responsibly. Our comprehensive compliance program governs all aspects of our operations, fostering a culture of integrity and adherence to the highest standards. Here’s how our program ensures we put patients first:
- Ensure Product Safety and Efficacy: We adhere to strict FDA regulations throughout the development, manufacturing and marketing of our products. This commitment guarantees that our medications meet the highest quality standards and deliver the intended therapeutic benefits.
- Protect Patient Privacy: We take data privacy very seriously. We comply with all applicable laws and regulations, such as HIPAA, to safeguard the confidentiality and security of patient information entrusted to us.
- Maintain Ethical Interactions With Healthcare Professionals: Our interactions with healthcare professionals are guided by industry codes and our internal policies. This ensures that our communications are transparent, objective and focused on providing accurate information about our products.
- Promote Responsible Financial Practices: We uphold the highest ethical standards in all financial transactions. We have clear policies and procedures in place to prevent fraud, bribery and other financial misconduct.
Compliance Framework
Based On The Seven Key Elements of Compliance
Policies and ProceduresBuilding a stronger foundation of clear and efficient policies for smoother workflow and better compliance
Tris’ commitment to clear and concise policies and procedures goes beyond compliance. These guidelines serve as the foundation for our work environment, ensuring consistent practices throughout the company. They enable employees to make informed decisions in their daily tasks, fostering a safe and compliant work environment for all. We believe readily available policies are essential for promoting accountability and ethical conduct within our organization. Regular review and updates ensure our guidelines reflect best practices and evolving regulations, contributing to a strong company culture and smooth operations.
Training and EducationInvesting in your knowledge with enhanced training opportunities
Investing in ongoing training and awareness programs is a foundation of our commitment to compliance. These programs provide employees with the knowledge and skills they need to navigate complex regulations and make ethical decisions. Our training programs offer a flexible approach, ranging from interactive online, live and virtual workshops, ensuring everyone can learn effectively. We encourage ongoing learning so our employees can actively contribute to our strong ethics and following the rules.
Monitoring and AuditingEnsuring ethical excellence with auditing and risk assessments
Proactive monitoring and auditing are crucial measures within our compliance program. This ongoing process involves regularly evaluating our adherence to established policies and procedures. We proactively identify areas for improvement by data analysis, self-assessments and targeted reviews to identify potential areas of risk or non-compliance. By proactively addressing any issues, we can minimize errors, ensure continuous improvement and demonstrate our commitment to upholding the highest ethical standards. This monitoring and auditing system fosters a culture of accountability and transparency, building trust with all our stakeholders.
Communication and PartnershipEngaging in open and collaborative partnerships
Collaboration is at the heart of our compliance approach. We prioritize clear and open communication. We hold regular discussions with employees, partners and customers to ensure everyone understands compliance expectations. This open dialogue allows us to address concerns quickly, identify potential risks together and share in our achievements. By working as a team, we leverage the diverse perspectives of our stakeholders, building a stronger compliance program.
Enforcement and ImprovementCultivating a culture of continuous compliance, together
At our core, we believe compliance isn’t just about following rules, it’s about fostering a culture of continuous improvement. While we have clear processes to address any intentional violations, our main goal is to prevent them through proactive efforts. We utilize data and feedback from monitoring and auditing to identify areas for improvement and implement corrective actions. This continuous improvement process allows us to identify areas for enhancement, refine our procedures and continuously strengthen our commitment to compliance. We believe in open communication and collaboration throughout this process, working together with our employees to cultivate a culture of accountability and ethical behavior. This collaborative approach ensures adherence to regulations and fosters shared responsibility for maintaining a strong compliance program.
Compliance and OversightProviding a clear and objective view of program activities
Effective oversight is crucial for ensuring the ongoing success of our compliance program. This function is led by a dedicated Compliance Committee and Compliance Officer, who are responsible for monitoring and reviewing program activities, investigating potential compliance issues and recommending improvements. Regular audits and assessments ensure the program’s effectiveness and help us identify areas for further enhancement. Through this oversight process, we maintain a strong culture of integrity and accountability within Tris Pharma.
Transparency in Action:
Transparency is a cornerstone of our commitment to compliance. We believe that operating openly and ethically builds trust with healthcare professionals, patients and the communities we serve. To demonstrate this commitment, we adhere to all applicable laws and regulations, ensuring the highest ethical standards, including:
- Anti-Kickback Statute (AKS): This law prohibits offering or receiving remuneration to influence the referral of healthcare services or products.
- False Claims Act (FCA): This law prohibits submitting false or misleading claims to government healthcare programs like Medicare and Medicaid.
- Food and Drug Administration (FDA) Good Manufacturing Practice (GMP) Regulations: These regulations ensure the quality, safety and efficacy of our products.
- Data Privacy Laws: We comply with regulations like HIPAA and FTC health privacy rules to safeguard patient information.
- Industry Codes: We follow ethical guidelines such as the PhRMA Code on Interactions with Healthcare Professionals.
Declaration of Compliance for California
At Tris, we are committed to the highest ethical standards in our interactions with healthcare professionals throughout California. This commitment extends to adhering to all applicable laws and regulations, including the California Health and Safety Code Sections 119400-119402 (California Compliance Law).
To ensure ongoing compliance, we’ve established a Comprehensive Compliance Program (CCP). This program reflects our commitment to ethical conduct and upholds the standards outlined in the California Compliance Law.
As of January 2024, we are in compliance with both our CCP and the California Compliance Law. We are committed to maintaining this level of compliance through ongoing monitoring and review processes. This declaration will be updated annually.
Report a Compliance Issue: Your Voice Matters!
We encourage you to report any suspected violations of our policies or the law. You can report a compliance issue anonymously using one of the following methods:
- Ethics and Compliance Helpline: This hotline offers completely anonymous reporting. Call 844-956-3287 or report online via trispharma.ethicspoint.com.
- Supervisor or Manager: Concerns can be discussed directly with a supervisor.
- Human Resources Department: The HR department is available to receive reports and answer questions.
- Compliance Officer: Reports can be submitted directly to the Compliance Officer via email at legal@trispharma.com.
- Report ALL TRIS product complaints (PQC) or adverse drug experiences (ADE) ASAP, within 1 business day.
- Call (732-940-0358) or email:
- ProductComplaints@trispharma.com (PQC)
- DrugSafety@trispharma.com (ADE)
- Call (732-940-0358) or email: