SEND

Smithers Avanza Toxicology Services is SEND ready and offers services in partnership with PointCross Life Sciences to help clients comply with the FDA’s upcoming mandate.

View the press release

We recommend the use of a Standard for Electronic Nonclinical Data (SEND) technical rehearsal process in order to:

Proactively explain, discuss and define SEND requirements
Define roles and responsibilities for all parties involved in the study and ensure that they understand their role in the overall SEND submission process.
Define data specifications
Define trial design, study domains and variables, controlled and preferred terminology lists, and naming conventions
Use a single data source for the creation of SEND datasets and the study report
Ensure that process checks are in place to assure conformance to specifications and data quality and integrity.
Capture metrics for assessment of costs and timeline impacts

The long-term benefit of such a technical rehearsal is that it allows sponsors to define standard business practices across all data providers. Modeling your SEND process in advance, with us, will avoid delays in your submissions and facilitate a smooth regulatory review.

PointCross Life Sciences is the leading provider of data viewing, repository, Standard for Electronic Nonclinical Data (SEND) workflow and data standardization solutions to both the FDA and industry.  The FDA NIMS system including ToxVision used for the review of SEND data is based on PointCross technology.

Through our partnership with PointCross, we provide clients with the following services:

  • Submission-ready SEND packages fit for FDA review – these include complete SEND datasets from across all study data providers, the define file, and the Study Data Reviewer’s Guides (SDRG). Learn more about this service
  • Defining your SEND data plan – we help reduce costs, improve data quality and avoid delays by planning for SEND prior to the study start. We collaborate with the sponsor and all contractors to specify expectations for datasets, naming conventions, and terminologies from each data provider.  Learn more about this service
  • Assurance that your SEND datasets and Study Reports are consistent, complete and fit for FDA review. Learn more about this offering
  • Interim data supply – we offer a service to provide sponsors with interim data in SEND format for use in project reviews over the course of a study.
  • Access to ToxVision SaaS to visualize your SEND data and to conduct data quality checks against your study report. This is the identical tool used by the FDA to review your SEND submissions. Learn more about ToxVision
  • Business process consulting to prepare your organization and data providers for SEND

Resources to help you prepare for FDA SEND Compliance