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.
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.
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.
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.
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.
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