As clinical trials become increasingly complex, biotech and pharmaceutical companies rely more heavily on contract research organizations (CROs). In fact, CROs are predicted to perform nearly three-fourths of clinical trials by 2020.¹ With so many of the world’s new drug trials now a combined effort, efficiency and open collaboration between CROs and sponsors is critical.

Given this reality, many CROs are re-examining their operations and reporting the need to unify clinical applications to achieve new levels of efficiency and collaboration. Most life sciences companies employ an average of four different applications to manage clinical studies today, and more than one-third use at least five, according to a recent industry survey of 300 clinical operations professionals.²

These disconnected legacy applications and manual, spreadsheet-driven processes are no longer sufficient, hindering visibility for sponsors and internal teams, and slowing trial execution. It’s why CROs are taking significant steps to modernize their environments, with more than 60% reporting faster study execution and improved study quality as the top drivers toward a unified clinical model.²

One full-service CRO recognized early the importance of adopting a unified model for seamless collaboration with sponsors. It was growing rapidly, as demand for its therapeutic expertise spread. The increasing complexity of managing more studies in more locations globally prompted the company to make a major change. The CRO’s vision was to replace its various systems and manual processes with a suite of connected applications to more efficiently manage end-to-end trial processes, improve inspection readiness, and increase visibility with sponsors for improved study quality.

“Our current systems and processes couldn’t scale with our growth or the changes we had to manage in clinical trial operations,” said a company spokesperson. “We needed to bring processes and systems and people together to increase operational efficiency and visibility across global studies.”

The path to a unified clinical operating model
The CRO transitioned from managing trial documentation manually through paper, email, and scanners to a suite of clinical applications from Veeva Systems that brings together electronic master file (eTMF), study start-up, and their clinical trial management system (CTMS) onto one cloud platform.

The CRO streamlined cross-functional activities and improved both internal and external collaboration. For example, its teams now create site monitoring reports or CVs directly in the CTMS or study startup system, which automatically become part of the eTMF. Time-consuming, manual steps are eliminated, and cross-functional teams, including sponsors, can leverage current information.

By bringing these systems together in the cloud, this specialty CRO made it easier for teams to manage all information and trial processes from site activation to study closeout. Internal teams and sponsors have complete visibility into how the trial is progressing, such as the health of the TMF, planned site activations, and enrollment statistics. Study teams work from the most current information updated in real-time, enabling more proactive decision-making throughout the entire lifecycle of studies.

Here’s a closer look at the company’s blueprint for shifting to a unified clinical operating model.

Enabling real-time inspection readiness
The CRO began its transition to a unified environment by replacing its paper-based trial master file with an electronic trial master file (eTMF)—Veeva Vault eTMF. Implemented in less than eight weeks, the application enables active TMF management so the company can manage documents in real-time as the TMF is generated and ensure completeness for a constant state of inspection readiness.

The team increased productivity and process efficiency by replacing manual tasks with automated version control and tracking. Internal and external stakeholders now work in one system. New capabilities also support remote audit, inspection, and monitoring. And, comprehensive reports and dashboards provide insights into TMF status so project managers can more easily identify and sort out issues throughout the trial—rather than later, when it may be more difficult to resolve.

With this new approach, the CRO no longer wastes time configuring a paper TMF, dramatically reducing study close out time—from weeks to just days. The solution also provides internal stakeholders and sponsors with real-time visibility into content from trial setup through to archival status for better collaboration and decision-making all along the way.
Similarly, global CRO Exom Group deployed the same system to streamline trial processes and improve collaboration with investigator sites and sponsors. After deploying the solution at 50 clinical sites across two studies, Exom realized between 30% and 40% efficiency gains in document management. Exom clients now have direct access to clinical trial documentation through the cloud system.

“Innovation hinges on how efficiently organizations like ours collaborate with clinical trial investigators and sponsor companies,” said Luigi Visani, chief executive officer, Exom. “It is critical that we can interact efficiently so clinical trials are conducted at a fast pace and medicines get to patients as soon as possible. With an integrated, single source of data, we streamline the clinical trial process and drive efficiency.”

Speeding study start-up activities
The CRO’s next step was to add a study startup system to accelerate global site identification, feasibility, selection, and activation.
Veeva Vault Study Startup includes built-in country intelligence and workflows that automatically generate a list of essential documents and activities required to activate a site, a function that now happens more quickly. The CRO automatically tracks study start-up documents, including protocols, CTAs, and budgets and teams create site monitoring reports or CVs in the system to provide ongoing updates to sponsors.

Since Vault Study Startup and Vault eTMF are on the same cloud platform, the CRO eliminates duplicate data entry and established a reliable audit trail to immediately identify the source of all start-up related content and data. “We’ve improved productivity and can quickly spot the source of delays, such as why the clinical trial agreement isn’t complete, to keep the program on course,” added the spokesperson.

Improving visibility across multiple trials
Most recently, the CRO adopted Veeva Vault CTMS to empower its clinical teams with greater insights across the trial lifecycle. With this new application serving as the single source for all clinical trial data and information, the CRO gained a global view across clinical trial tasks and processes. Data collection is streamlined and all stakeholders can see what everyone is doing, and when. 

Vault CTMS provides interactive dashboards that make it easy for teams to know program status and take immediate action to complete next steps. “We are doing true project management without spreadsheets, and that is a big improvement,” said a spokesperson. “Instead of manually compiling information in multiple spreadsheets, project managers have real-time access to study data so they can make better, more informed decisions.“

The CRO accelerated study execution and gained end-to-end visibility across global studies. “Using Veeva Vault CTMS was a natural next step as it worked on the same platform as the other applications with the same user-friendly feel to reduce the learning curve.  We have completed the last leg of our journey to unify clinical operations, and with positive results,” the spokesperson added.

Close-out: Improved study execution and quality for sponsors
Since moving to a unified clinical environment, the specialty CRO has increased the speed and quality of running global clinical trials. Study close-out time is now just days instead of weeks. Processes are streamlined with end-to-end visibility, and all stakeholders work from a single source of documents and data—all critical to working in the ever-more complicated clinical trial landscape. In addition, both the CRO and its sponsors can capture real-time metrics across multiple studies.

Unifying clinical operations can have a positive impact that extends beyond clinical to the entire organization including regulatory operations. Specifically, companies can reduce the number of steps in the processes of creating a protocol, collecting essential documents, supporting the submission, and finalizing the clinical study report. With all stakeholders working on the same platform, companies can also significantly reduce the tedious back-and-forth, logging in and out of different systems, and downloading and uploading the same documents multiple times from multiple places. When systems are unified, information automatically flows between them seamlessly.

Now this growing CRO collaborates more easily with sponsors and provides real-time access to trial information—a key advantage in building long-term, strategic relationships with sponsors. Most importantly, the CRO runs trials more efficiently to help bring new products to market faster for its customers and in compliance with global regulations.

One potential challenge in adopting a unified approach to enabling technologies in clinical operations is the fact that some mature CROs have investments in technologies already, and have done considerable operational design around those technologies. An investment in neutral process/organizational design can help CROs realize the advantages of this approach, according to Waife & Associates, Inc., an independent clinical research IT consultant. 

“Companies must determine organizational preparedness, which means understanding one’s own capabilities and anticipating the impact of software or process change before it is determined, purchased, piloted, or implemented,” said Ronald Waife, president, Waife & Associates.

For any company considering this path, determining organizational readiness is critical to success. Be sure to assess the internal appetite for change early and educate the team. The ability and willingness to embrace a new model gets considerably easier once pilot users experience the impact of a unified environment on their daily jobs and understand how it will benefit the entire organization. 

References

1. Research and Markets, “The New 2015 Trends of Global Clinical Development Outsourcing Market.”
2. Veeva 2017 Unified Clinical Operations Survey, by Veeva Systems, September 2017. For more:  http://go.veeva.com/2017-unified-clinical-operations-report.

---

Jim Reilly is vice president of Clinical Market Strategy at Veeva Systems, where he is responsible for defining the market approach for the Vault Clinical suite of products. He can be reached at james.reilly@veeva.com