Authors


Victoria Hunter

Latest:

Breathing New Life into Respiratory Clinical Trials with Digital Biomarkers

Increased data output from the use of devices can accelerate trials for this therapeutic area in need of new therapies.


Maggie Adamski 

Latest:

How to Measure Your Patient-Centric Impact

Practical suggestions for identifying what actionable insights have been impactful on clinical studies.


John Varaklis

Latest:

How Reverse-Engineering Clinical Trials to Leverage the AI-based-Digital Twin Solution Solves for Many Current Issues

These devices can help researchers identify data points that are not immediately available to researchers.


Gina DiCindio

Latest:

Accelerating Innovation Adoption to Support Drug Development Operations

Characterizing the long-term adoption experience of clinical technologies and capabilities—and what senior leaders can do to drive adoption within their walls.


Reaney M, Bruce R, Kelly K, Hughes L.

Latest:

Expanding Conceptual Model of Disease into Conceptual Model of Patient Experience for Designing, Interpreting Medication Effects

A three-part framework for a more comprehensive conceptual model of patient experience data can provide a more rounded understanding of patient experiences in clinical trials and beyond.


Dan Manak

Latest:

Modal Value Guided Clinical Trial Design Effectively Reduces Protocol Amendments

Analysis of 330,000 clinical trials calls for improved protocol design process.


Cristin MacDonald, PhD

Latest:

Accelerating Innovation Adoption to Support Drug Development Operations

Characterizing the long-term adoption experience of clinical technologies and capabilities—and what senior leaders can do to drive adoption within their walls.


Alan Kalton

Latest:

Fortifying Defenses Pre-Patent Cliff

Integrating artificial intelligence and advanced analytics throughout operations offers pharma companies a pathway to offset impending drug patent expirations.


Antoine Pironet, PhD

Latest:

Medication Adherence Monitoring and Management:A Closer Look at the Role of Data Science and Understanding Patient Behavior

The role of data science, how it can help us understand patient behavior, and why digital adherence solutions are the future.


Victoria DiBiaso

Latest:

Introducing PALADIN

First-of-its-kind consortium dedicated to accelerating new medicines development through optimizing patient advocacy group—industry collaboration.


Stefano Marini

Latest:

The Current Status of European Research Related to COVID-19: The EUCROF Perspective

Successful collaborations between Pharma/Biotech/Device industries and CROs will play a key role in an effective fight against the global COVID-19 pandemic.


Tom Mann

Latest:

Enhancing Empowerment in Patient-Focused Research

How the inclusion of measures centered on net treatment benefit can drive an effective multifaceted approach.


Sharad Sharma

Latest:

Establishing Metrics and Standardization for Non-CRF Data in EDC

While Case Report Forms are a main contributor to collected data, non-CRF data such as core laboratory data and central imaging can be critical to any clinical study.


Dr. Steve Winitsky, MD

Latest:

Effective regulatory strategies for rare disease

In the rare disease issue of New Medicines, Novel Insights from Parexel, experts and former regulators share insights for developing effective regulatory strategies earlier.


Apurva Bhingare

Latest:

Employing the Power of Bayesian Methods to Expedite Learning

Bayesian methods bring flexibility and speed to clinical trial design and analysis, and with increased access to the necessary computational power, are transforming today’s clinical research.


Derk Arts, MD, PhD

Latest:

How Pharma Needs to Prepare for the Next Pandemic

Master protocols helped accelerate research during the pandemic in the EU. How can US companies learn from this and start preparing master protocols now?


Kathleen Killen

Latest:

Tailored Patient Involvement in Clinical Trials

The approach of the Cancer Research UK Centre for Drug Development.


James Moat

Latest:

The Evolution of CRO and Sponsor Relationships

Exploring the 11 key ‘warning signs’ that could impact partnership success.


Tony Carita

Latest:

A New Approach to Risk Balanced Contracting

In a complex world of global clinical trials where execution is riddled with uncertainty, how should sponsors and providers approach and achieve a balance of risk and reward?


Serge Bodart, MS

Latest:

Integrating Technology and Expertise

Phase I/II study in cancer patients showcases eClinical effectiveness.


Ryad Ramda, MS

Latest:

Accelerating Clinical Trial Design and Operations

Fully-integrated, component-based CDMS offers flexibility, customization, and efficiency.


Hugo Geerts, PhD

Latest:

Upping the Ante for Predicting the Success of Alzheimer Disease Treatments

The use of modeling and biosimulation can help predict potential outcomes and improve confidence in therapeutic candidates for Alzheimer disease.


Nicole Palmer

Latest:

10 Questions to Consider With eTMF Vendor Selection

The many different shapes and sizes of vendors requires a thoughtful process for selection.


Matthew Ryan

Latest:

Unleashing Their Potential: The Evolving Landscape of DHTs

Key considerations in deploying fit-for-purpose digital health technologies in drug development.


Navjot Kaur, PhD

Latest:

Managing Biospecimens in Cell and Gene Therapy Trials

Pursuing new tools and capabilities in sample logistics, storage, and data analysis.


Mike Straus

Latest:

Patient Recruitment Goes High-Tech

Emerging tools in data analytics, automation, EMR aggregation, and even social media are enabling faster and easier patient recruitment.


Lamine Mahi

Latest:

COVID-19 Pandemic Exemplifies the Benefits of CROs

The adaptability and innovative capacity of CROs highlighted in EUCROF survey.



Marc Rothman, MD

Latest:

Patient-Tested Practices for In-Home Trials

Bringing clinical trials to patients’ homes can address existing site-based challenges.


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