Standard for the Exchange of Nonclinical Data

The Standard for the Exchange of Nonclinical Data (SEND) implements the Study Data Tabulation Model for nonclinical studies, facilitating the modernization and streamlining of the review process by the U.S. Food and Drug Administration (FDA). Compliance with SEND is crucial for FDA data submission, guaranteeing data consistency and expediting regulatory procedures.

One of the significant advantages of SEND is its endorsement by the FDA for submitting electronic data related to nonclinical studies. This endorsement highlights its credibility and reliability in the regulatory landscape. By adopting SEND, stakeholders can streamline the submission process, enhance data quality, and facilitate regulatory review.

Global Pharma Tek understands the critical importance of standardized and compliant data submission in the realm of nonclinical studies. Thats why we're proud to offer our specialized SEND (Standard for the Exchange of Nonclinical Data) services tailored to meet the unique needs of our clients in the pharmaceutical industry.

With our SEND services, we aim to streamline the process of data submission while ensuring adherence to the stringent regulatory standards set forth by the FDA. Our team of experts is dedicated to providing comprehensive support at every step of the way, from data collection and transformation to final submission.

By leveraging the latest technologies and adhering to industry best practices, we help our clients achieve greater efficiency, accuracy, and compliance in their nonclinical data submission efforts. Whether you're a pharmaceutical company, contract research organization (CRO), or regulatory agency, you can trust Global Pharma Tek to deliver reliable and high-quality SEND services tailored to your specific needs. To ensure your nonclinical data is successfully accepted

We provide:

SAS® Transport
Files (XPT format)

Define File
(XPT format)

Study Data Reviewers
Guide [nSDRG]
(DOC format)

Additional SEND services include:

Dataset generation
in multiple formats
(XPT, XML, and XLSX)

Create Data
Definition Define
file version 2.0

Validation and
quality control

Interim datasets

dataset merged from
multiple sources and
data types

Specific domains or
whole studies for
warehouse applications
and legacy studies

Experience the difference with Global Pharma Tek's Nonclinical SEND Services. Contact us today to learn more about how we can support your data submission needs and help you achieve your regulatory goals.

Contact Us
Scroll to Top