Authors


Craig McLendon

Latest:

DMCs: Maintaining Data Integrity in COVID-19 Climate

Regulators are urging the use of data monitoring committees to support clinical trial management and decision-making during pandemic.


Francis Pollaro

Latest:

Q&A With Daniel Lofaso, CEO of Digital Elevator

In this Q&A with Applied Clinical Trials' sister brand, Pharmaceutical Executive, Lofaso discusses marketing strategies for early-stage biotech companies, including how they can effectively recruit patients for their clinical trials.


Chuck Drucker

Latest:

At-home Self-collection of Blood Specimens for Safety Lab Testing in Clinical Trials via the Tasso+ Device

Laboratory services organization focuses on easing patient and site burden with improved collection device.


Luk Arbuckle

Latest:

Establishing a Basis for Secondary Use Standards for Clinical Trials

Study seeks to understand how different forms of data meet the needs of researchers.


Anthony Everhart, MD

Latest:

Optimal COA Measurement Strategy in Modern Oncology Trials

Examining the two areas of weakness cited in FDA draft guidance.


Patricia Davidson

Latest:

Introducing PALADIN

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


Nurul Atiqah Binti Abd Rahman

Latest:

Managing Clinical Trial Agreements

How Clinical Research Malaysia sped up CTA turnaround using a web-based system.


Jai Seth

Latest:

Getting to Clinical Trial Diversity

Differing levels of trust in clinical trials information channels across diverse populations is examined in this research.


Leslie Pascaud

Latest:

Creating Future-Ready Teams for Digital Clinical Trials

The need for specific capabilities to suit DCT business models is creating new challenges in team building, training, and development.


Ann Neuer

Latest:

Revamping Site Feasibility as Trials Become Decentralized

How asking better questions and leveraging site databases can expand access to more patients.


Science 37

Latest:

How to Operationalize Infectious Disease Trials with a Virtual Site

In this playbook, learn how a virtual site solution expands access to infectious disease clinical trials by allowing patients to enroll and participate from anywhere.


Yong Li Fern

Latest:

The ICR-CRM-IQVIA Research Network Collaboration Experience

A discussion of the impact of a strategic alliance in to facilitate operational success at the clinical trial site level in Malaysia.


Mikael Forsby

Latest:

eSource Interoperability Between EHR and EDC

Evidence from a Phase III cancer trial points to notable advances in data-transfer tech.


Joy Y. Wu

Latest:

Pandemic Challenges and Opportunities for Gender Equity in Clinical Research

Industry must act now to minimize effects of COVID-19 on clinical research.


Mats Sundgren, PhD

Latest:

eSource Interoperability Between EHR and EDC

Evidence from a Phase III cancer trial points to notable advances in data-transfer tech.


Derk Arts

Latest:

Debunking Top 5 Myths about Digital Twins in Clinical Trials

Addressing misconceptions as industry becomes more familiar with AI and ML.


Noelle Clifford

Latest:

Microbiology is Vital to Compliance to Annex 1 and Risk-Based Regulation

The revision of Annex 1 clearly calls out the use of quality risk management to identify potential risks to quality and the implementation of a contamination control strategy.


Pete Tarasov

Latest:

6 Steps During Pandemic to Support the Needs of Patients and Sites

The latest FDA and EMA guidelines permit sites, sponsors, and CROs to adjust their operations to meet changing conditions for ongoing trials, including some concerning the safety of participants, that must be met in order for new solutions to be considered.


Natalia Muhlemann

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.



Nadir Ammour, MBA, DMD

Latest:

Innovations in Data Capture Transforming Trial Delivery

Advances in technology open door for improved EHR to EDC transfer process.


Aswin Chandrakantan

Latest:

Navigating Clinical Trial Recruitment in the Midst of COVID-19

Many companies during this time of social distancing have paused trial recruitment completely to focus on currently recruited patients, while others rethink their strategy to better accommodate the new digital-only reality.


Amandine Manon, PharmD

Latest:

FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug Developers

January 2023 guidance from FDA on dosages in oncology provides further context on expectations with Project Optimus.


Elisabeth Coart, PhD

Latest:

Integration of Biomarker Validation in Oncology Trials

Recent case study highlights the importance of applying statistical rigor throughout the development and validation processes of biomarkers.


Chris Ingram, Bsc (Hons)

Latest:

Evolution of the UK Legislative Framework for Clinical Trials

New proposals aim to create higher standards for trial regulation.


Michael G. Kelly, PhD

Latest:

Rare Disease Clinical Trials: Strategies Learned from Duchenne Muscular Dystrophy

Approaches sponsors, CROs, and investigators can take from the DMD experience.



Max Luccock

Latest:

Survey Results: GCP Quality and Risks in Decentralized Clinical Trials

Identifying and providing clarity on the GCP quality and risk concerns associated with DCT modalities.


Mac Winslow

Latest:

Considerations to Reach Underrepresented Groups

Regulatory compliance, collaboration, and effective use of technology among ways CROs can overcome challenges.


Brandy Morneau

Latest:

How to Navigate the Clinical Trial Complexities in a Post-COVID World

With various COVID-19 vaccine trials underway, a seamless clinical research process has never been more critical.

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