Smartsheet dashboards and sheets give Karyopharm's clinical teams, CRO staff, and project managers constant access to trial information.
The scientists, lab technicians, and project managers at Karyopharm Therapeutics Inc. have an ambitious goal: to create drugs to more effectively treat cancer, autoimmune disorders, and other major diseases. Making a big difference in the lives of patients means carefully managing the smallest details — everything from efficiently setting up and certifying a clinical trial to updating records when a researcher’s office gets a new phone number.
“We have active studies that encompass over 350 different centers such as hospitals, small clinics, and medical schools across more than 20 countries,” says Oscar Gonzalez, program planning manager at Karyopharm. “A lot of organization has to happen to achieve our goals, and it’s truly a labor of love. The people here have a passion for what they’re doing and for what, ultimately, we’re trying to do for patients.”
Headquartered in Newton, Mass., Karyopharm is focused on the discovery, development, and commercialization of novel drugs that regulate the movement of proteins within cells to help them destroy cancer cells, without the same toxic side effects that previous compounds targeting these cellular proteins have shown. Gonzalez is responsible for identifying and managing risk for the company’s clinical trials, which help researchers determine whether the drug has the same effectiveness and safety profile when given to patients as it has exhibited in laboratory testing.
Conducting clinical trials requires careful design, formal approval of testing by the appropriate national regulatory agency such as the Food and Drug Administration (FDA) in the U.S., training and certification at each clinical site where trials will be conducted, and scrupulous tracking of the trial’s progress — including any unexpected events. Delays at any point in the process can ultimately delay the drug’s review and approval for commercial availability. Gonzalez tracks information and updates from several Karyopharm departments as well as from hundreds of trial sites, including the contract research organizations (CRO) that manage programs in the countries where Karyopharm doesn’t have staff on the ground.
“A lot of these projects can exceed two or three years,” Gonzalez says. “You have to maintain a constant relationship and constant engagement, and that also includes feeding information back and forth from our medical affairs group and our medical clinical research administrators, so we can better adjust our projections or our end goal.”
When Gonzalez joined Karyopharm, much of this information management was done with spreadsheets sent back and forth via email, leaving staff or clinical teams with conflicting or outdated information. Karyopharm considered adopting a widely used project management system, but the vast number of people who needed access to review or input data made licensing for the solution prohibitively expensive. Smartsheet provided a central location for project information with the flexible, secure access required to manage medical data from around the world.
With Smartsheet, Gonzalez can create sheets with information about each clinical trial, and grant access to CRO staff or clinical teams so they can provide their own real-time updates such as site readiness, patient enrollment, progress toward deadlines, or side effects or health issues that patients may experience during the course of a trial. He has also created dashboards to aggregate data from different sheets, so that he and the project managers for specific trials can instantly see vital status updates such as whether a site has met its enrollment target or is running short of supplies such as lab kits.
“This dashboard has become the icon of what our projects are doing,” Gonzalez says. “It allows everyone within the company to see how their work is affecting the bottom line, which is when can we finish the project — because ultimately, we need to get this medication to patients.”
The dashboards have proved so popular with Karyopharm stakeholders that a project is underway to set up screens that can live-stream them to staff throughout the company’s headquarters — as Gonzalez puts it, comparable to a Bloomberg terminal for Karyopharm’s drug development process. It’s an innovative way to keep everyone informed, which is not just a smart communication strategy but a matter of regulatory adherence as well.
“This is a pharmaceutical company. We’re subject to inspections at any time,” Gonzalez says. “It’s important for everyone to have an idea of what’s happening across the board, not just within their immediate role. That information gets discussed within development leadership meetings every week — where I actually use Smartsheet a lot.”
One of the biggest advantages Gonzalez sees with Smartsheet is that it keeps important updates out of Karyopharm staff email inboxes. In an industry where it’s not uncommon for an individual staff member to have thousands of unopened emails at any given moment, having a more direct way to deliver information saves time and effort for everyone. It also helps ensure that the company can be aware of upcoming deadlines; for example, when the last patient at a clinical site has taken the last dose of an investigational drug, the clock starts ticking on deadlines for reporting trial data to regulatory bodies. And it makes it easier to confirm that all necessary documentation has been collected and verified before it’s time to submit the drug for commercial approval.
Gonzalez has not only created a valuable information resource for Karyopharm, he’s created a name for himself within the company by solving one of the biggest problems they were facing. Having proved the value of Smartsheet to the clinical operations teams, he’s eager to help other teams adopt the solution and streamline their own processes.
“When you understand the system you can do almost anything,” Gonzalez says. “It can pull out metrics or information that you thought was only available by data mining. It not only allows me to visualize the entire program, but it gave me a purpose and a platform to optimize this company’s functionality in a way that I never thought was possible. I would never have thought I could have this type of impact in a company; Smartsheet essentially led the way for me to do that.”
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Source: Smartsheet Blog
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