Contributed Commentary By Ashley Davidson

June 20, 2017 | The pace of drug trials and approvals in the life sciences industry is increasing dramatically. On average, the FDA approved 25 new drugs approved each year between 2003 and 2013. In 2014, that number jumped to 41, and in 2015 it increased to 45. That number fell in 2016 as an outlier, but is already up to 21 this year with more than half of the year left to go. The growing number of trials and approvals is creating significant business complexity, especially in study start-up.

Today, the study start-up process is multifaceted, cross-functional, and global, and involves numerous simultaneous activities across much larger internal and external teams. A 2012 study examined 105 global clinical trials and found that due to the volume of activities required at study start-up, most companies recognize it as a bottleneck and are looking for ways to increase efficiency. Further, the Tufts Center for the Study of Drug Development recently followed up from a study completed in 2009 and found that study startup time is no faster today than it was nearly ten years ago.

One of the causes of delay is inefficient collaboration between sponsors and key partners, often caused by incompatible legacy systems as well as a historically transactional relationship. Transforming study start-up requires the sponsor and CRO relationship to shift from an ancillary customer-vendor model to a strategic partnership, with both parties working together seamlessly, from the beginning, toward mutual goals.

“We focus on the core foundation of building a trust-based relationship,” said Dawn Anderson, managing director of life sciences R&D at Deloitte, which helps sponsors navigate study start-up challenges. “It’s all about accountability, transparency, and communication—and it should be established very early in the process. It takes a lot of effort, but clients that take steps to create a partnership experience the most gains.”

Recently, a top 10 global pharmaceutical company took an innovative approach to transforming how it works with one of its preferred CROs. Creating a more collaborative environment began with the co-selection of a new study start-up platform. Here are the steps the sponsor and CRO are taking together along their journey to transform their study start-up processes.

Integrate Stakeholders Early in Decision-Making

The sponsor first is seeking the input of its CRO early, which is critical given the role of the study start-up platform in the success of their relationship. As part of this effort, the companies have and continue to solicit feedback from all those that would be impacted by the technology—from executives to end users. This allows for mutual buy-in and an early start on change management.

As true partners during the evaluation of the solution, the likelihood of the technology being effectively used after deployment increases dramatically. Even with the most strategic relationship, this level of partnership can be difficult to achieve and requires true commitment. “The additional time up front can make all the difference in the end,” explained Anderson.

Early in this process, the sponsor uncovered that one of the major impediments that CROs and sponsors face during study start-up is the use of multiple systems—a common challenge. Lack of a single source of truth makes it difficult to achieve business goals because real-time access to accurate data is not possible. Additionally, it’s not clear what version of a document is the most up to date.

“Having study start-up data on different systems, in different places is a big challenge,” explained the director of clinical operations for the sponsor company. “It causes redundant work, and creates training problems. If you think about employee turnover and the time for new hires to learn multiple platforms, it’s grossly inefficient. Having one, holistic platform for study start-up is a major improvement.”

A unified technology platform that allows for a seamless flow of data and content across all aspects of the clinical process, not just study start-up, will further help organizations work more efficiently.

Manage Change Together

Preparing teams for the inevitable changes associated with a new system and corresponding new workflows is paramount, and should start before implementation.

“Anytime you implement a new process, you run into change management issues. You need to communicate the steps your team will go through. Plan to explain why the change is taking place, what the benefits are, and the type of support or training they can expect. Assure your team they will have the support needed to be successful. You want the new processes to become a habit, not to have your team slip back into their old ways,” added Anderson.

Jointly Configure New Workflows and Processes

Once the sponsor and CRO agree on a study start-up platform, the companies will work to maximize its real-world value by co-configuring the system to establish efficient workflows that improve operations.

For example, the two companies are jointly configuring reports for routine progress updates and how they share key metrics and performance indicators. This allows the sponsor to receive real-time insight into its trials while the CRO gains the visibility it needs to proactively and effectively manage them. Historically, most vendors provide weekly updates for team meetings with their sponsors. By the time data would be aggregated and reports created, the results would often change, making it difficult to understand and react to issues proactively.

In addition to reporting, both companies are working to agree on accountability measures and joint workflows to reflect that within the system. This ensures the right team members will be held accountable for their relevant responsibilities in the start-up process. Creating workflows that automatically guide processes ensure there are no gaps, resulting in a seamless flow of data and content and timelines being maintained.

Configuring the solution together enables both parties to:

• Increase real-time data access, improving ability to make informed decisions
• Improve mutual accountability, reducing the historical fear of blame
• Lower the number of scenarios where one party is waiting for the other to review documents
• Improve ability to manage trials proactively  
• Reduce the burden of manual data entry and associated human errors

Capture Insights Together

Process automation and workflow improvements fall short if they do not deliver actionable insights and valuable metrics.

For many companies, the process of leveraging metrics or uncovering insights starts with a spreadsheet. Often someone sifts through the data in dozens of documents attempting to unearth useful information, making it easy to overlook a connection or miss an opportunity. This outdated approach doesn’t effectively support the complexity and pace of the current study start-up process.

In this new collaborative model, the sponsor and CRO are creating a study start-up environment where spreadsheets are not a necessity. Data is input directly into a single system, allowing both parties to review and respond to issues happening around the globe in real time. All data is immediately available to all team members, alerting them to potential delays and guiding any required changes in processes.

For most organizations, this real-time visibility is missing. A unified clinical platform that not only brings sponsors and CROs together but also connects study start-up across all aspects of clinical is crucial to ongoing, real-time visibility throughout the trial process.

“In a perfect world, there is a single system across all of clinical where data easily flows back and forth,” noted the sponsor’s director of clinical operations. “That would enable organizational learning across protocols and teams.”

Think and Act Globally

Across all geographies, the study start-up process is extremely intricate. Regulatory and ethics submissions differ in every single country, creating lots of replicated tasks for each market and opening the door for mistakes, process gaps, and delays. It’s crucial to identify and automate these redundant workflows so mistakes are minimized and resources used efficiently. By working together on a single platform, sponsor and CRO can reduce site activation cycle times regardless of location.

For example, if working in Belgium and a Central Ethics Committee submission is approaching but the sponsor doesn’t know the CRO is missing some required start-up documents, they would miss the submission deadline. The result can cause a huge downstream effect—most notably, a delayed trial.  However, if all teams are working on the same, global system with automated workflows in place, this type of issue would be easily identified and proactively communicated before it becomes a problem.

Looking Ahead In Study Start-up

Things are looking up, however–according to a the previously cited Tufts CSDD survey, CRO usage is one factor that positively correlates with faster cycle times. In this survey, CROs’ expertise equated to about a six-week time advantage in the full end-to-end cycle of a Phase 2 and Phase 3 study.

The opportunity still exists for significant improvements in study start-up. With complexity on the rise and the rate of innovation increasing, a new relationship between sponsors and CROs is taking shape. By working together as partners from the start of the trial to co-select and configure systems is proving one viable way to drive a more efficient path to success and innovation. When a system is configured with both partner and sponsor needs in mind from the outset, everyone is working in alignment and the CRO becomes an extension of the sponsor. Those notorious siloes come crumbling down, giving way to transparency, efficiency, and greater collaboration from the very start.

Ashley Davidson, director, Vault Study Startup, Veeva Systems Inc. is an industry veteran with experience encompassing all phases of research and therapeutic areas, including study start-up, regulatory affairs, proposal, and contract management. Davidson leads a cross-functional group that includes market owners, product management, marketing, services, and sales engineering with a primary focus on helping small and mid-sized customers meet their business needs. She can be reached at ashley.davidson@veeva.com.