Celerion accelerates clinical research
Celerion provides comprehensive, early clinical research and bioanalytical services to sponsors of drug development projects. The name Celerion, derived from the Latin “celeritas,” means swiftness and speed and reflects one of the company’s founding principles: to deliver services that enable clients to get products to market faster.
Celerion supports its core principle by using SAS® Drug Development to assist clients in making timely and informed, go or no-go decisions on compounds. The software allows users to access compliant, submission-ready research data – faster and seamlessly.
"With the SAS Drug Development platform, we have improved data integrity and traceability," says Michelle Combs, Vice President of Clinical Pharmacology Sciences at Celerion. "By having seamless integration, consistency of data and a standardized approach, we can pull in data from multiple systems, like our clinical data acquisition system, all within a secure and consistent, centralized repository. For clients that also have SAS Drug Development, we can deliver data in real time, instead of days or weeks, in an environment that is in full compliance with 21 CFR Part 11.
"Celerion works with clients to get their products to market as quickly as possible so that they can treat disease and save lives. In order to do this, it is critical to make scientifically sound decisions on an ongoing basis, so having quality data delivered quickly is essential to our clients. Since speed is such a critical element of the work we do, it is imperative that we work as efficiently as possible. Our goal has been to invest in different technologies and innovation to help us perform more efficiently and meet our clients' needs."
Our use of SAS Drug Development aligns well with our mission and our goals for innovation. It makes us more competitive, allows us to offer better solutions and achieves our end goal of helping our clients get their drugs to market faster.
Celerion is using SAS Drug Development in an on-demand environment hosted by SAS, enabling the efficient development, execution and management of analysis and reporting activities for its clinical research. And for clients that also use SAS Drug Development in their organizations, Celerion can offer fast, real-time access to data at any stage of the development process.
"Clients accessing the system are the people who are making the decisions on their studies; it allows them to access the data after it's been collected to determine what is happening, " says Tamara Cuddy, Associate Director of Biostatistics and Data Programming at Celerion. "Before, if clients requested data, they would have to call and ask us to deliver it. Now, the SAS solution allows for an automated process to deliver the data to them on a regular basis.
"They have the access and ability to see what's happened. If there are a significant number of adverse events in the study, they can see it right away and they can make a decision regarding participant safety. They can decide whether they need to stop and focus on another study at a given point. Additionally, in the past, for any interim analysis that we might have been spending time on, we would have had to stop every week and go through a similar sequence of events to give them the data that they needed. Now we don't have to; they have it at their fingertips."
"When a client has SAS Drug Development, the process becomes a direct transfer from system to system," adds Karl Miller, Senior Data Analyst at Celerion. "One of the benefits with both parties being on the SAS platform is direct write access; the equivalent of us writing directly to their system. It really speeds up efficiency."
Echoing Cuddy and Miller, Combs says, "Clients can access data four to six weeks faster, which saves them time and allows them to be more adaptive in their strategic decision making."
Furthermore, Cuddy adds, "Our investigators, in charge of participant safety in the clinical conduct, have access. It allows them to not only view the data, but sort the data differently; to use the tools to probe data in a way that they were unable to before."
"It is important to deliver data to all clients in the way they want to see it," says Stephen Read, Manager of Data Programming at Celerion. "With the SAS OnDemand solution, we don't have to pull data out of controlled environments for clients. For example, using the old method, when we build a data transfer it has to be pulled off our server and sent through a password-protected e-mail. Now we have capabilities that can push the data directly onto a client system, and the compliance isn't lost in that final transition; it's going from one controlled environment to another. Whereas, arguably, once we start pulling data outside of the system we risk losing that level of security. And that's why we're looking to further leverage SAS Drug Development with all of our customers – to have that added compliance and traceability."
According to Read, the SAS platform provides more flexibility for a variety of users. "We have started to leverage SAS Drug Development to enable non-programmers to work through pro forma procedures. For example, we now have an auto-coding initiative, whereby in our previous environment programmers would have to set up programs that would code to adverse events, medical histories and concomitant medications. We are using the tools to enable data managers, who are not trained in SAS programming, to go in and run those procedures and work on coding without the need to know any SAS syntax."
Another benefit Celerion has derived from SAS Drug Development is its ability to access and combine data from multiple sources and systems, providing a global, integrated, consistent and compliant platform that all SAS users in the organization can access.
"SAS Drug Development has enabled us to implement CDISC standards, so now we have clearer, straightforward and robust processes and procedures in place; they're more transparent, traceable and refined," continues Read. "We have moved into the realm of cloud computing, and it has future-proofed our business. We can have programmers logging in to our fully regulated environment from anywhere in the world, at any time."
"From a statistics standpoint, there's really no question in my mind what you would use to analyze data," adds Cuddy. "It's just flat-out going to be SAS. It's a stable system; it's a system that can do any type of analysis that we need to do."
"Our use of SAS Drug Development aligns well with our mission and our goals for innovation," says Combs. "It makes us more competitive, allows us to offer better solutions and achieves our end goal of helping our clients get their drugs to market faster."
Celerion required a global, integrated and compliant clinical research platform to assist clients in making timely and informed, go or no-go decisions on compounds by allowing them to access submission-ready research data – faster and seamlessly.
- A secure, consistent centralized repository for submission-ready data that's auditable and in full compliance with 21 CFR Part 11.
- Efficient and secure delivery of clinical research data in real time versus weeks.
- Pro forma procedures can be run by users who are not trained in SAS programming.
- A fully regulated environment that users anywhere in the world can access at any time.
- Investigators can view, sort and probe the data in new ways.