There’s no denying that studies are only as strong as their resulting data—and nonclinical studies produce a lot of data. A two-week study can easily generate more than 2 million results, while a two-year study can contain upward of 500 million data points. In an effort to process and easily interpret these massive data files, the FDA has developed SEND (Standard for Exchange of Nonclinical Data).
While it’s easy to think of SEND as another obstacle, it’s actually an opportunity to reveal new insights and gain efficiencies in data management. Exchanging information in a standard format can ease knowledge transfer between internal and external databases, as well as provide a common framework to support a more robust submission process. Coupled with the emergence of new tools for visualization and statistical analyses, SEND has the power to revolutionize the way data drive drug development decision making.
A growing demand
We’ve witnessed a growing demand to implement SEND proactively, well before the FDA requirements take full effect. Based on the initial FDA guidance released in December 2014, we’re expecting interest to rapidly increase as the additional specifications are released in the next several months.
Getting on board with SEND is fairly straightforward. A team of specialists skilled in data coordination and software systems, along with subject matter experts in safety assessment science, convene to determine approaches for internally and externally generated data. Existing or expected datasets will be reviewed at a pharmaceutical company and prioritized among compounds.
With this background, a SEND production team categorizes the data into distinct domains to create one dataset for each study, then applies controlled terminology and packages the nonclinical data endpoints along with the final study report, adhering to the standards of the latest FDA guidance, called SENDIG 3.0.
Once data files are SEND compliant, it’s much easier to interpret results and dig deeper into the data to locate trends or uncover anomalies, especially across expansive datasets. Data standardization also eases management in data warehouses and contributes to a growing collection of more accessible and uniform historical control data.
Easing into SEND
Initially, SEND compliance, which will go into effect in December 2016 for NDA required studies, only applies to general toxicology and carcinogenicity studies. Over time, it will expand to more study service areas, such as safety pharmacology (cardiovascular, respiratory) and DART (EFD).
Now it’s no longer a question of if you need to be SEND compliant, but when? Given the imminent deadlines in the coming years, we’re keeping one step ahead of the developments to not only meet FDA compliance but also reveal new opportunities today for you – our clients.
As an active participant of the SEND consortium since 2002, we’ve worked with other pharmaceutical and software leaders to create guidelines that best manage and exploit this explosion of digital data. And while we’ve helped define the requirements, we’ve also incorporated best practices into our own processes, delivering hundreds of SEND studies and literally billions of data points during the last few years.
If you’re ready for more insightful data to drive your drug development program, get in touch with us to see how your results can be transformed with SEND.