Building the New myClin Brand

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?

“The secret of change is to focus all of your energy, not on fighting the old, but on building the new.”

These words are from a character named Socrates in a book published in the 1980s by Dan Millman (and not from the renowned Greek philosopher!). This seamless and constructive transition from old to new is precisely the spirit in which we’ve created the new myClin brand.

This change marks a significant milestone in our journey, providing an opportunity to reflect on everything that myClin stands for and everything that we aspire to become as we move forward.

From old to new

The former myClin brand identity was the reflection of our initial focus on collaboration. More than a decade ago, we set out to build the best platform possible for clinical teams to collaborate remotely, exchange key documents, manage remote training, and stay in sync at all times.

After years of interacting with our customers and observing the shifts in the industry regulatory context, a higher value proposition had realized itself. myClin was not only a productivity and a collaboration tool, it had also become a leading Clinical Oversight platform. When switching to myClin, our customers were freeing themselves from duplicate and tedious Clinical Oversight tasks. Even small biotech firms with limited bandwidth were able to produce complete, definitive and contemporaneous evidence of Oversight, without having to think much on it. Running a study with myClin was in effect creating a complete track record. Preparing for FDA inspections didn’t involve weeks of digging in old emails, but rather reviewing and producing the data readily available on myClin.

The meaning behind our logo

Our new logo and visual identity are inspired by the core principle of Oversight while alluding to collaboration in its link-like shape — not only helping study teams work together in a unified environment but also attain a new degree of Oversight.

We’re proud of what the system and the company have become and this logo embodies the new image of myClin. It represents our transformation and projects a more modern and established picture of the company and the system.

A new path forward

As you can see, it is not just our logo that has changed. The focus on Oversight has been a driving force behind the company strategic decisions, the myClin system development roadmap, and our sales and marketing campaigns.

We’ve updated our messaging, website and all marketing channels across the board to make the brand experience delightful and consistent, and better reflect our focus on Clinical Oversight and Compliance.

Some things won’t change

Behind the new look we are still the same team, dedicated to providing you cutting-edge software and outstanding support.

We’re proud of the work that we do at myClin and thankful for the employees, the partnerships, and clients that have accompanied us in our growth. All this has been a lot of work and we’re excited to share this with you. Please feel free to reach out and tell us what you think!