Pharmacovigilance & Safety Reporting

One of the many challenges in clinical trials for both compounds and medical devices in development is the need to rapidly communicate any potential safety concerns or findings during pharmacovigilance to all applicable regulatory authorities, investigators, and ethics committees - in many cases within 7 days or less. With many clinical trials now being conducted across multiple countries and languages, the safety reporting process has become that much more complex.

Trial Interactive's data room technology can help alleviate the time and language burdens associated with safety reporting by allowing clinical development teams around the globe to rapidly translate and share pharmacovigilance information - such as suspected unexpected serious adverse reactions (SUSARs), serious adverse events (SAEs), hospitalization reports, and discharge summaries - in a centralized collaborative workspace. With the ability to quickly and securely collect, track, translate, and share safety data from investigative sites with internal and external stakeholders, the safety reporting process is significantly accelerated.

Trial Interactive offers a variety of customizable features, including:

• In-house Translation - As the world's leading provider of language and business services to the life sciences industry, TransPerfect can provide immediate, high-quality translations of safety data, as well as automatic workflow notifications when the translations are complete.
• Workflow - Sponsors will receive automatic notification when an investigative site submits SUSARs, SAEs, or related supporting documentation to Trial Interactive for translation. All source documents are maintained and organized according to sponsor preferences (by study, site, etc.). Trial Interactive also provides detailed tracking information to keep sponsors up-to-date on the status of each translation project.
• Risk Management - Trial Interactive provides extensive 21 CFR Part 11 audit trail metrics and activity tracking for both the investigator and users, including the date and time each document was opened, pages viewed, the total time spent viewing individual pages or full documents, and whether the document was printed and/or saved. These metrics protect sponsors and CROs by providing evidence that investigators have been made aware of all SUSARs and SAEs and that those investigators have made all efforts to promptly notify their ethics committees of the events.
• Security - All data is hosted in an SAS 70 Level II compliant facility, encrypted, and employs multiple layers of security controls, including optional click-through, user-definable confidentiality agreements, and user and group security modification functions, ensuring that each stakeholder only sees the information that is relevant to them.
• 24/7 Support - Each client receives a dedicated customer support representative to provide consistent, end-to-end assistance for each project. Your representative is available 24 hours per day, 7 days per week to answer questions or submit projects for translation.

Please Contact Us to learn more about how Trial Interactive can streamline your global pharmacovigilance and safety reporting processes and reduce your regulatory reporting risks.