Navigation Links
TransCelerate BioPharma Inc. Releases Recommended Approach for Protecting Personal Data in Clinical Study Reports
Date:9/2/2014

PHILADELPHIA, Sept. 2, 2014 /PRNewswire/ -- TransCelerate BioPharma Inc. ("TransCelerate") today announced that it has developed a recommended approach for protecting personal data in Clinical Study Reports (CSRs) that are shared with researchers, patients and others. The document describes an approach to apply when redacting or removing personal information from CSRs and other related clinical trial documents, and is available here.

The goal of the TransCelerate CSR Redaction approach is to provide organizations that share CSRs with a consistent way of protecting personal data that is contained in these documents. Information in CSRs will be removed or redacted in order to protect the privacy of patients and those associated with a clinical trial.

"Through the implementation of this approach and additional forthcoming work from this team, TransCelerate will aid in simplifying and operationalizing enhanced transparency, while safeguarding the privacy of individuals involved in clinical trials," said Dalvir Gill, PhD, Chief Executive Officer of TransCelerate. "By developing and providing a consistent approach, TransCelerate continues to drive efficiencies that will help ensure industry resources are focused on improving the health of people around the world."

The approach provides practical details to help implement the July 2013 commitment by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) member companies titled, "Principles for Responsible Clinical Trial Data Sharing."

"Increasing transparency of clinical trial information by making clinical study reports more widely available is a goal we all share. This must be done in ways that protect the privacy of those involved, and the adoption of a consistent approach is an important step forward," said Andrew Freeman, Director and Head of Medical Policy at GlaxoSmithKline, and TransCelerate Clinical Data Transparency initiative co-lead.

About TransCelerate BioPharma Inc.
TransCelerate BioPharma Inc. is a non-profit organization dedicated to improving the health of people around the world by accelerating and simplifying the research and development (R&D) of innovative new therapies. The organization's mission is to collaborate across the global R&D community to identify, prioritize, design and facilitate implementation of solutions designed to drive the efficient, effective and high quality delivery of medicines. TransCelerate evolved from discussions at various forums for executive R&D leadership to debate current issues facing the industry and examine solutions for addressing agreed-upon common challenges. The founding member companies are AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, the Roche Group and Sanofi. Additional members that have joined since the inception of TransCelerate include Allergan, Inc., Astellas Pharma Inc., Biogen Idec, Cubist Pharmaceuticals, EMD Serono, Inc. (a subsidiary of Merck KGaA, Darmstadt, Germany), Forest Research Institute (a subsidiary of Forest Laboratories, Inc.), Medgenics, Inc., Shionogi & Co., Ltd. and UCB.

Membership in TransCelerate is open to pharmaceutical and biotechnology companies with Research and Development operations. Executive offices are located in Philadelphia, PA. For more information, please visit http://www.transceleratebiopharmainc.com/.

Media Contact:

Seema Kumar
Chair – TransCelerate BioPharma Inc. Communications Committee
(908) 218-6460
skumar10@its.jnj.com

Shannon Caudill
(740) 281-3715 or (614) 378-9042
shannon.caudill@porternovelli.com

 


'/>"/>
SOURCE TransCelerate BioPharma Inc.
Copyright©2014 PR Newswire.
All rights reserved

Related biology technology :

1. TransCelerate BioPharma Inc. Appoints Dalvir Gill as Chief Executive Officer
2. TransCelerate BioPharma Inc. Takes Steps Toward Common Clinical Trial Site Qualification & Training
3. CDISC and TransCelerate BioPharma Inc. Announce Landmark Asthma Data Standard Released for Public Review
4. TransCelerate BioPharma Inc. Launches Second Year Initiatives, Expands Membership and Achieves Milestones for Original Projects
5. TransCelerate, Lilly, Pfizer, and FDA Highlight Collaborative Program at the Site Solutions Summit
6. Keryx Biopharmaceuticals, Inc. Announces Upcoming Poster Presentations of Zerenex™ (Ferric Citrate) at the Upcoming American Society of Nephrology Kidney Week 2011 Annual Meeting
7. PDL BioPharma Announces Adjusted Conversion Rates for Its Convertible Notes
8. CeNeRx BioPharma Completes $4.85 Million Financing
9. PDL BioPharma Completes Regular Quarterly Dividend Payment
10. PAREXEL Introduces Executive Briefing Series on Proven Practices to Assist Emerging and Mid-size Biopharma in Achieving Better Outcomes
11. Inspiration Biopharmaceuticals Moves Corporate Headquarters to Cambridge, Massachusetts
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016 On ... session at 4,833.32, down 0.22%; the Dow Jones Industrial Average ... 500 closed at 2,085.45, down 0.17%. Stock-Callers.com has initiated coverage ... INFI ), Nektar Therapeutics (NASDAQ: NKTR ), Aralez ... Inc. (NASDAQ: BIND ). Learn more about these ...
(Date:6/23/2016)... ... June 23, 2016 , ... Regulatory Compliance Associates® ... provides a free webinar on Performing Quality Investigations: Getting to Root ... CT at no charge. , Incomplete investigations are still a major concern to ...
(Date:6/23/2016)... June 22, 2016  Amgen (NASDAQ: AMGN ... QB3@953 life sciences incubator to accelerate the ... shared laboratory space at QB3@953 was created to help ... obstacle for many early stage organizations - access to ... sponsorship, Amgen launched two "Amgen Golden Ticket" awards, providing ...
(Date:6/22/2016)... Cell Applications, Inc. and StemoniX announced ... up to one billion human induced pluripotent stem ... These high-quality, consistent stem cells enable researchers to ... more time doing meaningful, relevant research. This achievement ... process that produces affordable, reliable HiPSC for life ...
Breaking Biology Technology:
(Date:5/16/2016)...   EyeLock LLC , a market leader of ... an IoT Center of Excellence in Austin, ... of embedded iris biometric applications. EyeLock,s iris ... security with unmatched biometric accuracy, making it the most ... EyeLock,s platform uses video technology to deliver a fast ...
(Date:4/28/2016)... First quarter 2016:   , Revenues amounted to ... of 2015 The gross margin was 49% (27) ... operating margin was 40% (-13) Earnings per share rose ... was SEK 249.9 M (21.2) , Outlook   ... The operating margin for 2016 is estimated to exceed ...
(Date:4/15/2016)... , April 15, 2016 ... the,  "Global Gait Biometrics Market 2016-2020,"  report to ... http://photos.prnewswire.com/prnh/20160330/349511LOGO ) , ,The global gait biometrics ... of 13.98% during the period 2016-2020. ... angles, which can be used to compute factors ...
Breaking Biology News(10 mins):