Authors


Julian Upton

Latest:

Engaging with Emotions: Patients as Partners

Involving patients more meaningfully in the industry's activities means getting more serious about their emotional wellbeing.


Irv Cantor

Latest:

The Quality Coach

The right person can successfully promote proper management of quality and compliance, leading to desired clinical trial outcomes.


Emma Waite

Latest:

Biomarker Boom

A look at the different testing methods and how the results impact drug development.


Kenneth Getz, MBA

Latest:

Introducing PALADIN

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


Christy Chuang-Stein

Latest:

Adaptive Designs: A Fad or the Future of Clinical Research?

Making adaptations to clinical trials in the early stages of research with the use of interim data.


Friedbert Theis, PhD

Latest:

Critical Appraisal of Clinical Quality Assurance Based on Benchmarking Results: Past - Present - Future

A follow-up survey on clinical quality assurance (CQA) assesses current industry best practices compared to a decade ago, and provides recommendations on this key component of quality management for the future.


Richard Irons

Latest:

East vs West

How cultural and training differences affect molecular-based clinical research in China.


Ed Tourtellotte

Latest:

Three Generations of RTSM (Randomization and Trial Supply Management)

With all the focus on various data capture solutions in the clinical trials world over the past decade(s), few people seem to have noticed the exponential advances made in the real workhorse systems of the trials: RTSM. Also known as IVR, IWR and IRT, these systems actually execute randomization, blinded supply and resupply management to depots and sites, and most importantly of all, drug dispensing. Is there anything more important to get right?


Carl-Fredrik Burman

Latest:

Adaptive Designs: A Fad or the Future of Clinical Research?

Making adaptations to clinical trials in the early stages of research with the use of interim data.


Beatriz Mosqueira

Latest:

Approaching Africa

The Declaration of Helsinki requires that control groups receive the “best” current treatment, not the “local” one. This shift in wording has profound implications.


Paul Nowacki

Latest:

Pharma Casts Out Financial Functions

Outsourcing finance and accounting can provide cost savings and improve operations.



Jasmin Khan-Boluki

Latest:

Pediatric Research in Germany

Surveys among pharma, clinics, and investigators shed light on trials in children.



Igor Stefanov

Latest:

Risk Based Budgeting

Adoption of the concept of Risk-Based Budgeting could help maintain the trial budget or even save the whole clinical trial.


Jane Reed, director, life sciences NLP, IQVIA

Latest:

How NLP Surfaces Adverse Events and Safety Insights to Improve Drug Safety Processes

Use cases show benefits of unlocking data to improve signal and adverse event detection.


Christian Olsen

Latest:

Three Must-Dos for Tracking Research and Development of Monoclonal Antibodies

There is an expanding array of potential antibody-based treatment options, such as bispecific or multispecific antibodies, that show promise in addressing conditions such as cancer, engineered antibody fragments, or even antibody-drug conjugates.


Andrew Hartley, PhD

Latest:

Harnessing the Power of Scientific Surveillance

Statistical methods used via this technique in centralized monitoring.


Kelly Dumais, PhD

Latest:

Considering Patient Burden in Oncology

Implementing new strategies with the use of patient-reported outcomes.


Alena Galante

Latest:

Virtual Medical Affairs Audits: A Viable Alternative

Virtual audits proving to be beneficial post-COVID despite continuing challenges.


Panteli Theocharous

Latest:

Facilitating Adoptive Cell Therapy Clinical Trials

Evolving technologies include modification of receptors on T cells to better target tumor microenvironments and minimize off-tumor cross-reactivity.


Estelle Haenel, PharmD, PhD

Latest:

eCOA Studies: Tackling the Barriers to Adopting ‘Bring Your Own Device’ Strategies

An increasing number of patients report looking for more simplicity and less burden related to a clinical trial, and a "bring your own device" option is one of the ways to meet this need


Kristel Van de Voorde

Latest:

Clinical Study Audits: The Quality Management Approach

Advancing risk-based auditing one step further by identifying the underlying process deficiencies to enable improved corrective and preventive actions.



Peter Madrid

Latest:

Bringing AI Out of the Shadows and into the Physical World of Drug Development

While many groups rely on manual chemistry processes, innovative platforms have emerged that allow these protocols to be executed on custom automation systems.


Don Tracy, Associate Editor

Latest:

The Use of Artificial Intelligence in Clinical Trial Enrollment

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Sonia Lwoff, director, clinical operations, Rho, discusses the potential for artificial intelligence in clinical trial decision-making and enrollment.


Fiona Thistlethwaite

Latest:

Facilitating Adoptive Cell Therapy Clinical Trials

Evolving technologies include modification of receptors on T cells to better target tumor microenvironments and minimize off-tumor cross-reactivity.


Donato Bonifazi

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.



Vineti

Latest:

Preparing for Pivotal: Solving Challenges in Scale for Cell and Gene Therapy Clinical Trials

Tuesday, June 22, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST

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