Post authorization safety studies (PASS) services
Utilize our standalone software, delegate specific pharmacovigilance tasks to our expert team, or opt for a comprehensive, full-service PASS solution.
When you need a PASS?
Post authorization safety study (PASS) can be required by the authorities:
– during the marketing authorization application process to get more information about the safety and efficacy of the product due to small size of the safety and efficacy data set at the time of the application
– to learn more about a specific safety related aspect of a drug
– it can be also required after the update of the risk management plan (RMP) as a method to monitor and control a risk
Let us help you!
Tepsivo offers full end-to-end service for non-interventional register based post authorization safety studies in partnership with RWD / RWE experts from RemedyBytes.
Our organization has a unique offering of modern software products, services for safety data management, and an expert team for planning and executing studies using European healthcare registries.
Software for PASS
Modern tools for efficient study management
Tepsivo Platform
Tepsivo Platform is a tool for managing the study and study data. You can use it to maintain all the PASS related information in one place or even to track several studies simultaneously. With Tepsivo Platform, you can manage study information in a validated environment with a full audit trail.
Tepsivo Safety Database
Tepsivo Safety Database is an easy to use and affordable database solution for managing the data collection and reporting of safety data for PASS. It’s a system that comes with full validation documentation and can be set up immediately as a SaaS for any kind of organization.
The price of the database does not increase with the number of users or cases and the unlimited use of Gateway, XML import and export, generating CIOMS and Medwatch documents and, perhaps most importantly for PASS, aggregate report tables for periodic safety reporting. You have full control over your own data and there are no hidden costs related to migration, analysis or updates.
Safety Services for PASS
Outsourcing of pharmacovigilance activities
Case Processing
Tepsivo offers safety data collection and reporting services for PASS. Tepsivo takes care of the collection of any potentially safety relevant data on behalf of the study Sponsor.
We translate and analyze all data using the Tepsivo Platform, enter relevant cases to Tepsivo Safety Database and report cases to the regulatory authorities following the required submission methods and timelines.
Using Tepsivo Safety Database and Tepsivo Platform, we prepare aggregate data for interim study reports and periodic safety reports.
Safety Training for Investigators
If the study involves contracted physicians outside of the Sponsor’s organization who need pharmacovigilance training, we offer both face-to-face training and interactive e-learnings using our learning management system with skill testing and certification.
PASS Processes
Tepsivo’s quality management system and processes have been designed to be compatible with almost any kind of organization allowing us to be flexible with the scope of services provided to the Sponsor.
Conducting PASS
The full end-to-end study service
If you are looking to contract the PASS to a research organization, do not hesitate to contact Tepsivo for more information. We offer end-to-end services for non-interventional register based post authorization safety studies (PASS).
This includes everything from planning, creating and executing the Study Protocol to providing a Principal Investigator and retrieving the data from healthcare registries.
Let’s have a chat
Whatever your needs are, we look forward to getting in touch with you.
Feel free to drop us a message and we will contact you right away.
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