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Regulatory Submission Reporting

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Get SEND-Ready with TranSEND™, Your Complete Submission Solution

 

TranSEND™ is the all-encompassing software solution to get your preclinical data SEND-ready. TranSEND effectively aggregates and translates data from multiple organizations and LIMS to produce one set of harmonized and validated SEND files, including define.xml and define.pdf, as required by the FDA.

In early 2014, PDS announced the release of the industry’s first FDA-validated, preclinical research SEND dataset made available to the public free of charge and qualification. The dataset can be used by scientists and research organizations across the industry to aid in validation and to serve as an example of a complete and FDA-compliant SEND dataset. The release of this anonymized dataset demonstrates our commitment to advancing electronic standards use and development in the noncompetitive space. The dataset is now available on the Pharmaceutical Users Software Exchange (PhUSE) website for use by the community.

Like all PDS solutions, TranSEND was built by a team of expert programmers and scientists. TranSEND is more than a necessary piece of software — it’s a flexible and easy-to-use tool that simplifies the SEND translation process. For example, TranSEND allows the use of multiple glossaries, each of which is mapped to required controlled terminology. Once initial mapping is done, versioning is simple as new controlled terminologies become available because of TranSEND’s unique self-learning technology. And when you choose TranSEND, we make sure it works to accelerate preparation of your submission package. Our team of toxicologists and IT personnel will partner with you to provide guidance that will smooth your transition to being SEND-ready.

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TranSEND™ At-a-Glance

Features

  • Web-based and easy-to-use graphical interface
  • Stand-alone solution — can be used with different data sources (with adapters)
  • Tracks all previous downloads and submissions for a given study or studies
  • Enables you to submit SEND files based on a scheduled batch processing you define using a Windows command line
  • Independent life cycle from other PDS products: There’s no need to revalidate other PDS products when TranSEND is added
  • Enables you to use what works best for you by choosing between command line or graphical user interfaces
  • Uses the OpenCDISC validator enhanced with additional FDA validation rules to validate all outputs against SEND standards
  • Every domain and variable in the SEND Implementation Guide 3.0 (latest version) represented

Additional SEND Services

  • Initial terminology mapping: We can ensure TranSEND speaks the language your LIMS does by applying more than 3,000 terms in the Controlled Terminology lexicon
  • SEND-readiness guidance: PDS can review your data files and advise you on best practices for assembling source data in SEND-ready form for efficient input into TranSEND and compliance with FDA and CDISC validation rules
  • SEND as a service: We can create a SEND-compliant dataset ready for FDA submission
  • Development of LIMS-specific adapters
  • Compilation of a SEND Reviewer’s Guide, considered by the FDA to be an “integral part of a standards-compliant study data submission”
  • 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-Ready with TranSEND

From assessment, to implementation, to comprehensive submission guidance, PDS is your all-in-one FDA-compliant partner for SEND. For the flexibility and control scientists need to work like they think, get the complete submission solution — TranSEND.

 

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