make your data workpsi change

Over the past five years, psiXchange has changed the way that organizations manage all aspects of Safety Document Distribution.

From the initial product design, through to the most current releases (more of which are described below), psiXchange has implemented a true “first principles” development strategy where the starting point has been the business requirements and the software has been built to meet those requirements.

So, unlike any of the other software that is currently available to support this use case, we did not take an existing product and attempt to retrofit it to make it work for safety distribution.

psiXchange is therefore in a unique position as the only commercially available software dedicated to Safety Document Distribution which allows us to introduce functionality that our customers have benefited from without being limited by a specific technology stack or being configured by the core product development life-cycle.

psiXchange: Improving Document Distribution by Design

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White Paper psiXchangeImproving Document Distribution by Design

We know from speaking with customers that a generic site portal, or investigator training platform that's been squeezed into doing different things, cannot properly meet the regulatory demands that are associated with Safety Document Distribution.

So, at the heart of our latest release of psiXchange is a module, specifically designed for managing the country specific rules for any document types for all potential recipients.

This integrated module, with a full audit trail, includes a formal approval step for any changes to the country rules, together with multi-level exception handling as needed.

By embedding this knowledge base (over which each customer has full control and oversight) we take the first step towards driving the automation of the entire distribution process.

This integrated module, with a full audit trail, includes a formal approval step for any changes to the country rules, together with multi-level exception handling as needed.

We very often then seen huge manual efforts associated with the contact management activities for these safety notifications.

These typically start with the creation of distribution lists on a document by document basis prior to uploading to the portal. Significant efforts are often then expended in managing the poor-quality data received from others (internal teams, or external third parties).

To address this, psiXchange has a Clinical Trial Module where you can upload and maintain your contact data. This allows for the built-in quality checking of the records and additionally provides further flexibility to manage specific attributes for each contact that are not typically found within a standard CTMS (for example the preferred method of receiving data, or the assigning of a specific local contact to an Ethics committee).

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White Paper psiXchange

Global contacts (such as ECs, Health Authorities and IRBs) can also be maintained within CTM so that a complete list of potential recipients within a study is captured in one system. psiXchange creates the specific distribution lists itself for each safety document as it receives it, taking a further step towards end to end automation.

If you prefer to maintain your contact data outside of psiXchange, in your own CTMS, then you can do so with ready to use integration. Our customers are currently doing this with many of the leading CTMS.

The source documents themselves (ICSRs, aggregate reports, in fact any document) can be sent to psiXchange directly from any third-party system including Argus, SafetyEasy PV and ArisG. Or, these reports can be uploaded via ready to use masks within a web browser, giving you complete flexibility according to your preferred process.

psiXchange uses the information that it understands about these safety documents (IMP, Blinded Status, Country of origin etc.) combined with the country rules and list of potential contacts to create a document specific distribution list automatically. This is an entirely hands-off process.

You simply upload a document (or send it directly from your safety database) and psiXchange sends out the required messages to the relevant recipients.

Improving Document Distribution by Design

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White Paper psiXchangeImproving Document Distribution by Design

The messages that are sent out are then tracked, with a detailed audit trail, allowing you to drill down from a document to see who it was sent to. Or, you can start with a view of a recipient and see what was sent to them, and the status of every message that was ever sent.

You can do this from your own custom dashboard, with your preferred views on the data ready to explore and check on compliance.

If we consider what the messages that psiXchange sends out look like, then it will depend on what recipients would like to receive.

This is another unique advantage of the psiXchange approach. We didn’t want to start with a portal and then force recipients to learn how to use it (but with a fallback of some other method if the portal didn’t work). Instead, we focused on ensuring that our flexible application was welcome by sites, EC, IRBs, HAs in fact anyone who needed to receive safety documents.

This meant allowing for recipients to get the right documents, at the right time, but in their preferred way. All distributions are still tracked in a central dashboard, regardless of delivery method, allowing you to have a complete oversight on compliance in one place. Messages are automatically grouped according to your preferences to avoid bothering recipients with too many alerts.

The messages that are sent out are then tracked, with a detailed audit trail, allowing you to drill down from a document to see who it was sent to, and when it was acknowledged.

The delivery methods that we support include:

– e-mail with secure link (direct to the document, no sign on required)

– e-mail with attachment – FAX – Courier – Safety Central” our smart portal

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White Paper psiXchange

Our customers rely primarily on our e-mail with secure link method for delivering their safety documents (99% of deliveries are sent this way). It’s been embraced by all recipient types and the unique link that is provided in each outgoing message ensures strong security and powerful tracking capabilities. The addition of Safety Central in this release offers even more flexibility. No study by study internal efforts are required to send documents to Safety Central and recipients connect using One Time Passwords (that are sent on request to a registered e-mail address).

Recipients can then review all alerts sent to them, and optionally read and download all safety letters, in a study specific “inbox”.

All receipt tracking (for all methods) is not onerous for the recipients themselves (as it’s fully automated) which means high acceptance by sites and others.

Your internal team can access the most important reports from their dashboards and look at the status for a specific safety document, or site, or recipient and easily share the information with others in team as needed.

From start to finish our approach has been to ensure that complete flexibility, within a controlled framework, is the best way to allow you to regain control of this complex process. This means allowing you to decide how you want to manage country rules, contact data and safety documents (inside or outside of psiXchange) and for you to decide how each document should be delivered according to the preferences of your different recipients. By providing these options, together with a centralised oversight and reporting module, you will immediately benefit from reduced manual efforts, reduced costs and increased compliance.

Our customers rely primarily on our e-mail with secure link method for delivering their safety documents (99% of deliveries are sent this way).

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White Paper psiXchange

About pharmasol

pharmasol is a leading provider of innovative applications, GxP compliant hosting and implementation services to the life sciences industry. With tools to automate complex business processes and the deployment of applications in a secure managed data centre, pharmasol is trusted by leading pharmaceutical, medical device and contract research companies to support their core business processes and ensure compliance.

To learn more about us visit our website at: www.pharmasol.de

If you are interested in further information or would like to arrange a demo, please contact:

Tim Billington tim.billington@pharmasol.de +44 (0)7768 336 302

Or visit our website where you can find further information about the product:www.psixchange.com

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