Dec 05, 2023 Unlocking the Power of Data with a Data-Focused Biometrics Service... In today’s evolving clinical research and drug development landscape, with more data sources and technology... Learn more
Jul 24, 2023 CRO Collaboration that Fuels Innovation for Specialty Biotechs: Bioforum and... For many sponsors of clinical trials, particularly the smaller pharmaceutical, biotech, and medical device companies,... Learn more
May 22, 2023 Bioforum & Abiomed Partnership Case Study: How A Long-Term Data... Background In October 2022, Abiomed, a leading provider of medical technology focused on mechanical circulatory... Learn more
Feb 01, 2023 LEVERAGING MACHINE-LEARNING FOR SDTM MAPPING by Sharon Rossouw EXECUTIVE SUMMARY Data standards support the robust organization, analysis, and reporting of... Learn more
Dec 22, 2022 CASE STUDY – HIGH-LEVEL COMMITMENT AND EXPERTISE ENABLING THE SUBMISSION... Introduction The submission of a New Drug Application (NDA) to regulatory authorities and its subsequent... Learn more
Nov 08, 2022 How Can Sponsors and CROs Execute SDTM Faster With Lower... Background When a patient presents with a fever or what appears to be an acute... Learn more
Jan 17, 2022 Ensuring Clinical Trial Data Integrity: Five Things to Remember When... Ensuring Clinical Trial Data Integrity: Five Things to Remember When Selecting a CRO Partner ... Learn more
May 19, 2019 Benefits of Automating, Accelerating and Unifying the SDTM Conversion Process In light of regulatory requirements, CDISC SDTM is now the leading standard for representing clinical... Learn more
Oct 24, 2018 What Is CRO Data Management, and What Are Its Benefits? The International Conference on Harmonization Good Clinical Practice (ICH-GCP) defines the Sponsor of a clinical... Learn more
Oct 24, 2018 Regulatory Landscape Clinical study data is defined by the FDA as information about a person in a... Learn more
Oct 24, 2018 At A Glance – What’s New In The FDA Technical... The FDA has recently published a new version of the Technical Conformance Guide (TCG) with updates that... Learn more
Oct 24, 2018 Study Data Standardization Plan – Importance And Advantages The SDSP (Study Data Standardization Plan) is a document intended to communicate to CDER (Center for... Learn more