Trifecta User Forum Meeting Summary
SCOPE 2018 February 12th 12-4PM Hyatt Regency Orlando, Florida
Trifecta was pleased to host its first Trifecta User Group Forum just before the #SCOPE2018 conference commenced in Orlando. Thank you to all who participated for sharing unique insights, successes and challenges that will help Trifecta better serve your clinical trial training, safety and communication needs both now and in the future. Below are a few of the highlights from the User Group Forum, attendee list and technical information shared. If you would like further information or to express interest in attending one of our future Trifecta User Group Forums, please reach out to firstname.lastname@example.org
Deb Jednachowski, Sr. Manager, Clinical Safety Notifications, Astellas
Rhonda Ehmann, Director of Site Feasibility and Recruitment, AstraZeneca
Michael Watkins, (former) Director of Global Clinical Operations, Eli Lilly
Ralph Lee, Site Director, Irvine Clinical Research
Samantha Bush, Learning Specialist, Enterprise Learning, PPD
Leanne Heaton-Sims, Principal Performance Optimization Specialist, Enterprise Learning, PPD
Sylvia Eberhardt, Shared Investigator Platform and Investigator Registry Business Lead, Roche
Hal Mann, Director, Clinical Operations Trial Support & Strategic Outsourcing, Roche Molecular
Maggie Adamski, Director, Global Feasibility-Site and Patient Access, Syneos
Christy Wilkerson, Manager, Safety and Pharmacovigiliance, Syneos
Melissa Buck, Manager, Document Management and Training, Teva
Michelle Moran, Director, Trial Optimization and Standards, Teva
Ericka Atkinson, Vice President, Delivery Operations, Trifecta
Rick Ward, Vice President, Commercial Operations, Trifecta
Dave Young, CEO, Trifecta
Agenda Topic 1: Adoption of Technology for Study Start
“On the topic of change management, does it need to come from the top down or the bottom up? I believe it needs to be the two together. The embracing of technology needs to come from senior management, but at the same time, you need ambassadors. You need your project teams that have experienced it, recognize the value and can share it with others. These ambassadors can extend to sites as well.”-CRO Attendee
After introductions and goals for the meeting were discussed, the group jumped into a robust discussion around the many benefits that can be achieved when organizations adopt technology to automate workflow such as investigator training, document distribution and site initiation. The group was quick to acknowledge the reality that, in spite of the positive attributes of new technology, implementation often involves organizational risk. Among the many stories and thoughts shared, change management was the most often mentioned as key to mitigating risk. Involving the right stakeholders early and throughout the process, ensuring project management teams are equipped with the right resources, and reducing the burden of additional processes to target a “single source of truth” were discussed by the group at length.
Agenda Topic 2: Third Generation Safety Letter Delivery
“The enhancements from Trifecta for safety letter delivery will make everything easier for investigators.”-CRO Attendee
The second topic of the Forum was focused around Safety Letter Delivery starting with a look back at first (mail/fax) and second generation (batch email) delivery as well as a current assessment of how third generation safety letter delivery can be implemented to provide streamlined processes and reporting that deliver significant efficiency and savings. One sponsor team shared insights of their own implementation and experience as users combining the power of Trifecta’s SafetyVigiliance® and on demand training solutions:
“We are able to have confidence in a platform like Trifecta to show our records very simply. When it comes time for an inspection, and the inspector is seated across the table, it is very easy to produce a report with Trifecta. Due to this ease, my organization now requires such a platform. Huge lesson learned across our organization. No study is done without it.”-Sponsor Attendee
Agenda Topic 3: Operations Update
“The build out of our new 5,000 sq. ft. studio has made the way we are capturing training even more dynamic and is making a huge impact with our clients. The sky’s the limit.”-Ericka Atkinson, VP Ops
After the afternoon break, Ericka Adkinson, Vice President Delivery Operations shared an Operations Update with the group. She shared the details behind Trifecta’s new business Operations Center in Downtown Indianapolis. The 12,000 sq. ft. office is now home to the Trifecta Operation and Commercial teams as well as a state-of-the-art production studio. The production studio provides simplicity for clients to capture, produce and make training available online to deliver a wide variety of clinical trial training. In addition to the studio space with a large, professionally pre-lit two-sided green screen, the production studio also features a full-scale control room with separate green room, rehearsal and makeup areas. Ericka also shared quality and project management updates including significant investments that Trifecta has made in the last 12 months to ensure overall software and information quality and client satisfaction.
Agenda Topic 4: The Road Ahead-Moving Further, Faster
“In our discussions with clients to develop InvestigatorSpace Mobile, the clear pain point was inspection readiness. Using Trifecta’s InvestigatorSpace® platform, Sponsors and CROs could document training completed on demand but also capture F2F meeting training as well as certificates of attendance. The one nagging gap? Amendment and training documentation gaps. Now, with IS Mobile, the InvestigatorSpace platform is truly a single source of truth. When deployed 100% end-to-end, it captures all of your training events and documents them in one place.”-Rick Ward VP Commercial Operations
“I just came back from an investigator meeting where I used Trifecta’s hand held tablet (InvestigatorSpace Live) during the meeting. You could save slides on the tablet and have them sent to you afterward, which I thought was great because you could take relevant parts of the investigator meeting and save them for later when you are actually performing the trial. Importantly, this is all completed in a secure and organized way via InvestigatorSpace.”-Site Director
The final formal discussion topic included an overview of Trifecta’s product and innovation roadmap. An overview of InvestigatorSpace® Live & InvestigatorSpace® Mobile as well as robust discussion on other training modalities.
InvestigatorSpace Live is Trifecta’s investigator meeting hand held tablet solution designed to enhance engagement and learning experiences at live investigator meetings. It seamlessly syncs presentation content to individual attendee tablets, offers engagement tools such as customized polling and real time results, eliminates the need for large binders of information and gives audience an opportunity to interact directly with the presenter.
Trifecta also shared a demo of InvestigatorSpace® Mobile, a mobile based application tool that assists CRAs in closing training documentation compliance gaps conveniently from their mobile device. CRAs can view training gaps and collect on screen signatures for an efficient and effective way to help close training gaps and ensure compliance.