Cencora PharmaLex is pleased to announce the general availability of psiXchange 3.0: the latest release of our software designed specifically to make complex clinical trial safety reporting more efficient and accurate, while reducing cost and effort.
Built and supported by our global team of pharmacovigilance and technology experts, psiXchange 3.0 provides intelligent process automation and configurable workflows combined with embedded, continuously updated regulatory intelligence.
For busy safety and clinical teams at biopharmaceutical companies and contract research organizations (CROs) struggling with complex reporting requirements and limited resources, psiXchange 3.0 offers:
- Automation of the end-to-end distribution, tracking, and acknowledgement receipt process for business-critical clinical trial safety documents to Sites, Ethics Committees, Competent Authorities, Notified Bodies, and Institutional Review Boards for any defined country
- The embedded psiQ “brain,” a comprehensive PV regulatory intelligence database actively updated by our global team of experienced PV experts and configurable with your own regulatory intelligence – making up-to-date clinical trial safety reporting expertise available at your fingertips for 55 countries, with more being added on a regular basis
- A user-friendly smart portal, supporting day-to-day business for recipients and enabling the viewing, downloading, and acknowledging of safety reports and overview of relevant safety information per study and site in real time – letting teams proactively manage receipt acknowledgements and oversee distribution from a central “source of truth”
- A library of Investigator Brochures and relevant safety information for the trials being conducted, replacing the need for complex and cumbersome GAP packs – increasing patient safety by making it faster and easier for study teams to understand patient risk and focus more attention on patient care
- Support for third-party submissions (required by some Ethics Committees and Competent Authorities) by automatically preparing everything required for the submission package, including current intelligence around submission instructions and the ability to track submissions and acknowledgements against timelines and priorities – helping to mitigate the added time, effort, and compliance risk involved in these submissions
- Flexible delivery and pricing options, including enterprise and site-based software licenses and expert professional services, to help support the specific business requirements of small, mid-sized and large biopharmaceutical companies and CROs
The result? Greater confidence that the right clinical trial safety document is getting to the right recipients in the right format at the right time – freeing your busy safety and clinical teams to focus on other critical tasks.
For more information, please visit www.pharmalex.com/psixchange
