Cleansing, mapping, programming and QC of in-scope nonclinical study data are all critical pieces of the regulatory submission process for both FDA Investigational New Drug (IND) Applications and New Drug Applications (NDAs). Certara’s expert biostats programmers provide submission ready CDISC SEND datasets and supporting documentation; these services are often utilized by biopharma companies without dedicated resources in this functional area.

Our team offers flexible delivery timelines for CDISC SEND dataset packages, as well as legacy SEND conversion projects to retroactively create SEND for older nonclinical studies that wasn’t required at the time the study was conducted but is now needed per FDA submission requirements. We can also support broader CDISC SEND conversion projects that integrate nonclinical study data into internal data warehousing environment.

What’s included as part of a SEND dataset services delivery?

QC of external SEND datasets

SEND dataset production and validation

Pinnacle 21 report creation and review

Nonclinical Study Data Reviewer’s Guide (nSDRG)

SEND define.xml

Trust our experts!

Having supported 300+ healthy authority submissions in the past 5 years, our teams are well versed in regulations and standardized data formats such as CDISC SEND, which is required by FDA when submitting data from nonclinical studies

Visualize nonclinical study data to inform key decisions

SEND dataset services are available in tandem with our propriety SEND Explorer software platform. Designed by scientists, SEND Explorer allows biopharma organizations to leverage their investment in SEND dataset creation by making study data and associated visualizations easily accessible to scientists to inform key decisions.

SEND Explorer is used by both FDA CDER and FDA CBER to visualize nonclinical data in regulatory submissions.

Scalable, integrated services in early drug development

In addition to SEND dataset delivery, Certara’s integrated early drug development services also includes toxicologists, DMPK scientists and pharmacologists to support pre-clinical study design and results interpretation.