When it comes to central lab responsibilities, project managers subscribe to two famous adages: “Anything that can happen, will happen,” and “An ounce of prevention is worth a pound of cure.”
What that means is project managers need to take a proactive approach, being prepared for any complications that may arise along the clinical trial pipeline, said Chris Clendening, executive director of project management and design for PPD® Laboratories’ central lab.
“The central lab industry has a large number of moving parts — testing samples, chain of custody, logistics, budgetary concerns — that have to be monitored on a daily basis.” The challenge for central labs is to be able to know which operations are on track and which aren’t, make adjustments “on the fly” and communicate changes to the client in a timely manner, he said.
PPD® Laboratories’ new project management (PM) dashboard offers a graphical overview of the clinical trial’s progress based on information from the Preclarus® central lab database. The dashboard provides context for decisions, keeping studies on track operationally and helping the project team manage the study budget, Clendening said.
The PM dashboard provides a data visualization tool with powerful tracking and trending capabilities. Project managers can quickly assess the status of each of their trials using study data, metrics and performance scorecards that the PM dashboard has consolidated and arranged. The tool highlights areas of risk and unfavorable trends so project teams can focus on areas needing the most attention.
According to Carolyn Maki, executive director of the PPD Laboratories central lab business development team, the dashboard provides clinical trial sponsors with an easily accessible and aggregated visualization of customized data that will help them make more confident decisions earlier in the process. “Project managers can look at the risks or unfavorable trends and key project metrics to take a proactive approach to study management.”
Cutting the cost and time of drug development
A complex drug testing industry demands new medicines be brought to market faster with accurate, quality data to drive key decisions and keep costs in control, said Hacene Mekerri, vice president of operations for PPD Laboratories’ central lab.
Clinical trial investigators don’t want to get to the end of their trial before learning data corrections are needed. The dashboard helps clean the data, shortening the time it takes for drug companies to get to a database lock, which is a key milestone for clinical trials, Mekerri said.
PPD’s central lab team recently trained project managers to use the dashboard, and visualizations will be shared with clinical teams on a monthly basis, Clendening said.
Compared to other trial management tracking tools, PPD Laboratories’ PM dashboard is more accurate because it comes from a single global database with real-time, study wide data that can be personalized down to the site level as needed, he said. With the dashboard, trial sponsors know as much as the project manager about the status of the clinical trial at any point in time. “They should know what the costs are and what the challenges are, so it takes out any ambiguity,” Clendening noted.
Proactive response to resolve issues
The PM dashboard helps PPD central lab project managers like Emily Long give test sponsors information about exceptions, queries and sample management items. Further details might include whether the kits expired, test summaries, the number of tests cancelled and the percent of cancellations compared to completed tests, said Long.
Using the dashboard, project managers can help resolve issues at the site level more proactively, rather than waiting for a “fire” and trying to put it out.
The dashboard also makes the project manager’s work more efficient. Instead of having to pull information from multiple data sources, the PM dashboard organizes all the data into one easily accessible visual, she said.
“It can be tedious and time consuming to comb through all of these reports [from multiple sources and systems] to get a true picture of the health of a trial,” said David Stein, an independent eClinical consultant. “On the other hand, when a project manager has access to a dashboard that sits on top of real-time, aggregated data from these sources, it is much easier to identify issues and to drill down into the areas needing attention,” he said.
“For example, if the dashboard shows that the central lab has not received samples from some sites, with a few mouse clicks, the project manager can identify which sites have the issue and can then drill into more detailed records to see when the samples were collected and sent,” Stein continued. “They can also cross-check with other records to verify that a patient visit occurred on that day, that the visit required lab samples and so on.”
While dashboards may be new to central labs, they have been used successfully in many other business applications, Clendening said. When designing its new PM dashboard, PPD studied what worked in other industries, such as information technology, manufacturing and e-commerce. Website designers and developers, for instance, may use a dashboard to learn about human behaviors and determine which of their websites receive the most traffic. They also can use the data to make their websites more productive and effective, Clendening said.
The key to PPD’s PM dashboard is that it helps project managers be more organized and proactive by allowing them to consult a consolidated database rather than reactively pulling ad hoc reports from multiple systems. The bottom line is that this dashboard will give managers better access to data and more confidence in their decisions. The PM dashboard will be the standard approach for delivering project metrics and associated context for all of PPD Laboratories’ central lab studies at no additional cost to clients.