Submit™

 

Model: Submit™

Category: Pharmaceutical

Exhibitor: INSTEM INFORMATION SYSTEMS (SHANGHAI) LTD.

Booth No: M1205

 

Characteristic

 

The most widely deployed software suite that is helping clients submit™ with confidence.

Developed to support the life science industry’s Standard for Exchange of Nonclinical Data (SEND) initiative, the submit™ software suite helps improve the speed and quality of new pharmaceutical developments by enabling the efficient exchange of critical study data between sponsors, CROs and regulators.
Submit™软件套件旨在为支持生命科学行业非临床数据交换标准 (SEND) 的倡议而开发，通过在委托方、合同研究组织(CRO) 和监管机构之间高效共享关键研究数据，帮助提高新药开发的速度和质量。

SENDirect™
Submit’s SEND generation capabilities enable organizations to take electronic data from any source and convert it into SEND. The software supports the mapping of terminology, so that customers can continue to collect their data in familiar terms, and automatically convert it to the SEND Controlled Terminology. Our product can also take data for the same study from multiple source systems and blend it together to form a single integrated SEND dataset that corresponds with the study design.

DefineNow™
Quickly create and edit CDISC compliant and submission-ready define.xml files.

GuidePro™
Reduce the time for nSDRG development by up to 50% with our automated guide generator.

SEND Checker
The submit SEND Checker undertakes a comprehensive review of your datasets to ensure they conform to the rules of the current SEND Implementation Guide. These autochecks can be enhanced to provide for sponsor-specific rules and to execute the OpenCDISC checker.

SEND Editor
The SEND Editor provides a valuable tool to enable secure, fully-audited single or bulk edits to be carried out on datasets.

SEND Visualization & Analysis
Powerful software providing value beyond compliance. Create heatmaps for all of your data, view multiple data
graphs at once, view clinical adverse events alongside your Preclinical findings, and much more.

SENDView™
Provides collaborative SEND data review and efficient quality control checking.

SEND Workflow & File Management
Create fully automated workflows for securing and processing SEND datasets and associated documents and
files.

Secure Storage
A sophisticated, version-controlled file storage module provides a long-term storage solution for data files and
SEND datasets.

SEND Producers and Consumers
The submit platform serves the needs of both producers and consumers of SEND data. It recognizes that this is not a hard distinction and that many organizations both create and consume SEND data in the course of their operations. The platform also supports the very wide range of demands that span the needs of the largest multinational pharmaceutical organizations and CROs to the smallest Biotechs and their advisors.

Producers
For producers of SEND, submit provides the tools to bring together data from multiple sources (data collection systems, 3rd party consultants, etc.) and to integrate them to produce a single coherent set of SEND datasets for that study. In addition, our tools provide the environment for datasets to be checked, edited, secured and passed on to the “customer”. Furthermore, we also produce the DEFINE.xml metadata files that accompany
SEND datasets and an outline Study Data Reviewer’s Guide that will enable regulatory reviewers to efficiently navigate the datasets.

Consumers
Consumers, on the other hand, can implement their own electronic workflows that monitor folders, identify the arrival of new datasets, run them through pre-defined workflows and store them in a secure version-controlled repository, all without the need for manual intervention. This means that the user can quickly get to the point of being able to check what they have received, ensure its compliance and then, assuming all is well, forward it on through their submission process when ready.

 

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