Safety

CEC/Adjudication Module

Safety reporting is needed to properly manage your clinical trial. Good safety reporting should be conducted immediately following an adverse event. The necessary reports and data needs to be provided to required IRBs and FDA/EU in the correct, regulated format. The inability to quickly, properly record and alert institutes of safety issues and events can deteriorate data quality and jeopardize your study.

TrialPoint is designed to quickly adapt to any adverse event. When an adverse event occurs TrialPoint supplies the documentation you need to handle the event properly and compliant. TrialPoint’s triggered events provide the instructions, data/document requirements, and actions needed to smoothly navigate the unexpected or problematic event. The Databean team in addition to the intuitive capabilities of TrialPoint software will provide the full support you need for safety monitoring.

TrialPoint’s CEC/Adjudication Module meets your risk and safety management requirements. Our system helps to identify, analyze, and mitigate risks. The adjudication process helps to ensure safety and efficacy for an array of situations. Studies with complex adjudication endpoints, enrollment concerns, cultural or global concerns, and therapeutic expertise concerns require special review. TrialPoint’s system helps handle these situations, identify and manage the risks, and continue to ensure safety across sites, devices, and patients. Databean’s global network and expertise provide the additional CEC/Adjudication support you need. Our TrialPoint software and expertise will help you to navigate these situations. By identifying studies that will face these situations and will require a strong focus on CEC/Adjudication preparation, we can strategically plan a risk and safety management plan.

Benefits:

• Adverse events and situations run smoothly
• Global quality data