Authors


Lynne Hughes, PhD

Latest:

Mitigating Risk in Implementing Multi-Regional Trials in MS

Examining the main challenges in designing and executing MS clinical trials and proposing mitigation strategies that may help alleviate these burdens.


Cathy Vanbelle

Latest:

Mitigating Risk in Implementing Multi-Regional Trials in MS

Examining the main challenges in designing and executing MS clinical trials and proposing mitigation strategies that may help alleviate these burdens.


Olja Tanjga, MD

Latest:

Mitigating Risk in Implementing Multi-Regional Trials in MS

Examining the main challenges in designing and executing MS clinical trials and proposing mitigation strategies that may help alleviate these burdens.


David Akirtava, PhD

Latest:

Understanding the Investigator Usage of Individual Pharmaceutical Companies; the Pfizer Case

With Open Payments it is possible for Pfizer to better understand its own investigator usage pattern and how that pattern may differ from the practices of other pharmaceutical companies.



Donatas Grina

Latest:

Clinical Trials in the Baltic States

The region has an appropriate population size, solid infrastructure, experienced nvestigators, and short timelines.


Karen Correa, PhD

Latest:

Enrollment Cycle Times Can and Should Be Optimized

Case study shows that site activation is a key driver in determining patient enrollment cycle time, which can be minimized by identifying the "sweet spot" of sites to deploy for a clinical trial.


Jonathan Peachey

Latest:

A Digital Twin on CAR-T Cytokine Release Syndrome (CRS) Patients with Standard of Care Measured by CRS Distribution by Grade

Using existing clinical trial data to proactively model patient safety and efficacy outcomes could aid in accelerating development for areas in need of new therapies.


Valerie Legagneur

Latest:

Enrollment Cycle Times Can and Should Be Optimized

Case study shows that site activation is a key driver in determining patient enrollment cycle time, which can be minimized by identifying the "sweet spot" of sites to deploy for a clinical trial.


Rabinder Buttar

Latest:

Build Trust with Honesty and Communication

The importance of openness and loyalty cannot be overlooked when cultivating a parternship.


Cathleen Dohrn, PhD

Latest:

Challenges Emerge from Low NASH Awareness

Addressing the current hurdles and potential solutions in nonalcoholic steatohepatitis awareness and clinical trial enrollment.


Nicole C. Woitowich, PhD

Latest:

Considering Sex as a Variable in Clinical Trials

A sex-bias that significantly impacts the advancement of women’s health exists in both preclinical and clinical research.


Andrew Griffiths

Latest:

Revolutionizing Clinical Trials Through Real-Time Data Capture and Analytics

This article discusses real-time data capture and analytics in clinical trials.


James P Angus

Latest:

Revolutionizing Clinical Trials Through Real-Time Data Capture and Analytics

This article discusses real-time data capture and analytics in clinical trials.


Andy N Brown

Latest:

Revolutionizing Clinical Trials Through Real-Time Data Capture and Analytics

This article discusses real-time data capture and analytics in clinical trials.





Lee Horner

Latest:

Value of Virtual Care Technology in Clinical Trials

Virtual care technology is emerging as a valuable tool for clinical trials, helping to improve recruiting and strengthen retention while optimizing resources for the overall study.



Julie Schulman

Latest:

Models of Engagement: Patients as Partners in Clinical Research

Exploring three distinct patient partnership models to help researchers assess which methods of engagement could work best for their clinical programs.


Kirk Jernigan

Latest:

Models of Engagement: Patients as Partners in Clinical Research

Exploring three distinct patient partnership models to help researchers assess which methods of engagement could work best for their clinical programs.


Patty McAdams

Latest:

Models of Engagement: Patients as Partners in Clinical Research

Exploring three distinct patient partnership models to help researchers assess which methods of engagement could work best for their clinical programs.


Lindsay Singler

Latest:

Models of Engagement: Patients as Partners in Clinical Research

Exploring three distinct patient partnership models to help researchers assess which methods of engagement could work best for their clinical programs.


Kathleen Sanzo

Latest:

FDA Issues Final Rule on Data Acceptance from Clinical Investigations for Medical Devices

The FDA published a final rule on FDA’s standards for accepting data from clinical investigations for medical devices on February 21.


Michele L. Buenafe

Latest:

What Pharma Companies Need to Know About FDA's New Draft IVD Guidance

The FDA's new draft IVD Guidelines will need to be factored into how pharma clinical trial sponsors use IVDs in a clinical trial, study design, timeline for protocol development, IND submission, and study initiation.


Nimita Limaye, PhD

Latest:

A Roadmap for Implementing RBM and Quality Management

The importance of applying change management techniques throughout the preparation, planning, and execution of RBM and RBQM approaches.


Awani Saraogi

Latest:

How Social Media is Transforming Pharma and Healthcare

Outlining the growing attention and pursuits around social media in adverse event reporting and advancing patient-centric initiatives in clinical trials.   


Robert Collins

Latest:

Making Real-World Evidence Real

An expert view on how sponsors can formalize the use of real-world data and generation of real-world evidence to drive critical insights.


Annick Anderson

Latest:

Trends in Global Public and Patient Perceptions of Clinical Research

To inform our understanding of public and patient trust and confidence, this article provides a high-level summary of the results of two studies monitoring trends in international public and patient attitudes and perceptions.

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