Robert Paarlberg

Full Disclosure: Meet the Clinical Trial Disclosure Community

Found in: Article, Clinical Data Management, Clinical Data Management, Professional Development, Professional Education, Training & Development, Regulatory Affairs

The DIA Clinical Trial Disclosure (CTD) Community provides a forum for discussing and sharing clinical trial disclosure and...

Operationalizing a New Regulation

By Francine Lane Found in: Article, Clinical Trial Disclosure, Clinical Data Management, Clinical Data Management, Regulatory Affairs

New regulations cause a scramble to understand them, their impacts, and the timelines required to move from words in a...

The Impact of Innovation - How the Changing Nature of Data Will Challenge FDA’s Regulatory Framework

By Michael Doherty, DMS; Nancy Bradish Myers, JD; Anne Petruska McNickle, BA Found in: Article, Clinical Data Management, Clinical Data Management, Clinical Data Management / eClinical, Safety & Pharmacovigilance

Rapid advances in technology and our understanding of disease will lead to a shift in how the health care system thinks...

Optimizing Clinical Trial Electronic Data Sources

By Ed Kellar, MS; Susan M. Bornstein, MPH; Aleny Caban, BS; Catherine Célingant, MA; Michelle Crouthamel, MS; Chrissy Johnson, MS; Patricia A. McIntire, BSc; Kenneth R. Milstead, MS; Jaclyn K. Patterson, BS; Brett Wilson, BSP Found in: Article, eClinical, Clinical Data Management, Clinical Data Management, Clinical Research

TransCelerate BioPharma has created the eSource Initiative with the intent to facilitate the industry’s movement toward...

IOM Report on Sharing Clinical Trial Data

By Harold Glass, PhD; Christine Pierre, Society for Clinical Research Sites; DIA Global Forum Content Editors for Clinical Trials: Design Tools and Management Found in: Article, Clinical Data Management, Clinical Data Management, Clinical Research, Clinical Trial Disclosure, Hot Topic, Patient Engagement

Sharing clinical trial data, in particular individual patient data, constitutes a major opportunity for new drug development and…

Clinical Data Transparency

By Janet Woodcock, MD, Director, CDER, FDA; Anne M. Rowzee, PhD, Lead Writer/Editor, Division of Online Communications, FDA Found in: Article, Clinical Data Management / eClinical, Clinical Data Management, Clinical Trial Disclosure

Many developments have brought clinical trial data transparency to the forefront of our stakeholders’ minds – from the expanding...

Robert Paarlberg

Full Disclosure: Meet the Clinical Trial Disclosure Community

Found in: Article, Clinical Data Management, Clinical Data Management, Professional Development, Professional Education, Training & Development, Regulatory Affairs

The DIA Clinical Trial Disclosure (CTD) Community provides a forum for discussing and sharing clinical trial disclosure and...

Operationalizing a New Regulation

By Francine Lane Found in: Article, Clinical Trial Disclosure, Clinical Data Management, Clinical Data Management, Regulatory Affairs

New regulations cause a scramble to understand them, their impacts, and the timelines required to move from words in a...

The Impact of Innovation - How the Changing Nature of Data Will Challenge FDA’s Regulatory Framework

By Michael Doherty, DMS; Nancy Bradish Myers, JD; Anne Petruska McNickle, BA Found in: Article, Clinical Data Management, Clinical Data Management, Clinical Data Management / eClinical, Safety & Pharmacovigilance

Rapid advances in technology and our understanding of disease will lead to a shift in how the health care system thinks...

Optimizing Clinical Trial Electronic Data Sources

By Ed Kellar, MS; Susan M. Bornstein, MPH; Aleny Caban, BS; Catherine Célingant, MA; Michelle Crouthamel, MS; Chrissy Johnson, MS; Patricia A. McIntire, BSc; Kenneth R. Milstead, MS; Jaclyn K. Patterson, BS; Brett Wilson, BSP Found in: Article, eClinical, Clinical Data Management, Clinical Data Management, Clinical Research

TransCelerate BioPharma has created the eSource Initiative with the intent to facilitate the industry’s movement toward...

IOM Report on Sharing Clinical Trial Data

By Harold Glass, PhD; Christine Pierre, Society for Clinical Research Sites; DIA Global Forum Content Editors for Clinical Trials: Design Tools and Management Found in: Article, Clinical Data Management, Clinical Data Management, Clinical Research, Clinical Trial Disclosure, Hot Topic, Patient Engagement

Sharing clinical trial data, in particular individual patient data, constitutes a major opportunity for new drug development and…

Clinical Data Transparency

By Janet Woodcock, MD, Director, CDER, FDA; Anne M. Rowzee, PhD, Lead Writer/Editor, Division of Online Communications, FDA Found in: Article, Clinical Data Management / eClinical, Clinical Data Management, Clinical Trial Disclosure

Many developments have brought clinical trial data transparency to the forefront of our stakeholders’ minds – from the expanding...