Xtend for SEND

In the biotech and pharmaceutical industry there must be absolute trust in the veracity and validity of the non-clinical study data that is collected and shared; across departments in an organization, between pharma and CRO companies and with the regulatory agencies.

PointCross Xtend™ for SEND provides a single environment to create, validate, store, exchange, view and report study data in a secure standards-compliant environment. SEND solutions currently being built by some of the LIMS solutions providers are intended to work narrowly with their proprietary LIMS or data collection system. These solutions might be able to output the data they collect into SEND format. However these SEND compatible data sets are of limited value because they do not feed into a common vendor neutral data repository.

PointCross Xtend for SEND Features :

• Handles both SEND and non-SEND data and metadata
• Creates a searchable repository of study data and metadata
• Securely manages data flows and workflows across the CRO-sponsor-Agency network, and
• Includes ToxVision - used by the FDA reviewers for viewing, analyzing and searching submitted nonclinical study data.
  
  

Xtend for SEND is a standards driven study data exchange transport model. At the center is the core SEND Standard Model currently at version 3.0. The first extension in Xtend for SEND represents study data types (e.g., reproductive toxicity, safety pharmacology, genetic toxicology, ...) that are not presently covered by the CDISC SEND data model. The second extension in Xtend for SEND represents the extended data model covering:

• Non-GLP study and assay data
• Metadata about the validated study data including header information, transformation rules, annotations and file attachments The complete Xtend for SEND environment allows companies and agencies to exchange study data in a fluid, safe, and traceable manner.
  
  

System and Network Configuration
Xtend for SEND can be installed behind an enterprise firewall or provided through a public cloud. The purpose of Xtend for SEND is to not only support internal data extraction/integration/reporting needs, but to also exchange data with other organizations outside of the enterprise network. Even if installed behind the enterprise firewalls, it is necessary for the server to be connected to a trusted server on the DMZ (Data Management Zone ) or perimeter network so that data can be exchanged with other external servers using secure HTTPS transfer. It is possible to augment HTTPS transfers with secure batch-wise SMTP transfers.

Xtend for SEND can additionally be delivered as SaaS (Software as a Service). Its presence through the cloud ensures high performance and scalability, and provides flexibility in exchanging data with multiple CROs. There is no constraint or limitations imposed because the only connection that the Xtend for SEND needs to the legacy systems are to the LIMS validated systems.

• Product Brief