SCDM eSource Playbook 3: Practical advice for pharma

Clinical research is in the midst of a digital transformation, with the emergence of eSource data promising to accelerate drug development timelines, enhance patient centricity, and unlock previously unseen insights. While much has been written on the rationale for eSource approaches, practical advi...

Full description

Saved in:
Bibliographic Details
Published in:Journal of the Society for Clinical Data Management 2023-10, Vol.3 (5)
Main Authors: King, Linda, Ansari, Naqib, Jaskowska, Magda A, McCabe, Lauren, Mirza, Muzafar, Angiolelli, Joseph, Casteleyn, Peter, Maniar, Rakesh, Ammour, Nadir
Format: Article
Language:English
Citations: Items that this one cites
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
cited_by
cites cdi_FETCH-LOGICAL-c713-70c1c5bd1d71eddf902a41f827781992676295532245bbd6309e7c5e107da10d3
container_end_page
container_issue 5
container_start_page
container_title Journal of the Society for Clinical Data Management
container_volume 3
creator King, Linda
Ansari, Naqib
Jaskowska, Magda A
McCabe, Lauren
Mirza, Muzafar
Angiolelli, Joseph
Casteleyn, Peter
Maniar, Rakesh
Ammour, Nadir
description Clinical research is in the midst of a digital transformation, with the emergence of eSource data promising to accelerate drug development timelines, enhance patient centricity, and unlock previously unseen insights. While much has been written on the rationale for eSource approaches, practical advice on their implementation has been less widely available. As the world's leading advocate for the discipline of clinical data management, the Society for Clinical Data Management (SCDM) is in a unique position to fill this knowledge gap. To achieve this aim, the group has produced a series of podcasts in which leading experts from across the clinical research ecosystem share their case studies and practical advice on moving eSource from theory into practice. We then distilled their learnings into four playbooks, each from the standpoint of one of the main stakeholder groups: CRO and vendors, pharma, regulators, and academia/sites. This paper focuses on the pharma perspective.
doi_str_mv 10.47912/jscdm.263
format article
fullrecord <record><control><sourceid>crossref</sourceid><recordid>TN_cdi_crossref_primary_10_47912_jscdm_263</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>10_47912_jscdm_263</sourcerecordid><originalsourceid>FETCH-LOGICAL-c713-70c1c5bd1d71eddf902a41f827781992676295532245bbd6309e7c5e107da10d3</originalsourceid><addsrcrecordid>eNpNz0tLAzEUBeAgCpbajb8ga2Fqbl534k5GrUJLC-0-ZPLAqTNMSVTov7dUF67OgQMHPkJugc0lGuD3--LDMOdaXJAJ10ZWIFFc_uvXZFbKnjHGa5SmNhMit83Tisbt-JV9pJveHdtx_KDigW6y85-ddz114bs7jWnM9PDu8uBuyFVyfYmzv5yS3cvzrnmtluvFW_O4rDyCqJB58KoNEBBiCMkw7iSkmiPWYAzXqLlRSnAuVdsGLZiJ6FUEhsEBC2JK7n5vfR5LyTHZQ-4Gl48WmD2L7VlsT2LxA7EbRzc</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>SCDM eSource Playbook 3: Practical advice for pharma</title><source>EZB Electronic Journals Library</source><creator>King, Linda ; Ansari, Naqib ; Jaskowska, Magda A ; McCabe, Lauren ; Mirza, Muzafar ; Angiolelli, Joseph ; Casteleyn, Peter ; Maniar, Rakesh ; Ammour, Nadir</creator><creatorcontrib>King, Linda ; Ansari, Naqib ; Jaskowska, Magda A ; McCabe, Lauren ; Mirza, Muzafar ; Angiolelli, Joseph ; Casteleyn, Peter ; Maniar, Rakesh ; Ammour, Nadir</creatorcontrib><description>Clinical research is in the midst of a digital transformation, with the emergence of eSource data promising to accelerate drug development timelines, enhance patient centricity, and unlock previously unseen insights. While much has been written on the rationale for eSource approaches, practical advice on their implementation has been less widely available. As the world's leading advocate for the discipline of clinical data management, the Society for Clinical Data Management (SCDM) is in a unique position to fill this knowledge gap. To achieve this aim, the group has produced a series of podcasts in which leading experts from across the clinical research ecosystem share their case studies and practical advice on moving eSource from theory into practice. We then distilled their learnings into four playbooks, each from the standpoint of one of the main stakeholder groups: CRO and vendors, pharma, regulators, and academia/sites. This paper focuses on the pharma perspective.</description><identifier>ISSN: 2694-1473</identifier><identifier>EISSN: 2694-1473</identifier><identifier>DOI: 10.47912/jscdm.263</identifier><language>eng</language><ispartof>Journal of the Society for Clinical Data Management, 2023-10, Vol.3 (5)</ispartof><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c713-70c1c5bd1d71eddf902a41f827781992676295532245bbd6309e7c5e107da10d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids></links><search><creatorcontrib>King, Linda</creatorcontrib><creatorcontrib>Ansari, Naqib</creatorcontrib><creatorcontrib>Jaskowska, Magda A</creatorcontrib><creatorcontrib>McCabe, Lauren</creatorcontrib><creatorcontrib>Mirza, Muzafar</creatorcontrib><creatorcontrib>Angiolelli, Joseph</creatorcontrib><creatorcontrib>Casteleyn, Peter</creatorcontrib><creatorcontrib>Maniar, Rakesh</creatorcontrib><creatorcontrib>Ammour, Nadir</creatorcontrib><title>SCDM eSource Playbook 3: Practical advice for pharma</title><title>Journal of the Society for Clinical Data Management</title><description>Clinical research is in the midst of a digital transformation, with the emergence of eSource data promising to accelerate drug development timelines, enhance patient centricity, and unlock previously unseen insights. While much has been written on the rationale for eSource approaches, practical advice on their implementation has been less widely available. As the world's leading advocate for the discipline of clinical data management, the Society for Clinical Data Management (SCDM) is in a unique position to fill this knowledge gap. To achieve this aim, the group has produced a series of podcasts in which leading experts from across the clinical research ecosystem share their case studies and practical advice on moving eSource from theory into practice. We then distilled their learnings into four playbooks, each from the standpoint of one of the main stakeholder groups: CRO and vendors, pharma, regulators, and academia/sites. This paper focuses on the pharma perspective.</description><issn>2694-1473</issn><issn>2694-1473</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><recordid>eNpNz0tLAzEUBeAgCpbajb8ga2Fqbl534k5GrUJLC-0-ZPLAqTNMSVTov7dUF67OgQMHPkJugc0lGuD3--LDMOdaXJAJ10ZWIFFc_uvXZFbKnjHGa5SmNhMit83Tisbt-JV9pJveHdtx_KDigW6y85-ddz114bs7jWnM9PDu8uBuyFVyfYmzv5yS3cvzrnmtluvFW_O4rDyCqJB58KoNEBBiCMkw7iSkmiPWYAzXqLlRSnAuVdsGLZiJ6FUEhsEBC2JK7n5vfR5LyTHZQ-4Gl48WmD2L7VlsT2LxA7EbRzc</recordid><startdate>20231009</startdate><enddate>20231009</enddate><creator>King, Linda</creator><creator>Ansari, Naqib</creator><creator>Jaskowska, Magda A</creator><creator>McCabe, Lauren</creator><creator>Mirza, Muzafar</creator><creator>Angiolelli, Joseph</creator><creator>Casteleyn, Peter</creator><creator>Maniar, Rakesh</creator><creator>Ammour, Nadir</creator><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>20231009</creationdate><title>SCDM eSource Playbook 3: Practical advice for pharma</title><author>King, Linda ; Ansari, Naqib ; Jaskowska, Magda A ; McCabe, Lauren ; Mirza, Muzafar ; Angiolelli, Joseph ; Casteleyn, Peter ; Maniar, Rakesh ; Ammour, Nadir</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c713-70c1c5bd1d71eddf902a41f827781992676295532245bbd6309e7c5e107da10d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>King, Linda</creatorcontrib><creatorcontrib>Ansari, Naqib</creatorcontrib><creatorcontrib>Jaskowska, Magda A</creatorcontrib><creatorcontrib>McCabe, Lauren</creatorcontrib><creatorcontrib>Mirza, Muzafar</creatorcontrib><creatorcontrib>Angiolelli, Joseph</creatorcontrib><creatorcontrib>Casteleyn, Peter</creatorcontrib><creatorcontrib>Maniar, Rakesh</creatorcontrib><creatorcontrib>Ammour, Nadir</creatorcontrib><collection>CrossRef</collection><jtitle>Journal of the Society for Clinical Data Management</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>King, Linda</au><au>Ansari, Naqib</au><au>Jaskowska, Magda A</au><au>McCabe, Lauren</au><au>Mirza, Muzafar</au><au>Angiolelli, Joseph</au><au>Casteleyn, Peter</au><au>Maniar, Rakesh</au><au>Ammour, Nadir</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>SCDM eSource Playbook 3: Practical advice for pharma</atitle><jtitle>Journal of the Society for Clinical Data Management</jtitle><date>2023-10-09</date><risdate>2023</risdate><volume>3</volume><issue>5</issue><issn>2694-1473</issn><eissn>2694-1473</eissn><abstract>Clinical research is in the midst of a digital transformation, with the emergence of eSource data promising to accelerate drug development timelines, enhance patient centricity, and unlock previously unseen insights. While much has been written on the rationale for eSource approaches, practical advice on their implementation has been less widely available. As the world's leading advocate for the discipline of clinical data management, the Society for Clinical Data Management (SCDM) is in a unique position to fill this knowledge gap. To achieve this aim, the group has produced a series of podcasts in which leading experts from across the clinical research ecosystem share their case studies and practical advice on moving eSource from theory into practice. We then distilled their learnings into four playbooks, each from the standpoint of one of the main stakeholder groups: CRO and vendors, pharma, regulators, and academia/sites. This paper focuses on the pharma perspective.</abstract><doi>10.47912/jscdm.263</doi><oa>free_for_read</oa></addata></record>
fulltext fulltext
identifier ISSN: 2694-1473
ispartof Journal of the Society for Clinical Data Management, 2023-10, Vol.3 (5)
issn 2694-1473
2694-1473
language eng
recordid cdi_crossref_primary_10_47912_jscdm_263
source EZB Electronic Journals Library
title SCDM eSource Playbook 3: Practical advice for pharma
url http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-01T12%3A32%3A29IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-crossref&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=SCDM%20eSource%20Playbook%203:%20Practical%20advice%20for%20pharma&rft.jtitle=Journal%20of%20the%20Society%20for%20Clinical%20Data%20Management&rft.au=King,%20Linda&rft.date=2023-10-09&rft.volume=3&rft.issue=5&rft.issn=2694-1473&rft.eissn=2694-1473&rft_id=info:doi/10.47912/jscdm.263&rft_dat=%3Ccrossref%3E10_47912_jscdm_263%3C/crossref%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c713-70c1c5bd1d71eddf902a41f827781992676295532245bbd6309e7c5e107da10d3%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_id=info:pmid/&rfr_iscdi=true