Send the right safety document to every recipient on time
A single suspected unexpected serious adverse reaction can require distribution to investigator sites, ethics committees, competent authorities, notified bodies and institutional review boards, each with its own format, language and deadline. Done by hand, it is slow, and it is where compliance risk concentrates.
This tool automates the whole chain. Distribution rules maintained by pharmacovigilance experts decide who receives what, cover letters generate in local language, and every acknowledgement is tracked in one place, so your team monitors the process instead of running it.
This tool automates the whole chain. Distribution rules maintained by pharmacovigilance experts decide who receives what, cover letters generate in local language, and every acknowledgement is tracked in one place, so your team monitors the process instead of running it.
Take the manual work out of safety distribution
Safety reporting has grown faster than the teams doing it. Case volumes rise, requirements shift country by country, and the knowledge often sits with one or two people who are not always there.
Requirements that keep moving
Reporting rules differ by country and change without notice, so staying current is constant work and falling behind is invisible until it matters.
Manual distribution at volume
Rising case volumes meet fixed headcount, and skilled safety staff spend their time on rote distribution rather than on the work only they can do.
No single view of status
Compliance status is scattered across inboxes and spreadsheets, so nobody can say quickly which recipients have received the documents and which have not.
Automated distribution, embedded intelligence and a shared portal
You get end-to-end automation of distribution, tracking and acknowledgement for clinical trial safety documents sent to sites, ethics committees, competent authorities, notified bodies and institutional review boards.
Embedded regulatory intelligence keeps the distribution rules current, cover letters generate in local language, and recipients work from a shared portal rather than their inboxes.
Embedded regulatory intelligence keeps the distribution rules current, cover letters generate in local language, and recipients work from a shared portal rather than their inboxes.
What we offer
Automated distribution
End-to-end distribution of safety documents to every recipient type a study requires, in each one's preferred format.
Embedded regulatory intelligence
Country reporting rules maintained by pharmacovigilance experts and applied automatically.
Acknowledgement tracking
Real-time visibility of who has received, viewed and acknowledged each report, tracked against timelines and priorities.
Recipient portal
A shared portal where recipients view, download and acknowledge safety reports from one source of truth.
Investigator brochure library
A searchable library of brochures and safety information, replacing the assembly of separate document packs for each study.
Safety system integration
Connects to leading safety databases and clinical trial management systems, accepting documents in any format without re-keying.
Why choose Cencora for safety document reporting
Expert-maintained rules
Distribution rules are maintained by pharmacovigilance specialists, not left to software alone, so requirements stay current.
Shared team knowledge
Reporting knowledge lives in the system rather than with one or two people, so distribution continues when they are away.
Less manual effort
Scale support for new projects, ad hoc requests, and multi-study programs without rebuilding internal operating models.
Expert insight
By delivering centralized coordination and visibility, with full flexibility for specific local needs, automated solutions are proving to be effective for improving efficiency and accuracy of PV operations.
— Iain Barnden
How automation increases efficiency and accuracy of local PV monitoring and KPI tracking
Related solutions
Clinical trial pharmacovigilance activities
Manage clinical trial safety activities with expert support for adverse event processing, safety writing, and compliant submissions across global studies.
PharmaLex is now Cencora
Safety document reporting tool (psiXchange) is part of our Commercialization support capability. Same team, same expertise, now with greater reach.
Need more information about clinical safety reporting tool (psiXchange)?
Our team of experts is here to assist you. Whether you have questions or need more detailed information, don’t hesitate to get in touch. We’re dedicated to providing the support you need.