Post by Christian Wufka, Director, psiXchange Services
When I started my life in the broad field of Safety & Pharmacovigilance, more than ten years ago, business was still conducted with tons of paper files. On my first days I was assigned to a very nice team responsible for SAE processing and regulatory reporting for a clinical trial (CT).
At that time most of the communication was by email that was printed and filed for final TMF inclusion. Clinical trials were blinded using sealed envelopes, CRF pages were completed on paper, safety reports were sent by courier or fax to Health Authorities, Ethical Committees and sites and sites had to return a signed document to provide acknowledgement of receipt and understanding. Overall this CT work was very cumbersome, especially thinking about the workload associated with Safety report distribution as you had to manually prepare, submit, follow up and track each submission separately.
Cover letters had to be prepared, sometimes with special changes for specific recipients, printed and sorted together with the respective report. At least there were cover letter templates available for each specific recipient type. After sorting cover letters and reports together all packages then had to be checked for correctness before finally being submitted. While standing at the fax machine for hours I was often thinking on process enhancements. Email distribution lists helped but there was still a lot of manual effort necessary. Technology evolved over the years with direct submissions out of the safety databases, usage of portals and reduced requirements for courier submissions.
What was still left was different global regulations. On a regional basis regulation is more and more streamlined e.g. within the EU, but on a global basis there are still multiple different national requirements and even local requirements per recipients like for some local Ethical Committees. In addition, Health Authorities and Ethical Committees, preferred methods of distribution methods may also differ from country to country.
With psiXchange we have successfully overcome these final hurdles. Now we can send different types of safety documents like SUSARs, DSURs, Line Listings and others as required to all types of recipients automatically. Such a submission will follow national requirements. In addition, local forms are attached as required (if predefined) and cover letters can be in the language the recipient prefers in addition to English. Recipients will receive their documents with their own preferred method of distribution like email, fax or courier and all documents are additionally filed in SafetyCentral, a single location which is securely accessible via the web.
Submission and receipt of all documents sent is tracked, depending on the method, automatically, e.g. if someone downloads the received document following the unique download link in the email this is tracked within psiXchange or the recipient simply goes to SafetyCentral and acknowledges all open documents at once. Thanks to this live tracking, reports can be run to check the status of each submission based on sponsor, substance, study or even recipient.
To achieve this, psiXchange needs the data on which the decision for who should receive a document is based. This includes trial specific data as well as contact information and reporting requirements. When talking to customers we often heard that these different types of data are stored in different locations meaning higher maintenance efforts for the PV group. In psiXchange you can maintain this data within the Clinical Trial Module (CTM).
Within psiXchange, a clinical trial is created within minutes. This includes countries with respective authority approvals and sites with respective initiation and closure dates. Study specific contact data is maintained with a good oversight in CTM. You can send initial data from a CTMS system to CTM, upload the data (perhaps from an xls), or enter it manually. Updates can then easily be made within CTM. This is very important as contact information changes occur frequently during clinical trials. CRAs may change, sites are activated or deactivated and sometimes contact details change. In addition to the data itself you have access to charts and tables that provide you with a quick oversight on the data entered.
Reporting requirements can be created with a very flexible system that covers all recipients and document types. This includes all countries clinical trials are conducted in and document types you would like to submit via psiXchange. If there are sponsor, study or contact specific requirements these can also be maintained in CTM. This allows you to manage specific requests from authorities and recipients.
With the use of CTM in psiXchange the automation of safety reporting finally led to an increase in compliance on both sides, senders and recipients due to straightforward handling of the data required for the submission of all your safety documents.