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

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

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, Clinical 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 Development & Operations

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 Development & Operations, 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

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

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, Clinical 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 Development & Operations

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 Development & Operations, 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...