Enable Your Drug Development CMC Digital Transformation Strategy with a Structured Content and Data Management (SCDM) Guided Workflow System

A webinar sponsored by Astrix 

Date: May 29th, 2024

Time:  1:00 PM EST / 10:00 AM PST

Presented by:

David Cronin, Founder, Cognition

Overview

The Chemistry, Manufacturing, and Controls (CMC) Module 3 component of the Common Technical Document (CTD) required for pharmaceutical regulatory submissions requires extensive documentation, including drug substance and drug product information, manufacturing processes, analytical methods, stability studies, and more. Managing the manual transcription and compilation of this documentation consisting of text annotations, images, data, tables, etc. from various sources while ensuring accuracy, consistency, clarity, and coherence across different sections of the report can be very challenging and can often times result in data integrity errors and risks.

This webinar will provide valuable insights into

• What is the value of using a Structured Content & Data Management (SCDM) guided workflow solution in biotech and pharmaceutical product development?
• Why are the CMC Module 3 data, content, and tables report generation challenges so difficult?
• How can I improve data integrity, minimize errors, redundancies, and discrepancies, while enhancing the reliability and accuracy of information of my CMC Module 3 and other e-Reports?
• Who can benefit from the Compass BIO® solution which can enable the automatic generation of complex data tables and reports and the ability to use a single set of data tables and reports throughout the entire development process with dynamic links between data items, and collections/containers of data items?
• When in biotech and pharmaceutical product development could a SCDM guided workflow solution be used?

Compass BIO®  has been strategically developed as a Structured Content and Data Management (SCDM) system with a suite of configurable applications software for product development and CMC Module 3 reports that automates data pipelines and includes both analytical and process reporting. Specifically created for Biopharma and CDMO companies, this innovative CMC software solution is an essential to help navigate, organize, and generate the complex data tables and reports required for data management of projects and regulatory submissions without requiring manual data transcription and extensive data integrity checking. The out-of-the-box configurable suite of software applications, which support both large molecule (biologics) and traditional small molecule products, provide a virtual guided workflow system that enables teams to use a single set of data tables & reports from source to submission.

About Cognition Corporation

Cognition Corporation has 25+ years of experience developing, selling, and supporting product development and compliance software solutions for the medical devices and biopharma industries. Our Software-as-a-Service solutions help development teams meet regulations faster with real-time traceability, guided design controls, and change once, update everywhere functionality – turning manual and disconnected data into streamlined, structured submissions. Cognition is a recognized leader in understanding and developing innovative Structured Content and Data Management guided workflow solutions for improving product development processes.