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Compliance

Compliance is a cornerstone of our operations. We operate with integrity, accountability, and transparency. Our comprehensive compliance program is designed to meet or exceed all industry standards, including federal, state, and international regulations governing clinical research, patient care, and data management. 

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Education in an integral part of who we are.

Commitment to Ethical Standards and Regulatory Excellence

We hold ourselves to the highest standards of integrity, accountability, and transparency in all aspects of clinical research and wound care delivery. Our commitment to ethical conduct and regulatory compliance is more than a policy—it is a guiding principle that shapes our decisions, actions, and culture.
 
We rigorously adhere to all applicable federal, state, and international regulations, including FDA, HIPAA, and GCP guidelines, ensuring that our clinical protocols, data management, and patient interactions meet and exceed industry benchmarks. Our dedication safeguards the rights, safety, and privacy of every patient while reinforcing public trust in the research we conduct and the treatments we provide.
 
Each member of our team is not only trained in ethical and regulatory standards but is also empowered to advocate for best practices, raise concerns, and drive continuous improvement. Through proactive audits, staff education, and open dialogue, we foster an environment of shared responsibility and ethical vigilance.
 
By integrating ethical excellence with operational precision, we support innovations that are both scientifically valid and ethically sound. Our work does not merely comply—it exemplifies what ethical healthcare and research should look like. 

Our commitment is your peace of mind

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Speak Up: Reporting Compliance Concerns

SerenaGroup encourages an open environment where compliance concerns can be raised without fear of retaliation. We have established confidential channels for employees, partners, and participants to report any suspected violations of our compliance standards. All reports are taken seriously and investigated promptly to ensure that our commitment to ethical conduct is upheld.

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Partnering with Confidence

When you partner with SerenaGroup, you can trust that our commitment to compliance is unwavering. We are dedicated to conducting our research with the highest level of integrity, ensuring that every step of our process meets the rigorous standards expected of a leader in wound care clinical research.

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Contact Us

For questions or more information about our compliance policies, please contact our compliance team.

compliancedepartment@serenagroups.com

833-674-6125

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Commitment to Quality Care

Our comprehensive Quality Program integrates patient feedback, evidence-based best practices, and continuous improvement strategies to ensure exceptional care. Standard Operating Procedures (SOPs) are meticulously developed and annually reviewed in collaboration with our Medical Director, aligning with the latest clinical research and industry standards.

We emphasize excellence in specialized areas including:

  • Clinical Research: Driving innovation through ongoing studies and data analysis.
  • Hyperbaric Oxygen Therapy (HBOT): Delivering advanced treatment protocols for optimal healing.
  • Wound Care Management: Utilizing cutting-edge techniques and best practices to promote recovery and patient comfort.

Patient surveys also play a vital role in shaping our services, helping us refine care delivery and uphold the highest standards across all programs.

Key Compliance Areas