scdm.orgSociety for Clinical Data Management (SCDM)
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Title:Society for Clinical Data Management (SCDM)
Description:The Society for Clinical Data Management is a non-profit, international organization of 2,400+ members, serving Clinical Data Management and Research Professionals across the globe.
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Get in touch | Jobs | View jobs | Post a job | My Job Seeker Account | My Employer Account | Join mailing list | | Join SCDM | My SCDM who we are About us Leadership & Governance Bylaws Policies & Procedures Our Partners what we do Certification CURRENT CCDMS® Education Events Publications Clinical Data Science eSource COVID-19 & CDM CCDM Industry Partners Latest News get involved Become a Member RENEW YOUR MEMBERSHIP Become a Volunteer Jobs Corporate Partner Program offices SCDM EMEA SCDM India Past Events 中文 SCDM Japan contact Get in touch Learn more about our discipline I Learn more about our discipline I COVID-19 impact in CDM I Volunteer, get involved I Stay informed, GCDMP© I Learn, expand your horizons I Trusted Global Leader The World’s Leading Advocate for the Discipline of Clinical Data Management Founded in 1994, the Society for Clinical Data Management is going through an exciting time. Artificial intelligence and machine learning are creating new possibilities for our discipline. By integrating thought leadership, education and advocacy – SCDM is shaping the future of clinical data science. To realize our ambitions, we need you to get involved. Expand Your Industry Horizons With SCDM Get involved Join 2000+ clinical data managers, be part of a thriving network Apply for certification Learn about certification, see if you qualify Online education to prepare for SCDM certification, SCDM offers online webinars and courses GCDMP© Use GCDMP standards in your daily work. Stay up to date, download revised chapters Subscribe to updates Leave this field empty if you're human: UPCOMING EVENTS Developing Data Management Plans July 6 - August 2, 2020 Locking the Electronic Data Capture System (EDC3) August 3 - 30, 2020 CRF Design August 31 - September 27, 2020 Processing Lab Data September 28 - October 25, 2020 Influence of the Statistical Analysis Plan (SAP) and Randomization on Data Collection October 26 - November 22, 2020 Data Quality in Clinical Research November 23 - December 22, 2020 NEWS Copyright © 2020 Society for Clinical Data Management. All rights reserved. CDM in 2030 – What the future holds? While it would be presumptuous to attempt to predict what 2030 is about, there are clear signals that it would be vastly different than today. The changes in clinical research approaches, the rapid advances in technologies and the generalization of risk-based approaches endorsed by regulators have all started to reshape our discipline. Some organizations have already successfully embarked into the Artificial Intelligence journey and expect to release data review tools powered by Machine Learning in 2021 (i.e., TOMORROW!). If it was not enough, COVID-19 has added fuel to the fire by accelerating the decentralization of clinical trials. This trend is global and EMEA cannot dodge the bullet. There is no going back, we have past the inflection point leading us toward an exciting but different future. Join the SCDM Innovation Committee Chair if you want to better understand what is looming in front of us. × Risk-based Quality management in CDM This topic will focus on Risk Based Management from a variety of angles including the quality of the data produced. Submissions should focus on matters related to risk-based approaches and how they impact CDM: – RBM’s impact on CDM and visa versa – Risk-based CDM approach – QMP management – QMP with source diversification × Collaboration Internal Teams and Customer Focus This topic should cover the methods of handling the collaboration between customer and clinical data management (i.e. CDM and clinical trial teams, CDM and sites, CMD and CRAs, CDM and subjects, etc.). × Risk-Based Quality Management This topic will focus on Risk Based Management from a variety of angles including the quality of the data produced. × The Fine Art of Clinical Data Management This topic should cover how CDM organization behaves with respect to the CDM community, what are the potential improvements we should work on in the future, what are the lessons learned from past experiences, etc. × Innovation This topic should cover real approaches on new technological and innovation approaches not covered in previous topic and/ or coming not necessarily from CDM (e.g. public health management, finance, physics, etc). × The Future of CDM This topic should focus on real cases showing how academia/ Academic Research Organizations (ARO), CRO and pharma are handling data integrity for eSource, adaptive trial design, how they can assure quality by design, what are their perspectives about actual and potential consequences on CDM, how role & responsibilities are changing and will change in the transformation from CDM to Clinical Data Scientist, what will be the relationship with ‘other’ groups (ClinOps, medics, etc.). × Technology This topic should cover real procedures on Data Management best practices and metrics for different data sources (wearables, apps, sensors, Big Data), application of ML/AI/Bots/Big Data Challenge in data analysis, Computer System Validation processes for home-grown applications/functionalities, new study designs, use of Real-world data in clinical development. × MEETINGS 14 October 2019 Face to Face Meeting Minutes Main Slide Deck Slide Insert for Transcelerate November, 2018 November 07 2017 CDER Health IT Board Agenda October, 2018 Minutes_Agenda_ 27Oct2017_eSourceImplementationConsortiumMeeting_eLabDataWorkingGroupTechnicalCall September, 2018 Agenda_ 29Sep2017_eSourceConsortiumMeeting Agenda_ 15Sep2017_eSourceConsortiumMeeting July, 2018 eSource Consortium Kick Off Meeting Minutes and Action Items 27Jul2017_24Aug2017 March, 2018 eSource Implementation Consortium Operations Agenda Minutes March 16 2018_final eSource Implementation Consortium Technical Agenda Minutes March 30 2018 approved (1) January, 2018 eSource Implementation Consortium Operations Agenda Minutes Feb 16 2018 eSource Implementation Consortium meeting minutes 2018-02-02 eSource Implementation Consortium Operations Agenda Minutes January 19 2018_MB CLOSE AGENDA 08:00 AM – 08:10 AM Introduction to SCDM Mayank Anand Head Global Data Management Service Delivery for Global Clinical Operations, Bristol Myers Squibb (BMS), Member, Board of Trustees SCDM 08:10 AM – 08:20 AM Introduction to First Virtual Single Day Event Shobhit Shrotriya Life Sciences R&D Operations,Accenture, SCDM India Steering Committee Chairperson 08:20 AM – 09:00 AM Keynote Speaker 1 Concept of Virtual Trials in the Current Digital Era Craig Lipset Advisor & Founder, Clinical Innovation Partners 09:00 AM – 09:40 AM Keynote Speaker 2 Virtuals Trials and the Current Covid Situation Kent Thoelke EVP and Chief Scientific Officer, PRA Health Sciences 09:40 AM – 10:20 AM Keynote Speaker 3 Virtual trials from a Technology Perspective with Case Studies Michael Tucker Senior mHealth Product Specialist, Medidata Solutions 10:20 AM – 10:45 AM Break 10:45 AM – 11:30 AM Panel Discussion Reimagining Clinical Research – Enhancing the ‘Patient Centricity’ through Decentralized Clinical Trials 11:30 AM – 12:00 PM Platinum Sponsor Presentation Oracle Health Sciences 12:00 PM – 01:00 PM Lunch Break 01:00 PM – 02:30 PM Industry Workshop 1 Medidata Solutions Virtual Trial Technologies to improve patient enrollment, retention, and engagement 02:30 PM – 03:00 PM Break 03:00 PM – 04:30 PM Industry Workshop 2 Veeva Systems Technologies that improve site, Sponsor and CRO execution of studies, and how can they address global challenges, like COVID-19 04:30 PM – 04:45 PM Vote of Thanks Mayank Anand Head Global Data Management Service Delivery for Global Clinical Operations, Bristol Myers Squibb (BMS), Member, Board of Trustees SCDMShobhit Shrotriya Life Sciences R&D Operations,Accenture, SCDM India Steering Committee Chairperson CLOSE Panel Discussion Facilitator: Shobhit Shrotriya Vice President, Clinical & Regulatory Services, Accenture Applied Life Sciences Solutions Reimagining C...
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