A team of physicians, nurses, and pharmacists
Throughout the life cycle of the program, Product Safety ensures timelines are met in global safety reporting in clinical trials, supports and educates site staff, and provides a safety profile through management and analysis of the safety data as part of their pharmacovigilance services. Our experienced, highly trained safety team is composed of physicians, registered nurses, clinical pharmacists, and medical technologists. These safety and surveillance experts specialize in the collection, evaluation, and submission of safety data in clinical trials. The cornerstone of all of the Product Safety services is the concise and rapid exchange of safety information among all parties.
Our product safety and pharmacovigilance services for clinical trials include:
- Clinical and marketed product serious adverse event (SAE) management: Our experienced staff members provide global safety processing and reporting services from database development to event reporting with full documentation of the system validation and process implementation
- Marketed product adverse event (AE) data intake: We provide the processing and reporting of initial and follow-up adverse event reports from consumers, health care providers, and sales representatives
- Case processing: Our seasoned personnel provide secure, accurate, and timely case entry and evaluation into a client safety system or into Rho’s validated safety database
- Safety document development: Our trained and experienced safety team will work with the client to provide customized forms based on Rho templates or client forms that are consistent with safety systems and reporting requirements
- SAE reporting: Expert personnel provide global expedited reports including MedWatch, Council for International Organizations of Medical Sciences I (CIOMS I), the Vaccine Adverse Event Reporting System (VAERS), and periodic reports for submission to regulatory agencies
- SAE listings production: Rho Product Safety works with the Regulatory team to provide safety information for regulatory documents including annual reports, periodic safety update reports (PSURs), and ad hoc reports
- Coding: We provide consistent and accurate coding of medical terms and products using the Medical Dictionary for Regulatory Activities (MedDRA) and WHO Drug Dictionary (Uppsala Monitoring Centre)
- Event narrative: We deliver narratives for both post-marketing AEs and all SAEs that provide a chronology of the reported event, are medically reviewed, and are updated with the most current reported information
Our product safety team also provides:
- Analysis and medical review
- Scientific literature surveillance
- Safety signal detection
- Product complaint management
- E2B safety data exchange
Product Safety in clinical trials provides accurate and complete safety information to ensure better protection
A core team of seasoned case-entry and assessment specialists is assigned to each protocol. Working under the direction of the lead project safety scientist, our team processes lab and diagnostic results, medical histories, and concomitant medications to support the validity of every reported event.
At Rho, product safety is about ensuring better protection of patients by providing information that is clear, accurate, and accessible. It’s about knowing that the data we manage can improve treatments and keep patients safe.
A comprehensive solution for pharmacovigilance
Oracle® Argus Safety is an advanced and comprehensive pharmacovigilance software system. An off-the-shelf, web-based software package, Argus provides the collection, tracking, reporting, and analyzing of adverse events and serious adverse events for drugs, biologics/vaccines, and devices in accordance with global regulatory requirements. It ensures the integrity and confidentiality of safety data used in support of regulatory submissions.
Argus provides a robust library of reports and the flexibility to create ad-hoc reports to meet sponsor and project needs for safety data analysis. The ease of database configuration allows for quick start-up and ongoing addition of studies, products, and sites. Argus Safety and Rho Product Safety provide a centralized, global safety solution for the life cycle of a product from early clinical development through post marketing.