Introducing psiXchange 3.0

Automated clinical trial safety reporting software

psiXchange 3.0 automatically distributes the right clinical trial safety document to the right recipients in the right format at the right time – dramatically increasing speed and accuracy, while reducing effort and compliance risk.

psiXchange 3.0 is software built specifically for global safety reporting, offering intelligent process automation and configurable workflows combined with embedded, continuously updated regulatory intelligence.

Improve reporting accuracy and consistency

Reduce time, manual effort and cost

Enhance oversight and regulatory compliance

psiXchange gains

Built by experienced industry professionals for use by safety and clinical teams, psiXchange delivers a measurable impact on reporting efficiency.

up to 90%

reduction in time-per-submission & resource demand via automation*

up to 80%

reduction in operational costs*

up to 95%

site responsiveness rates achieved (system data)

up to 90%

reduction in resource demand*

* customer-reported outcomes; actual results may vary
§ system data for multinational biopharmaceutical company – site responsiveness improved from 41.2% to 75.2% within 12 months and to 95.2% within 24 months

Request a demo today to discover how psiXchange 3.0 could help you.

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psiXchange brochure psiXchange infographic

psiXchange 3.0 encompasses

psiQ - embedded PV regulatory intelligence

psiQ is an embedded regulatory intelligence “brain,” making up-to-date clinical trial safety reporting expertise available at your team’s fingertips. Actively updated by our global team of experienced PV experts and easily configurable with your own regulatory intelligence.

Fully automated distribution

End-to-end automation of the complex 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.

psiCentral smart portal

psiCentral provides a user-friendly smart portal for all recipients - supporting day-to-day business for recipients and helping to ensure that everyone involved in the process is working from the same information at all times.

psiXchange 3.0 key features and benefits

Includes 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
Helps reduce the time, effort, and compliance risk involved in 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
Enables the viewing, downloading, and acknowledging of safety reports, and provides an overview of all 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”
Requires no programming knowledge and is built by safety and clinical professionals, helping improve clinical trial safety compliance and site responsiveness rates, while reducing operational costs involved in safety reporting
Offers flexible delivery and pricing options to meet the needs of small organizations to global biopharmaceutical companies and contract research organizations (CROs)

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Customer challenge

The Safety Alert Reporting team at a leading global research and development pharmaceutical company is enjoying measurable benefits from using psiXchange. Previously using a home-grown database to serve its regulatory intelligence needs, evolving this had proved cumbersome for the team – requiring a high degree of manual effort. The team needed a solution that could automate and efficiently manage distributions.

psiXchange provides regulatory intelligence detail that other vendors simply don’t offer.

Global pharmaceutical R&D leader

psiXchange solution

The psiXchange system provided a level of regulatory intelligence detail that other vendors simply don’t offer. Our customer is now able to fully customize its reports, specifying the output precisely and getting information quickly in an aggregated form. Manual effort has been significantly reduced - with confidence that the system is pulling in the right recipients every time.

Platform for growth

Today, psiXchange is delivering a proven benefit in the team’s ability to issue a high volume of reports, with positive feedback from end-users and stakeholders. In an evolving industry with changing regulations, maintaining compliance with clinical trial safety reporting requirements, while ensuring that end-users are happy is an ongoing challenge – one that psiXchange is helping our customer to achieve.