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What is psiXchange?

Optimise your PV reporting

psiXchange entirely automates the complex distribution process for your critical safety documents.

psiXchange dramatically simplifies and streamlines the sending of ICSRs and aggregate reports to sites, ECs and IRBs. Each recipient can receive documents in their own preferred way (fax, e-mail, courier, smart portal), ensuring acceptance. This seamless efficiency delivers significantly reduced costs and measurably increased regulatory compliance.

Watch our video to explore how psiXchange can transform the way your organisation handles critical Safety Document distribution - with full audit trail, automated reminders and complete oversight.

psiXchange brochure

psiXchange infographic

psiXchange is the only software available for SUSAR distribution that was designed and built for this exact business requirement. It automates the entire end-to-end process, delivering greater oversight, reduced manual effort and significant cost savings. Used by leading pharmaceutical companies, large biotechs and top 10 global CROs, psiXchange is the intelligent solution to safety document distribution and compliance.

Challenges with legacy approaches

  • Ongoing manual study-by-study maintenance efforts
  • No flexibility with distribution methods, and no ability to deliver to ECs, IRBs and agencies (unless they use a portal)
  • Huge maintenance overhead for user account management and support
  • No compliance oversight across projects for all recipients

To address these unique challenges, we worked with a leading global pharmaceutical company to build psiXchange from the ground up. We now provide an essential, industry-leading software platform that enables delivery to any recipient, using whatever method they require - ensuring global system acceptance and reduced manual effort.

psiXchange optimises the SUSAR distribution process and minimises the number of SUSAR distributions to individuals by combining multiple elements into a single distribution

psiXchange enables SUSARs and other safety documents to be sent in from any external system and then automatically dispatched out to sites and ECs, together with full tracking and a detailed audit trail.

psiXchange connects with existing data sources - including Oracle Argus, ArisGlobal, IMPACT, Siebel Clinical and Veeva Vault -  and accepts documents in any format (such as XML, PDF, XLS). 

psiXchange empowers organisations to overcome traditional manual obstacles, and to track progress in real time. As a result, your team will be able to proactively manage receipt acknowledgements and oversee distribution from a user-friendly dashboard.

Suspected unexpected serious adverse reactions (SUSARs) - reports of incidents that occur during a clinical study - must be distributed to national competent authorities and a number of other recipient groups, such as Ethic Committees or Institutional Review Boards, in addition to investigators participating in the respective studies.

Multiple documentation recipients must be informed using specific formats, and the content must also be blinded or unblinded according to given regulations. Beyond these standard requirements, psiXchange further optimises the SUSAR distribution process by:

  • Always using current recipient lists from master systems - for example, a CTMS - without additional administrative overhead
  • Enabling cross-reporting - minimising the number of SUSAR distributions to individuals by combining multiple elements into a single distribution
  • Creating correct retrospective reporting considering the latest IB content (for example, when a new investigator joins an ongoing study programme)
  • Capturing all activities in a comprehensive audit trail
  • Ensuring minimal administrative effort in set-up and maintenance of SUSAR distributions
  • Assurance of low learning curve and high acceptance rate for recipients, without the need for formal system training
  • Automatically generating cover letters, plus collecting and tracking acknowledgements
  • Offering defined escalation schemes with alternative distribution routes
  • Providing full monitoring and alerts capabilities
  • Supporting manual interventions, such as a manual resend
  • Delivering robust reporting capabilities

Customers who have implemented psiXchange for automated SUSAR distribution report up to 80% reduction in costs, and up to 90% reduction in resource requirements while experiencing regulatory compliance rates above 97%.

psiXchange – Compliance Through Automation

psiXchange is a reliable, fully automated system that delivers efficient management of pharmacovigilance reporting obligations - as used by some of the world's top contract research organisations and pharmaceutical companies.

Unlike rule-based systems and portals, the set-up and maintenance for SUSAR distributions is fast and efficient. psiXchange can work with any document from any third-party system and any database - with no modification of existing systems or existing data required.

Data acquired from different source systems is cross-validated before use in the automated SUSAR distribution process. psiXchange is uniquely flexible and scalable in the number of parameters, or data relations, that it can incorporate within the SUSAR distribution process. This allows the system to seamlessly adjust to any fine-grained process needed (such as the increasing requests by ethic committees to avoid over-reporting). 

Several standard methods of distribution are available with psiXchange, depending on the recipient’s preference:

  • e-mail with secure link
  • e-mail with attachment
  • fax
  • courier
  • smart portal 


  • is available, but often from multiple, disconnected sources
  • can be partially duplicated
  • e.g. Safety Reports, CTMS, contact lists, country rules


  • is information put into relation and structure
  • links information to a purpose
  • often resides with individuals and is not well documented
  • e.g. Compound in Safety Report and Study that INV is working on


  • can be taken on documented knowledge consistently
  • relies on stable data relations
  • provides efficiency through automation
  • e.g. Send an alert to a user at a site with the ICSR details


  • is executed through audit-trailing and monitoring
  • delivers certainty on continued flawless execution
  • comes with minimal overhead
  • e.g. Use the built-in compliance reports to have full oversight

Why choose psiXchange?

psiXchange uses stable data relations, which massively reduces the maintenance effort inherent with rule-based systems. In contrast to Service Oriented Architecture (SOA), psiXchange is a complete business solution and not just a set of infrastructure components. Unlike Extract, Transform and Load (ETL) based systems, psiXchange is designed for business users, not programmers.

psiXchange provides full end-to-end business process automation - delivering a complete, fit-for-purpose solution platform and not just another portal or delivery method.

psiXchange links the information held in your organisation's safety database with your contact data and specific country rules to provide a transparent distribution process that requires no manual intervention. The relationships between these different sets of data drive the process - meaning that your team can focus on ensuring oversight of compliance instead of managing complex, multi-recipient SUSAR distributions.