Hindered Site Visits? myClin Enables Reliable Communication and Remote SDV Support

In a business niche as highly critical, closely scrutinised and heavily regulated as pharmacovigilance it remains a puzzle why clinical development organisations struggle so often with the “end of process task” of distributing Safety Reports*. These are commonly known as Suspected Unexpected Serious Adverse Reaction or SUSARs. Timely safety report distribution is important because of its part in improving patient safety but also due to the compelling regulatory obligation to distribute this material promptly.

A Pharmacovigilance Process Summary

  1. Site reports Serious Adverse Reaction (SAR) within 48 hours.
  2. Sponsor determines if SAR is unexpected or not.
  3. Sponsor reports SUSAR to relevant regulators within days (for EMA within 7 days and typically 15 days for the FDA).
  4. In parallel to step 3 the sponsor has a responsibility to promptly inform other sites once the matter is identified as a safety issue. While there is some scope for interpretation here, “promptly” is normally interpreted as meaning a number of days and not some longer period of time. Typically sponsors will aim to distribute safety reports within 15 days.

For reference here is how the FDA explain things – p16 of FDA Guidance Safety Reporting Requirements for INDs and BA/BE Studies.

The reality is that this end of process task sounds simple to define but it is in fact pretty complex and time critical. In addition – organisations are often so blindly addicted to using email that alternative, more dynamic and reliable means of information distribution are strangely alien and fantastical. But why not use distribution means that allow for active information distribution, with real-time dynamic readership information? In an age where audience behaviour is closely tracked, isn’t it time you knew who has read your latest Safety Report, and more crucially who has not?

Continuing the execution of your clinical trial(s) during the coronavirus pandemic is just one daunting aspect of this global situation. Actually starting a new trial during lockdown is even more challenging. In the spirit of sharing good news and peer encouragement here we briefly illustrate some encouraging anecdotes from our customer base whose Clinical Operations have proved sufficiently resilient during the pandemic for them to both continue existing trials and start new ones.

This is not to say for a moment that these actions were easy or trivially achieved. While their use of the myClin Clinical Oversight Platform is a common theme much more important is the good human practice these teams are applying. There is an essential flexibility and innovative spirit in their approach that has been key to their success – a flexibility that has been matched by the regulatory responses they received.

So how can you execute a clinical trial when you can’t visit a site?
And the inability to visit your sites is likely to strike in the future too as various geographies might be forced into renewed “second wave” lockdowns. There are 2 main ways myClin has helped.

First, controlled and reliable communication between all study stakeholders. Suddenly the delivery of essential study information is a task your monitors cannot perform. So how do you deliver that important study update? More challenging, how do you train a site from scratch when starting a new study?

The myClin tool helps because:

  • Readership of all study documents and communication is transparently reported and shared.
  • A range of online training can be delivered efficiently.
  • Receipt and acknowledgement of essential study documents is tracked.
  • Users at sites and in your clinical team are led to the items that require their attention.
  • Study management can quickly see which staff are paying good attention and those that need encouragement (myClin Compliance Score).

The second use case is support for remote SDV (source data verification). As a highly flexible storage tool for clinical documents, sites are uploading copies of source documentation into myClin. This content is suitably redacted by the site. The monitors are then able to review this source material alongside the eCRF data and continue to fulfil their SDV duties in a timely and targeted manner. All with the in-built audit trail and view tracking that is normal to myClin.

For the studies that were already underway this change of process has been discussed collaboratively with regulatory bodies. Those bodies have understandably been sympathetic to efforts to continue trial operations through the pandemic – patients still need treatment and care through all of this.

Good luck in your own efforts to continue study operations despite this unprecedented health crisis.

By Adam Wood, VP, Business Development at myClin

About myClin: Are you really ready for an inspection? Start using the myClin platform to take control of intricate and error-prone study documentation. Keep essential information at your fingertips to stay audit-ready at all times. Get started with more free resources and a demo at myClin.com

About Clinical Works: Are you ready to move faster and smarter with a high impact, curated ClinOps team? We help new bio-pharm ventures and start-ups bridge the gap from investment to clinical development. Find out more at clinical.works