SEND Services

Ensure submission ready SEND datasets from any data source

Digital Services

Overview

In life sciences, submitting data to regulatory bodies in a standard format is fundamental for the data-intensive nature of the pre-clinical research process. Throughout the pre-clinical development lifecycle, sponsors and CROs may find themselves with insufficient resources to execute the time consuming process of collecting and presenting non-clinical data in a consistent format that meets SEND standards.

Atos Syntel is focused on meeting future Life Sciences industry requirements, with the right solutions, resources and experience to provide seamless data standardization — especially in the pre-clinical domain. As an industry leader in this area, we have helped our customers set-up global, scalable data standard processes with guaranteed quality to support their pre-clinical FDA submissions.

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Offerings

Atos Syntel is an industry leader in data standardization , with deep experience in pre-clinical studies for the life sciences industry. In addition to supporting the FDA’s SEND standards, we also closely monitor steps taken by the European Medicines Agency (EMA) as well as Japan's Pharmaceuticals and Medical Devices Agency (PMDA).

We are committed to providing our clients a successful and risk-free SEND program, with strategic technology investments, deep expertise and process capabilities — all backed by competitive pricing models. Our services include:

Consulting Services

  • Support and guidance to meet the challenges of SEND compliance

Legacy Data Transformation

  • Conversion to SEND-compliant formats
  • Standardize SEND datasets and study reports as per FDA standards
  • Identify errors and validate data using Pinnacle 21 validators
  • Manage validation and SEND conformance issues 
  • Validation reports: SEND dataset and define file validation reports from Pinnacle 21 validators

Submission Services

  • Complete submission-ready SEND databases

SEND Data Standardization

  • SEND standardized datasets in XPT format
  • Define.XML and Define.PDF files compliant with CDISC specifications
  • Non-clinical Study Data Reviewer’s Guide (nSDRG)

 

The Atos Syntel Advantage

 
  • Rapid SEND implementation with business-ready infrastructure and highly trained, experienced team on day one
  • Robust onboarding methodology for high-quality SEND and QA processes
  • Strong information security controls to safeguard confidential data
  • Scalability and flexibility to meet your SEND workloads
  • Meet IND and NDA/BLA submission deadlines and reduce risk with Atos Syntel’s strategic technology investments, expertise and process capabilities
  • Process-centric managed services approach for clear accountability and transparency
  • Robust “Quality by Design” methodology to achieve 99+% quality and compliance
  • Well-established governance with flexible engagement and commercial models

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