psiXchange is the only software available for SUSAR distribution that was designed and built for this exact business requirement. It automates the entire business process allowing for improved compliance, greater oversight and significant cost savings. Used by leading pharmaceutical companies, large biotechs and top 10 global CROs psiXchange is dedicated to ensuring an improved site experience without the internal headache that this process typically brings.

Challenges with legacy approaches

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

Faced with these challenges we worked with a leading global pharma to build psiXchange from the ground up to address each of them and ensure that we had software that allows for delivery to any recipient, using whatever method they require, leading to global system acceptance and reduced manual efforts.

“It is very helpful if the system supporting the SUSAR distribution process minimizes the number of SUSAR distributions to individuals by combining multiple elements into a single distribution.”

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

We connect with existing data sources, like Oracle Argus, ArisGlobal, IMPACT, Siebel Clinical, Veeva Vault etc. and accept documents in any format e.g. XML, PDF, XLS. With psiXchange, you’ll be able to overcome the traditional (manual) obstacles, and track progress in real time. As a result, your organization will be able to proactively manage receipt acknowledgements and oversee distribution from a user-friendly dashboard.

Suspected unexpected serious adverse reactions (SUSARs) are reports of incidents which happen during a clinical study and must be distributed to national competent authorities and a number of other recipient groups such as Ethic Committees or Institutional Review Boards, but also to investigators participating in the respective studies. Many companies have implemented business rules beyond the regulations to further automate the SUSAR distribution internally and to business partners.

The various recipients must be informed using specific formats and the content must also be blinded or unblinded according to given regulations. Beyond these basic requirements, it is very helpful if the system supporting the SUSAR distribution process allows the following:

  • Always use current recipient lists from master systems, e.g. a CTMS, without additional administrative overhead
  • Cross-reporting
  • Minimize the number of SUSAR distributions to individuals by combining multiple elements into a single distribution
  • Correct retrospective reporting considering the latest IB content, e.g. when a new investigator joins an ongoing study program
  • Capture all activities in an audit trail
  • Minimal administrative effort in setup and maintenance of SUSAR distributions
  • Low learning curve and high acceptance rate for recipients, ideally superseding formal system training
  • Automatic generation of cover letters
  • Collect and track acknowledgements
  • Defined escalation schemes with alternative distribution routes
  • Full monitoring and alerts
  • Support manual interventions, such as a manual resend
  • 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 compliance rates above 97%.”

psiXchange – ComplianceThrough Automation

The review of the “ICH Topic E6 (R2) Guideline for Good Clinical Practice” and the “Clinical Trial Regulation” (536/2014) in the EU expand on the duties of a study sponsor and to a certain extent also investigators, with the basic intent to improve sponsor oversight and quality control. These two closely relate to monitoring and data management which are the topics with the highest number of critical and major findings in the EU in the period from 2000 to 2012 as reported by the EMA.

psiXchange is a reliable, fully automated system allowing for efficient management of reporting obligations and is used by several of the top twenty contract research organisations and pharmaceutical companies.

Customers are directly benefitting from the fact that, unlike with rule-based systems and portals, the effort for setup and maintenance for SUSAR distributions is reduced significantly. psiXchange can work with any document from any third-party system or any database Existing systems, as well as existing data, are not modified.

Data acquired from different source systems is cross-validated before use in the automated SUSAR distribution process.

psiXchange is equally flexible with the number of parameters, or data relations, that it considers in the SUSAR distribution process. This allows the system to adjust to any process needed. One application of a more fine-grained approach is, for example, the request by more and more 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 *new*

psiXchange - The Dynamic Data Hub


Manual

Automated

Data

  • is available, but often from multiple, disconnected sources
  • can be partially duplicated
  • e.g. Safety Reports, CTMS, Contact lists, Country rules
blog icon image - SUSAR

Knowledge

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

Action

  • 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

Control

  • 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
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How does psiXchange compare?

psiXchange uses stable data relations which massively reduce the maintenance effort inherent with rule-based systems and unlike 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 and thus goes way beyond being just another delivery method like a portal.

It links the information in your safety DB, your contact data and the 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 the focus for you is reviewing oversight of compliance instead of figuring out which SUSAR needs to go to which user.

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