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Mitosis Bioscience: Serious Adverse Events (SAEs) and Adverse Events (AEs) Reporting

At Mitosis Bioscience, we prioritize the safety and well-being of all individuals involved in product. As part of our unwavering commitment to excellence and responsibility, we have implemented rigorous protocols for reporting and addressing Serious Adverse Events (SAEs) and Adverse Events (AEs).

Why SAE and AE Reporting Matters

Serious Adverse Events and Adverse Events play a critical role in:

• Ensuring Patient Safety: Monitoring and addressing potential risks promptly.

• Maintaining Regulatory Compliance: Adhering to global standards and ethical guidelines.

Our Reporting Process

1. Comprehensive Monitoring

• Continuous observation of clinical trials and post-market activities.

• Use of advanced tools to track and analyze events in real time.

2. Immediate Reporting

• Dedicated channels for reporting SAEs and AEs.

• Timely communication with regulatory authorities and stakeholders.

3. Thorough Investigation

• Detailed analysis of each reported event.

• Collaboration with medical experts to assess and mitigate risks.

4. Transparent Communication

• Clear updates to participants, healthcare providers, and regulators.

• Proactive steps to maintain trust and uphold ethical standards.

What Are SAEs and AEs?

• Serious Adverse Events (SAEs): Events that result in significant outcomes, such as hospitalization, disability, or life-threatening conditions.

• Adverse Events (AEs): Any undesired effects experienced during a clinical study or after using a product, regardless of severity.

How to Report an Event

If you are aware of an SAE or AE, we encourage you to report it through our streamlined process:

1. Contact Us Directly:

• Phone: (855) 11 600 044

• Email: side-effect@mitosisbioscience.com

2. Use Our Online Reporting System:

• [Under Developed]

3. Follow the Submission Guidelines:

• Provide detailed information about the event.

• Include relevant medical records or supporting documents if available.

Our Commitment

Mitosis Bioscience takes SAEs and AEs seriously because:

• Lives Depend on It: Every report contributes to safer outcomes for patients.

• Innovation Demands Responsibility: A robust reporting system fuels continuous improvement and ethical progress.

Partner With Us for Safer Science

Join Mitosis Bioscience in ensuring the highest standards of safety and integrity. Together, we can make a difference in advancing bioscience while protecting those who matter most.

Contact Us Today For more information about SAE and AE reporting.