Authors


Roxanne Cox

Latest:

Breaking Down OHRP Assurances

This article will focus on specific requirements to ensure the Protection of Human Research Subjects (Title 45 CFR 46).


Susan E. Vogel

Latest:

Breaking Down OHRP Assurances

This article will focus on specific requirements to ensure the Protection of Human Research Subjects (Title 45 CFR 46).


Emelia Annum

Latest:

Breaking Down OHRP Assurances

This article will focus on specific requirements to ensure the Protection of Human Research Subjects (Title 45 CFR 46).


Jerome F. Pierson, PhD

Latest:

Breaking Down OHRP Assurances

This article will focus on specific requirements to ensure the Protection of Human Research Subjects (Title 45 CFR 46).


Shelly M. Simpson

Latest:

Breaking Down OHRP Assurances

This article will focus on specific requirements to ensure the Protection of Human Research Subjects (Title 45 CFR 46).


Rob Sambrook

Latest:

Optimizing Study Design in Real-World Evidence Generation

With outcomes from “real life” a critical compliment to clinical trial data, the importance of involving an epidemiologist at study inception is explored.



Ranjeet Gutte

Latest:

Weighing the Benefits of RBM Implementation

Case study demonstrates how one global mid-sized sponsor is testing the RBM waters.


Craig Morgan

Latest:

Analytics and Metrics Help Pinpoint Costs of Study Start-Up

Using data analytics to introduce parallel processes to optimize and accelerate clinical trials.


Angela Radcliffe

Latest:

Five Trends in Clinical Trials We’ll See in 2019

Right now, we only seek “perfect patients” for our trials, rendering many drugs potentially less safe or effective for those in demographics the study was not designed for.


Stephen A. Sonstein, PhD

Latest:

Moving From Compliance to Competency: A Harmonized Core Competency Framework for the Clinical Research Professional

Medicines development and clinical research are among the most heavily regulated activities on a global basis.




Dan Riskin

Latest:

Real-World Evidence Studies can Enhance Diversity and Equity in Clinical Research

Randomized controlled trials establish strict inclusion and exclusion criteria in an effort to optimize the cohort of trial participants.


Mark Lambrecht

Latest:

Overcoming the Pitfalls of Using Real-World Evidence in Regulatory Submissions

Utilizing a broad network of provider sites is key in overcoming failure and enabling access to high quality data.


Mukhtar Ahmed

Latest:

Clinical Development…In a Perfect World

Life sciences organizations run a challenging gauntlet when it comes to clinical development.



Frank Pétavy

Latest:

Global Standardization of Clinical Research Data

Outlining the latest government, industry, and public health efforts to promote increased adoption of common standards in data collection and sharing.


Nathalie Seigneuret

Latest:

Global Standardization of Clinical Research Data

Outlining the latest government, industry, and public health efforts to promote increased adoption of common standards in data collection and sharing.


Lynn D. Hudson

Latest:

Global Standardization of Clinical Research Data

Outlining the latest government, industry, and public health efforts to promote increased adoption of common standards in data collection and sharing.


Barbara Jauregui

Latest:

Global Standardization of Clinical Research Data

Outlining the latest government, industry, and public health efforts to promote increased adoption of common standards in data collection and sharing.


Lauren B. Becnel

Latest:

Global Standardization of Clinical Research Data

Outlining the latest government, industry, and public health efforts to promote increased adoption of common standards in data collection and sharing.


Jose Galvez

Latest:

Global Standardization of Clinical Research Data

Outlining the latest government, industry, and public health efforts to promote increased adoption of common standards in data collection and sharing.


Tammy Jackson

Latest:

Global Standardization of Clinical Research Data

Outlining the latest government, industry, and public health efforts to promote increased adoption of common standards in data collection and sharing.


Rebecca D. Kush

Latest:

Global Standardization of Clinical Research Data

Outlining the latest government, industry, and public health efforts to promote increased adoption of common standards in data collection and sharing.


Nicole Harmon

Latest:

Global Standardization of Clinical Research Data

Outlining the latest government, industry, and public health efforts to promote increased adoption of common standards in data collection and sharing.


Fang Liz Zhou

Latest:

Global Standardization of Clinical Research Data

Outlining the latest government, industry, and public health efforts to promote increased adoption of common standards in data collection and sharing.


James K. Malone

Latest:

Global Standardization of Clinical Research Data

Outlining the latest government, industry, and public health efforts to promote increased adoption of common standards in data collection and sharing.


Eileen Navarro Almario

Latest:

Global Standardization of Clinical Research Data

Outlining the latest government, industry, and public health efforts to promote increased adoption of common standards in data collection and sharing.


Ronald Fitzmartin

Latest:

Global Standardization of Clinical Research Data

Outlining the latest government, industry, and public health efforts to promote increased adoption of common standards in data collection and sharing.

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