The Turnkey Service for FDA SEND-compliant Submissions
SEND Express is your turnkey solution for Standard for Exchange of Nonclinical Data (SEND) dataset generation. Having worked with SEND datasets since 2005, our dedicated SEND Express Business Unit operates as an extension of your team, maximizing efficiency while maintaining high quality, speed and minimal impact on your internal resources. We aggregate and harmonize your data from multiple organizations, information systems and file formats to produce one submittable SEND dataset.
PDS' SEND Express has successfully prepared nearly 100 FDA SEND submissions in the past year and a half, with clients across three continents.
Your PDS SEND Express Solution:
- Eliminates your need to add headcount or software to meet the SEND requirements
- Is able to aggregate data from multiple sources, LIMS and formats
- Will meet your IND and NDA/BLA submission deadlines
- Guarantees that your SEND dataset will be accepted for review by the FDA from a SEND compliance perspective
- Creates Trial Domains, among the more difficult domains to create in SEND
- Compares the SEND datasets with the final study reports and ensures accuracy
Driven by expert preclinical scientists and data analysts, PDS' SEND Express team expedites data integration and harmonization by using TranSEND™, PDS’ proprietary software designed to generate submission-ready datasets. PDS creates proprietary adapters that electronically retrieve data from your study report and then map the data to the appropriate domains in accordance with the SEND standard.
Our experienced scientists will map the terminology utilized in your source data to the controlled terminology glossary required by the FDA. Data integrity is ensured with multiple GLP defined quality control steps followed as the dataset is generated. Your data is secure on our own U.S. based hosted servers and is never sent for processing overseas. Our team of preclinical scientists and compliance experts will partner with you to provide guidance throughout the package generation and submission processes. Send Express team members are active participants and committee leaders in CDISC and PhUSE - the two primary organizations driving SEND standards development and adoption.
SEND Express Deliverables
- Full set of SEND XPT files
- Define PDF and XML files
- QA and validation report
- Study Data Reviewer’s Guide
- QC documentation of SEND dataset review
Additional SEND Services
- SEND-readiness guidance: PDS can review your data files and advise you on best practices for assembling source data in SEND-ready format for efficient conversion to SEND datasets and compliance with FDA validation rules
- Assistance with development of a pre-IND Study Data Standardization Plan, part of a General Investigational Plan, per FDA recommendation, along with FDA representation
Get SEND-Compliant Packages With SEND Express
From assessment, to mapping and generation, to comprehensive submission guidance, PDS is your all-in-one FDA-compliant partner for SEND. For the flexibility and on-demand needs for submissions, choose SEND Express.
Contact the SEND experts to be SEND ready today.