Authors


Megan Trost

Latest:

Addressing the Needs of Clinical Trial Sites in a Post-COVID-19 World

Recognizing pre-pandemic pain points, such as patient engagement and protocol development, could lead to post-pandemic trial success.


Dr. Mwango Kashoki, MD, MPH

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.


Enno Behrendt

Latest:

Targeting Patient Population

Keys to ensuring your clinical trials better reflect your target population.


Adelina Paunescu, PhD

Latest:

Budgets and Billing in Clinical Trials: DCT Considerations

Cost strategies for medical device trials in the new era of digital health.


Elisa Mansfield

Latest:

Implementing a Gold Standard FSP Strategic Partnership

Use case explores the arrangement’s effectiveness in the biometrics setting.


Inteliquet

Latest:

Precision Medicine in Clinical Trials: Adapting to the New Demands of Clinical Research Today

Webinar Date/Time: Thursday, May 25th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST


Livia Tran

Latest:

De-Risking Trials with Science-Driven Oversight

Identifying the ‘significant six’ areas of clinical study conduct to mitigate risk.



Prashant Chaturvedi

Latest:

AI/ML Approaches to Assisted Medical Writing—Part 2

Following a discussion around summarization in Part 1, Part 2 discusses the method of pure abstraction in light of recent advances in deep learning and AI.


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.


Bhavish Lekh

Latest:

Beyond the Horizon: A New Era for Faster, Smarter Clinical Trials

Current industry trends align with the need for improved, fit for purpose technology.


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.


Archana Hegde

Latest:

How AI and Regulation are Reshaping the Future of Drug Safety

Balancing the emerging benefits of AI in pharmacovigilance with new responsibilities and demands from regulators in enhancing efficiency and safety.


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?

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