Solutions

Define Bot

Agati’s solution to present the metadata of the clinical trial data, that is being submitted to the agency, in Define.XML structure as per CDISC standards. DefineBot significantly reduces the time to create define.xml by automating the Origin, CodeLists, Controlled Terminologies, Value Level Meta Data and WhereClause sections of define.xml as per submission standards.

 

DefineBot’s advantages are:

  • 21 CFR Part 11 Compliance

  • Built-in validation rules to ensure CDISC standards compliance

  • NCI CT updates and standards metadata uploads

  • Built-in XML schema validator

  • Origin identification, code lists and NCI CTs are automated for efficiency

  • Define.xml in hours not in days or weeks

Submit Bot

Agati’s SubmitBot product addresses the pains and nuances involved in document publishing and regulatory submission packaging in the eCTD structure. It takes away the difficulties involved in document level publishing activity and automates the submission package creation by tremendously reducing the time to create the final package ready for submission to any regulatory agency.

Key Features of SubmitBot:

  • Supports multiple agencies including FDA, EU, CA, CH, SFDA, TGA, MCC, JP to create eCTD submissions

  • Valid eCTD submissions/sequences created by other tools can be imported into SubmitBot

  • Automatic PDF conversions, agency recommended PDF settings and In-Place PDF editing within the SubmitBot application

  • No dependency on other third-party tool for hyper-linking and book-marking

  • Comprehensive Study Tagging File (STF) creation and easy Life cycle Management (LCM)

  • Reduced time and effort through Library feature which help in reusing the common modules prepared for other agencies

  • In-built DMS (Document Management System) module for document life cycle management

Transbot 

Agati team has leveraged our expertise in clinical data standards and technology to build TransBot solution that automates and accelerates the data transformation of non-standard clinical data into a standard format like SEND, SDTM and ADaM. TransBot offers metadata driven automation that complies with 21 CFR Part 11 regulatory guidance and industry standards like CDISC.

TransBot has the following advantages:

  • Metadata driven end-to-end transformation

  • Internet browser-based User Interface

  • Data and documents in central repository

  • Visual transformation blocks

  • Standards compliance with CDISC ODM/SEND/SDTM/ADaM/Define.xml

  • Multiple data source formats XLS, CSV, XPT, ASCII delimited text

  • Annotations, source/target metadata and data views in UI

  • Updates to standards and custom standards through metadata management

Contact Info

USA

13057, Condit Ranch Road, Frisco, TX - 75035

GERMANY

Hoersterstrasse 43, 48143, Muenster

INDIA

CHENNAI

Dev's Ark,2nd Floor, 284/1B,Old Mahabalipuram Road. Perungudi, Chennai, Tamil Nadu 600096

BENGALURU

No.447, 17th Cross, 17th Main, Sector-4,

HSR Layout, Bengaluru - 560102.

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