This spring, Megan Bausman and Mikayla Simons will lead a Covance-hosted session at the Society of Toxicology on how to visualize the Standard for Exchange of Nonclinical Data (SEND) to gain more insights into your data and to preview what’s coming in the release of SEND 3.1
SEND is the electronic, standardized format for submitting preclinical toxicology and carcinogenicity data to the FDA. SEND datasets make complying with regulatory submission requirements easy; however, the raw SEND datasets, though rich in information, are not easily readable to clients without the aid of data visualization software. Covance has been a proactive partner in the development of SEND: since 2016 we’ve delivered over 125 billion data points to hundreds of clients. Browse our SEND education center.
Our Covance-led session at the Society of Toxicology conference in March will explore insights we’ve gained from using data visualization tools on SEND datasets, and the benefits these tools can bring to you.
We will also draw upon our extensive experience to survey the evolving regulatory landscape, looking ahead to the release of SEND 3.1 and its impact on nonclinical Safety Pharmacology studies.
Megan Bausman – Global Data Management Solutions Lead. With 20 years of experience in nonclinical reporting, Megan is an advocate for innovation and automation in the generation, reporting, and use of the billions of endpoints resulting from nonclinical studies. She has implemented the SEND standard for the global safety assessment business at Covance and is based in Madison, Wisconsin. Megan has previously participated in the CDISC SEND Consortium and PhUSE working group 6 for historical control data. She was the recipient of the Early Development annual award as “Madison Innovator of the Year” in 2014, the Covance Way Award in 2015, and the Covance Alliance Partnering Excellence Award in 2017.
Mikayla Simons – Nonclinical Data Associate. Mikayla has worked in the Covance SEND team for the past 3 years. She primarily generates and prepares SEND datasets, however she is also spearheading efforts for preclinical data visualization for Covance’s study direction teams. Mikayla began her career as an intern at Covance, working with a preclinical historical control database and has since been able to step into the greater pharma community thanks to SEND.