How to Use Fix Tips for Better Clinical Data Issue Management Blog How to Use Fix Tips for Better Clinical Data Issue Management 2025年4月15日 Prior to submission to any regulatory agency, standardized study data is evaluated using at…Simona Colucci2025年4月15日
Standardizing Real World Data in Rare Disease: ATHN’s Journey Case Study Standardizing Real World Data in Rare Disease: ATHN’s Journey The American Thrombosis and Hemostasis Network (ATHN), a not-for-profit organization, has been improving care and…Danielle Pillsbury2025年4月8日
How to Make 3rd Party Reconciliation in Clinical Data Management More Efficient Blog How to Make 3rd Party Reconciliation in Clinical Data Management More Efficient Learn how to streamline 3rd party reconciliation in clinical data management with reusable standards, centralized…Simona Colucci2025年3月31日
The Revolution of Metadata Standardization with Clinical Metadata Repository (CMDR) Webinar The Revolution of Metadata Standardization with Clinical Metadata Repository (CMDR) 2025年4月22日 - 10:00 am – 10:45 am, Japan timeDanielle Pillsbury2025年3月27日
Exploring Common CDISC ADaM Conformance Findings Blog Exploring Common CDISC ADaM Conformance Findings 2025年3月27日 ADaM data are required by the FDA and PMDA and accepted by…Simona Colucci2025年3月27日
Maximizing Clinical Efficiency: Simplifying SDTM Dataset workflow with the power of standardized metadata [APAC Webinar] On-Demand Webinar 臨床的な効率を最大化:標準化されたメタデータの力を使ってSDTMデータセットワークフローを簡略化[APACウェビナー] Lorem ipsum dolor sit amet consectetur. Donec diam risus volutpat tempor. Massa accumsan aliquam nibh…Danielle Pillsbury2025年3月11日
CDISC data standards – Beyond value [Korean Webinar] On-Demand Webinar CDISCデータ標準 – 価値を越える [韓国ウェビナー] 2025年3月13日 - 3:00 pm KoreaDanielle Pillsbury2025年3月3日
Pinnacle 21 – Data standardization and validation for faster analysis and submission Video Pinnacle 21 – Data standardization and validation for faster analysis and submission Danielle Pillsbury2025年3月3日
Standards for All: Controlling Your Metadata for Vendors, Study Sites, and Submission Datasets On-Demand Webinar Standards for All: Controlling Your Metadata for Vendors, Study Sites, and Submission Datasets Director of Product, Certara's Pinnacle 21Senior Principal CDISC Consultant, Certara's Pinnacle 21Achieve submission ready conformance…Danielle Pillsbury2025年2月7日
How to Validate Your Clinical Data Using FDA Validation Rules Blog FDAのバリデーションルールを用いた臨床データのバリデーション方法 2025年1月30日 For clinical data managers, understanding clinical data validation and applying FDA validation…Danielle Pillsbury2025年1月30日