Montrium

You’ll want to be sitting down for this one. Grab your popcorn, because we’re about to dive into the top 10 scariest things you could say to a clinical research professional. Have your own clinical research horror story? Let us know in the comments! 👻

There are three key things to consider when making any major changes in your organization. 🔑 And guess what? They’re all intertwined. 🧍 People: Don’t forget people along the way. Remember that each individual within your organization has their own experiences, feelings, preferences, and so much more that will factor into the transition. 🛠️ Processes: With mergers and acquisitions, there will be many processes to choose from. With so many different approaches to managing a TMF available to you, why not choose the most efficient one? 💻 Technology: It’s constantly changing. No matter how advanced you think your organization might be, there will always be new developments on the horizon. Is your technology working for you, or are you working for your technology? Make sure you cover ALL of your bases during a merger or acquisition, not just one or two. How has your organization handled mergers and/or acquisitions? Good or bad, let's help one another learn from experience. 👇

Don’t let your TMF fall behind during a merger or acquisition. With the correct framework, you’ll be able to get up-to-speed in no time. First thing’s first, different stages require different approaches. Let’s dive in. 🚶♂️ Pre-merger/acquisition: Time to look under the hood of the TMF. Check to see that the TMF was maintained in a compliant system, and that all metadata is included with documents. If it’s not, you could be breaking audit trails. 🚴♂️ Harmonization: Conduct a TMF gap assessment. Find out what is missing, what has been done, and what still needs to be done. Leverage existing teams and processes rather than overhauling them. And be sure to include all stakeholders, including leadership, as well as quality, IT, systems and regulatory teams. 🚗Integration: There are a lot of moving parts here, and the first thing you will want to focus on is defining your processes. As much as you try to avoid chaos, a little bit of it is inevitable. Who on your team can keep a level head in the midst of organized chaos? You may lose some people along the way for reasons that have nothing to do with your TMF. It’s normal. Just be sure to capture knowledge when you have all the personnel at hand. ✈️Optimization: Continuous improvement is the name of the game. It’s what regulators are trying to see during inspections. How are you improving? Nobody is perfect, and if you think you are...things change. Create your storyboards as key events are happening, not after the fact. 🚀Keep it up and you’ll be ready for inspection. How has your organization handled mergers and/or acquisitions? Good or bad, let's help one another learn from experience. 👇

“TMF inspection readiness is just making sure you have all the documents!” ...said NO ONE EVER. 🙅 The TMF is the basis of an inspection and is often not given the time and attention it deserves. There’s a lot involved in getting your TMF ready for inspection, and it often begins with a simple mindset change. The burden is on life science organizations to provide awareness and education for the importance of the TMF. One of the best ways to do this is by designating a TMF champion, or someone who can lead TMF-related initiatives and ultimately ensure the long-term success of the clinical trial. 🦸♂️ Show your TMF Champion some love by tagging them in the comments below! 👇

🛑 Hold up! Just a routine scroll stop. 🛑 If you’re thinking about ways to refresh your TMF management plan, you're going to want to put the traffic light approach to work. 👇

The call is coming from inside... the office?   Just in time for spooky season, here's what people think QA does all day 👻 Let us know in the comments whether you think this is accurate 👇

“One size fits all” should NEVER be used to describe a TMF metrics program. Your clinical trial is unique. Your stakeholders are unique. Why would you try to implement a stock TMF metrics program in order to gather unique insights?

Audit trail reviews 🤝 data integrity Managing a TMF? You should consider audit trail reviews. Audit trail reviews will help you uncover anomalies standing in the way of the data integrity you want to ensure. Here’s what Donatella Ballerini has to say. 👇

As the saying goes, there’s more than one way to cook an egg. The same goes for your approach to TMF QC. You ALWAYS have options. To optimize the quality check process, 2 distinct but impactful approaches can be followed: One focusing on a second level of risk-based QC with a preliminary check on 100% of documents, And the other applies a risk-based approach at the first level of QC. Here’s what to consider when selecting the right approach for you: 💡 Trial complexity: High-risk trials may benefit from a more comprehensive initial QC. 💡 Resource availability: Limited resources may steer teams toward a more targeted risk-based approach from the outset (first level of QC). 💡 Regulatory landscape: Adherence to specific regulatory requirements may influence the chosen strategy. 💡 GDocP knowledge: QC applied only to a portion of TMF documents can be more effective if we can ensure that document owners are trained and prepared on what ALCOA++ principles are. 💡 Lessons learned: The experience with past TMFs can teach us that 2 levels of QC are better than 1. 💡 Internal processes: Company SOPs and WIs can be robust enough to support the approach of a second level of QC based on the RBA. 💡 Quality trends: Regular assessment of TMF quality issues can lead to a more valuable second-level RBA to QC (typing errors are not comparable to patient identifier errors). Read the white paper to learn more: https://lnkd.in/eV3f5wQc

⏰ HAPPENING NEXT WEEK⏰ We can’t wait to see all you clinical trial professionals at the Outsourcing in Clinical Trials New England event in Boston! This year's event will boast 4 tracks on clinical operations and outsourcing, clinical technology and innovation, rare diseases, and patient recruitment and engagement. If that weren't exciting enough, the Montrium crew Danny Gold and Oliver Pearce will be there to chat with you about solutions for your eClinical tech needs. Stop by booth #8 to see what’s new at Montrium and snag some of our famous merch. Heading to OCT New England? Let us know in the comments so we can be on the lookout for you! 👇