Multi-disciplinary approach to identify, assess and minimize the risks
Clinical safety management is a complex and critical process during the clinical development phase. Balancing the potential benefits with the risks, accurate and timely reporting, maintaining high-quality data, and complying with evolving regulatory guidelines are challenging.
We have experienced professionals, including pharmacovigilance experts, regulatory experts, statisticians, etc. who are well-versed in safety regulations and best practices, working cross-functionally and with the big picture in mind.
We help you ensure the safety of patients and establish the safety profile of the drug in a controlled setting and support its regulatory approval.
What we offer:
- Safety Protocol Development: Develop safety protocols, including the creation of safety monitoring plans and risk management plans.
- Adverse Event Monitoring: Monitor adverse events throughout the duration of clinical trials, and collect, assess, and report safety data in compliance with regulatory requirements.
- Safety Database Management: Maintain and manage safety databases to store and organize safety-related information, ensuring data accuracy and accessibility.
- Safety Signal Detection: Detect potential safety signals, helping sponsors identify emerging safety concerns.
- Safety Reporting: Prepare and submit safety reports to regulatory authorities, including expedited safety reports for serious adverse events, in accordance with regulatory timelines.
- Safety Data Analysis: Analyze safety data to provide insights into the safety profile of the investigational drug, helping sponsors make informed decisions.
- Regulatory Compliance: Ensure that safety-related activities and reporting comply with local and international regulatory requirements, reducing the risk of regulatory issues.
Why work with us?