Insights and Highlights from Trial Interactive's Inaugural OpTImize Summit

Hosted in conjunction with TransPerfect’s GlobalLink NEXT conference in New York City last month, OpTImize marked the first ever Trial Interactive customer summit. This invitation-only event offered attendees a wealth of content, networking opportunities, product showcases, client success stories, panel discussions and workshop sessions. Optimize brought together guest speakers, industry professionals, Trial Interactive experts, customer success teams, and system users for the very first time.  

Division President Michael Smyth kicked off the event with opening remarks that set a productive tone for the day. First up was an expert panel on establishing a culture of inspection readiness from the inside, moderated by Trial Master File expert Laurel-Ann Schrader. The session cast a large emphasis on TMF culture, which has become an important and timely focus as the industry moves to a state of more agile TMF management. Attendees were encouraged to think beyond systems and processes to get buy-in from functional stakeholders on the importance of the TMF.  

This session was followed by a discussion on inspections, the most important aspect of TMF management. Great insights were shared by panelists and moderator Avani Amin, Associate Director of Client Solutions. The panelists highlighted the inadequacies of functional areas using other systems to store TMF documents. These systems are almost never prepared for the scrutiny of a regulatory inspection.  Stakeholders outside of the TMF team need to be made aware that regulatory inspectors will ask about any ancillary systems containing trials documents. As such, it’s important to ensure these systems are defined as part of the TMF and subject to the same controls. 

Next on the agenda were several sessions intended to maximize attendees' knowledge of the Trial Interactive platform. These sessions afforded users creative use cases, tips and tricks, and unique ways to drive efficiency and enhance compliance with Trial Interactive products.  

Day one concluded with a look into the bright future of eClinical Technology. Our experts foresee the affiliation of the TMF Reference Model with standards organization CDISC, combined with the common protocol template initiative known as M11, being catalysts for increased interoperability and data availability. Machine learning, large language models, and other automations were also heavily discussed.  Those with concerns about AI taking their jobs can rest easy; our panelists anticipate AI developing to reduce manual tasks and allow humans to focus on other areas, particularly creative endeavors.  

Finally, after a taste of TransPerfect’s world renowned hospitality in the evening, our attendees headed into the second day of Optimize. It was important to the Trial Interactive team to dedicate time for attendees to have smaller meetings for networking, product demos or troubleshooting. Day two saw all our SMEs engaged in deep conversations with clients and early feedback pointed to these meetings as a real highlight of the summit.  

After lunch, LMK’s education trailblazer, Jackie Morrill and I kicked off a workshop on TMF risk with a survey of the audience. Showing real time results led to real thought-provoking conversations. One of the biggest takeaways here was the level of emphasis on eTMF training processes that our audience experienced. We are expecting a ton of follow-up from clients that identified risks in their own organizations and TMF processes. 

The next session was an insightful panel discussion featuring current Trial Interactive clients, sharing their journey with us from implementation to current state. An important takeaway here was to avoid underestimating the importance of change management during eTMF implementation, especially if moving from a paper TMF. It was truly wonderful to hear how clients had leveraged TI to the fullest to support that change, turning eTMF skeptics into eTMF supporters in the process. 

Finally, the ultimate session of the event offered a chance for our Trial Interactive customer success champions to discuss the functions of their team and educate attendees on how they support customers in meeting their goals. I think the audience all left feeling that the TI family has a great network of SMEs, champions and leaders to support them in their customer journeys.  

And so, it was a wrap. Trial Interactive’s first customer summit ended, and the consensus is that the event was a great success. All of us here at Trial Interactive thoroughly enjoyed the thought-provoking panel discussions, workshops and sessions, as well as the opportunity to connect face to face with our clients and learn more about their challenges.  

We’re particularly appreciative of all our guest speakers and panelists for sharing their time and expertise, and of course to our attendees for their high engagement and great questions. Division President Michael Smyth closed with a high energy speech that hyped everyone up for next year. Will you be there too?