Our Product

Create Project Create Study SDTM ADaM SEND U P L O A D CRF Data Sets Control Terms Define XML Version Process Merge Validate Generate Study Metadata Generate Define XML Domain Level Variable Level Value Level WhereClause Codelist External Codelist Computation Methods Reference Docs
Our Product Flowchart
  • Lightweight client UI and Cloud based Web Application supporting study types - SDTM/ADaM

  • Pre-loaded with the CDISC Metadata and Control Terminologies.

  • Supports single user and multi user environments with connectivity to a variety of databases

  • Create Study/Upload XPT's & Annotated CRF/Process/View as Define XML - in minutes.

  • Reverse Engineer Define XML from related studies for conversion into Study Metadata.

  • Progressively Add XPT's/Edit Study Metadata/Edit Exception Report and view in Define XML specification format.

  • View and Edit all Exceptions in place in UI

  • View/Edit all levels of the Study Metadata - Domain, Variable, Value, WhereClause, Codelist, External Codelist, Computation Methods and Reference Docs in place

  • Export the Study Metadata as Excel and Re-Import with changes/corrections

  • Configurable to User requirements.

Our Services

Standalone

A lightweight User Interface running on your desktop that will facilitate creation of Project/Study (SDTM/ADaM)/Upload Docs/Process Study Metadata/Generate Define XML.

Cloud Hosted

A secure web based user interface that provides all the functionality of the Standalone application and is available on the cloud for use anytime anywhere.

Services

We manage all your documents such as - CRF, SDTM/ADaM datasets etc. Comments given to us will be incorporated into the metadata. We will generate your define.xml package for submission and with a pdf version (printable) of the define xml.

Process is repetitive and can be used to generate Define XML for 1 XPT at a time or multiple. Versioning allows pulling in data from other versions of the Study Metadata in the system.

A fully featured authorization and authentication mechanism allows this to be a secure multi user environment operating on remote databases or a single user environment with a localized database.

A project dashboard displays the progress of a Project/Study in the workflow.

About us

We are a hard core technology team with multiple years of experience in the Pharmaceutical IT industry building products of a commercial nature. The philosophy we bring to the table is - build and deliver products the Customer wants not what he/she learns to use. Our product is backed by inputs from our In-House SME's and with our strategic partner Symbiance's over two decades of experience in the area of clinical data analysis and regulatory submission.

Strategic Partnerships

We have established a strategic partnership with Symbiance who for over 20 years have been at the cornerstone of the growth of the pharmaceutical and biotechnology industry. As a trusted partner to global pharma leaders, Symbiance is a renowned niche provider of clinical data management, clinical data standardization, biostatistics and medical writing services. Symbiance has a rich roster of clients owing to their commitment to quality and dedication. Symbiance will be using the Define R3 tool to conduct the Study's.

www.symbiance.com

The Team

Saranga Ram

CTO

VasanthaKumar L

System Architect

Prakash P

UI Lead

Ilango Ram

Advisory Board

Eric Weising

Advisory Board

Contact Us