In 2016, the Food and Drug Administration (FDA) made the move to digitization by requiring the collection and submission of datasets for nonclinical studies to be filed electronically in a standardized, consistent format. Known as the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data (SEND), this format is now the digital standard for submission-ready datasets for general toxicology, carcinogenicity, safety pharmacology, legacy and any relevant non-GLP studies.
When the original FDA provision came through, we made sure you were ready. We have long been involved with the SEND consortium as well as the FDA and Pharmaceutical Users Software Exchange (PhUSE) working groups that develop and maintain the standards guides for the industry. This enabled us to build our SEND infrastructure years before 2016. We built it with a clear vision to maximize the utility of your study datasets by ensuring your studies were compliant to the new regulation and you were set up right to leverage the power of your data in new and innovative ways. Today, our customers have received over 125 billion data points and more than 1,500 SEND data deliveries each year.
Now, as we grow our global footprint, we are elevating you to the next generation of SEND capabilities at every site. This way, you have access to all of the benefits of SEND regardless of which of our nonclinical facilities is conducting your study. We have already activated the latest version—SEND 3.1—at all eight of our nonclinical safety assessment sites worldwide. “In SEND 3.1, you can expect everything previous versions of SEND delivered, now at hyper-speed, reducing turnaround time for a submission-ready SEND dataset from the typical 12 business days to only one. That speed and power is the new standard for all of our nonclinical studies and sites,” says Megan Bausman, Director, Global Data Management Solutions.
“In SEND 3.1, you can expect everything previous versions of SEND delivered, now at hyper-speed, reducing turnaround time for a submission-ready SEND dataset from the typical 12 business days to only one. That speed and power is the new standard for all of our nonclinical studies and sites.”
– Megan Bausman, Director, Global Data Management Solutions
But we didn’t stop there. You told us you want even more of your study data presented in the SEND format. Our SEND service expansion includes two additional services, automated data delivery and data conversion. “Why limit the power of the SEND standard to studies started since 2016? Or only to in-scope studies for the regulatory requirement?” asks Bausman. “With our newer SEND service offerings, you have more options available to take advantage of the SEND model.”
Automated data delivery is our innovative solution for providing you with near instant access to your in-progress study data. It enables you to monitor your ongoing studies and swiftly make decisions during time-sensitive points of your study—such as the in-life phase—when making smart decisions early can save you time and money in your development program.
Lisa Biegel, Vice President and Global Lead, Safety Assessment Study Direction, Reporting and Data Management, illustrates how automated data delivery can play a critical role in the development of your studies. “SEND helps our clients make smarter decisions. For example, early study indications can sometimes uncover something unexpected that may lead to a key strategic decision in a drug’s development. You don’t want to wait three months for the conclusion of the study and final report when you can get the data on day four of a study. When you can see the data, you can make those important decisions faster.”
Another benefit of SEND is its power to easily interrogate and visualize an extensive collection of data. This SEND feature is called data conversion. By looking at your broader library of studies, SEND can give you valuable insight regarding your asset portfolio to set a more informed strategy going forward. “It’s not only about looking at a single study. It’s about looking across all of your studies to see what is there. What stories does your collective of data tell you? You can look at studies within a program, across a species or creatively at any combination of the fields in the SEND dataset. You can go back in time and convert the study data of your historical studies as well. Ultimately, you can utilize this goldmine of data and gain value from it that you may not have realized was there,” explains Jason Pitzer, North American Regional Manager of Data Management.
“It’s not only about looking at a single study. It’s about looking across all of your studies to see what is there. What stories does your collective of data tell you? Ultimately, you can utilize this goldmine of data and gain value from it that you may not have realized was there.”
– Jason Pitzer, North American Regional Manager of Data Management
Our mission is to continually push to break the mold of what digitization can do, which will further strengthen and facilitate a frictionless development pipeline for you.