As a leading global provider of software and solutions for preclinical research and development companies, PDS stays informed with SEND standards, best practices and FDA expectations by being highly involved in the SEND community. PDS is a member of both PhUSE and CDISC.
The PDS team has developed the industry’s most comprehensive line of intuitive software and services to help get your team SEND-ready. PDS offers 2 options:
What Is SEND Express?
PDS’ SEND Express™ business unit offers a highly cost-effective service for companies looking to outsource the creation of their SEND datasets. SEND Express streamlines and simplifies your SEND dataset creation process by providing a turnkey service supported by a team of preclinical experts and data managers dedicated to SEND.
- Our US-based SEND Express™ business unit operates as an extension of your team
- Maximizes efficiency while maintaining high quality and speed without impact on your internal resources
- Aggregates and harmonizes your data from multiple information systems and file formats to produce a SEND dataset that is ready for submission
- All work is done in the US within a GLP-compliant data center
- Your IND or NDA SEND submission is guaranteed to be FDA compliant
What Is TranSEND?
TranSEND is a flexible, all-encompassing and easy-to-use software solution that facilitates the process of translating preclinical data from its source to SEND format.
- Effectively aggregates and translates data from multiple organizations and LIMS
- Produces one harmonized SEND dataset, including define.xml and define.pdf, the Study Data Reviewer’s Guide (SDRG) and the validation report as required by the FDA
- Available as either a hosted system (SaaS) or installed in your IT environment
The SEND Submission Process With PDS