Kickstart Study Start-up Performance: Insights from Allergan and Johnson & Johnson

The State of Study Start-up in 2020
Study start-up is a critical component of the end-to-end trial process, yet it continues to be a challenging area for clinical operations teams. Research shows the average time from site identification to activation is 7-8 months, and it takes 4-6 weeks longer today to execute study start-up than it did 10 years ago.1 As companies become more global and grow through mergers and acquisitions, the number of clinical trials and systems increase, as do country, ethics, and regulatory requirements. With the rise of personalized medicine, protocols are also increasing in complexity. Excel trackers are ill-equipped to manage such intricacies, resulting in process and data silos that impede collaboration and add to study timelines.

How do two global top 20 pharma companies manage these complexities and improve start-up performance? Lorena Gomez, global director of study start-up at Allergan, and Sandy Freeman, GCO U.S. director MAO supported studies at Johnson & Johnson, share their insights on opportunities to accelerate study start-up and how their organizations leverage Vault Study Startup to maximize efficiency and effectiveness.

The Foundation of Study Start-up: People, Process, and Technology Pillars
Both Sandy and Lorena agree technology isn’t the sole solution to improve study start-up – people and processes are also vital. Technology can be an enabler of change, but people and processes must also be aligned, as a failure in any of the pillars can cause a breakdown. Technology must work in concert with collaborative people and flexible processes to ensure high-performance study start-up teams. According to Lorena, a constant feedback loop from those involved in daily start-up operations is crucial to adjust processes and technology accordingly.

Driving Change: The Vault Study Startup Journey at J&J
A big component of successfully improving study start-up is change management across all three pillars. Relationships with sites became a major focal point for J&J on their journey to faster study start-up. J&J has given sites access to Vault technology to streamline site interactions, resulting in a 70% decrease in time for site essential document exchange. They’ve also eliminated the back-and-forth file sharing over email, saved on mailing costs, and study teams can now deliver country documents, templates, and protocols with ease to sites – all while improving visibility and compliance. Sandy emphasized the importance of training sites, which highlighted the ease of use of the technology and benefits for them, ensuring high adoption of Vault.

J&J also invested time during implementation creating reports for upper management to ensure they have real-time visibility to the KPIs and KRIs they need. Because J&J no longer relies on data compiled from multiple Excel trackers, senior leaders are confident the data is accurate, driving informed decision-making. J&J reconfigured their processes to fit their new approach to study start-up, helping them work more effectively with sites and enroll patients faster.

The Benefits of Streamlined Study Start-up at Allergan
Allergan embarked on a technology transformation initiative to replace multiple Excel trackers and manual processes to improve visibility and transparency company-wide. Rather than taking a phased approach, Lorena and her team implemented Vault Study Startup and Vault eTMF together. Allergan no longer must manually upload documents to their TMF because site documents are automatically filed in Vault eTMF, which saves Lorena’s team hundreds of hours of time, especially during quarterly TMF reviews.

Now that Allergan has a purpose-built study start-up solution, they can view historical metrics, store reusable documents such as CVs, generate reports across trials, and collaborate directly with sites to speed document collection. Users can securely log in to Vault Study Startup and check study progress at any time, providing visibility to all study start-up activities, from site identification through to activation.

What’s Next for Study Start-up?
As Lorena looks ahead, she sees the standardization of big data as a key opportunity across the industry. Leveraging information about investigators, sites, and countries in a consistent way can help better predict ideal site placement, investigator performance, country and site start-up timelines, enrollment potential, and more.

Strengthening relationships with sites to drive improvements in study start-up is the focus for Sandy and J&J. They continue to optimize the site experience to foster better collaboration, transparency, and visibility.

To learn more study start-up process optimization techniques, best practices for change management, and actionable tips for an effective study start-up deployment strategy, watch this on-demand webinar with Allergan.

1 Lamberti, MJ, Chakravarthy, R, Getz, KA. Assessing Practices & Inefficiencies with Site Selection, Study Start-Up, and Site Activation. Applied Clinical Trials, August 2016