Authors


Devendra Raj, PhD

Latest:

Global Regulatory Publishing Trends

A review of submission formats for drug development.



Richard Yeatman

Latest:

eSource Interoperability Between EHR and EDC

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


Tinaya Gray

Latest:

Seeking Solutions for More Representative Populations

Exploring a human-centered, holistic approach for equitable trial outcomes.


Rakhi Kilaru

Latest:

Harnessing the Power of Scientific Surveillance

Statistical methods used via this technique in centralized monitoring.


Mabel Crescioni

Latest:

Demystifying Submissions of eCOA Documentation for Ethics Review: Are We Making Submissions More Difficult than Necessary?

Examining how to optimizing the time and effort of Ethics Committees to efficiently and effectively fulfill their human subjects protection remit.


Kelly FitzGerald, PhD, CIP

Latest:

Optimizing Technology Implementation to Improve Diversity in Clinical Research

Three key considerations for deploying technology to help increase diversity in trials.


Narinder Chopra

Latest:

Understanding the Complexities of Diversifying Clinical Trials

Tufts Center for the Study of Drug Development and Biogen recently conducted a study to inform growing interest in improving diversity of clinical trial participation. The results of this research provide insights into increasing the community of minority investigators and study staff and presenting greater access to clinical trials among minority study volunteers.


Gretchen P. Jackson, MD, PhD

Latest:

Accelerating Clinical Trial Design and Operations

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


Sandra Smyth

Latest:

Towards Data-Driven Clinical Trial Planning and Strategy

Optimizing feasibility through increased data collection.


Meg Richards, PhD

Latest:

How Life Sciences Companies Can Strengthen Regulatory Submissions With External Control Arms

Data from past clinical trials has provided researchers with a good starting point to create more ECAs.


Tim Rich

Latest:

Decentralized Clinical Trials Bring Research to the Patient—in More Ways Than One

DCTs proving to solve numerous pain points for patients in clinical research.


Ken McCann, DO, CIP

Latest:

Optimizing Technology Implementation to Improve Diversity in Clinical Research

Three key considerations for deploying technology to help increase diversity in trials.


Elizabeth Kelchner

Latest:

Tips to Rescue a Clinical Trial Before It’s Too Late

Why constant communication and transparency are paramount to successful partnerships between pharmaceutical companies and CROs


Ashley George

Latest:

Virtual Clinical Trials Post-COVID-19: Collaboration Will Be Key to Success

The use of virtual trials will surge in the future and could become the de facto standard for clinical studies, says a recent Pistoia Alliance poll.


Anna Pinsky, MD, PhD

Latest:

The EU Regulations Catching US Pharma Companies Off Guard

Companies that understand the regulatory environment in Europe can keep their trials on budget and on schedule.


Jeff Policastro

Latest:

Changing the Paradigm in AI Implementation

How pharma companies can reduce the risk of failure with AI-based innovations.


Warren Stacey

Latest:

Putting Labeling on the Boardroom Agenda

How smart packaging can aid clinical trial adherence.


ZS Associates

Latest:

Using Clinical Trial Sites' Input to Select the Right Capabilities when Decentralizing Clinical Trials

This paper analyses the responses from more than 800 US-based clinical trial sites to understand their decentralized clinical trial capabilities and perceptions


Arnab Roy

Latest:

Adapting Site Selection for Clinical Trial Decentralization and the Future Landscape

Sites not expected to fade away even as DCTs continue to grow past COVID-19.


Robin Heiskell

Latest:

How Clinical Trial Research Sites Can Gain Access to a More Level Playing Field

To overcome sponsor-related challenges and work to successfully secure more trials, there are tactical steps CROs can take.


Dassault Systems

Latest:

Modernizing Data Management in the D-Clinical Age

***Live: December 9, 2020, at 11am EST| 8am PST| 4pm GMT| 5pm CET*** In this ‘D-Clinical Age’, leveraging modern technologies and new approaches and mind sets is required to accelerate the development of new treatments. This webinar will examine how data management can drive digital transformation with the right mix of technology, skills and process redesign.***On demand available after airing until Dec. 9, 2021.***


Olivier Chassany

Latest:

Demystifying Submissions of eCOA Documentation for Ethics Review: Are We Making Submissions More Difficult than Necessary?

Examining how to optimizing the time and effort of Ethics Committees to efficiently and effectively fulfill their human subjects protection remit.


Mark Dudley, PhD

Latest:

Designing Cell Therapies to Target Solid Tumors

A look at one company’s platform approach in enabling the engineering of T-cells to identify and destroy cancer.


Nicholas Saraceno

Latest:

Datopotamab Deruxtecan Biologics License Application Accepted by FDA for NSCLC Based on Phase III Trial Data

Datopotamab deruxtecan, the first TROP2-directed DXd antibody drug conjugate, is being evaluated for locally advanced or metastatic nonsquamous non-small cell lung cancer.


Karl Landert

Latest:

Considerations for the Effective Rollout of DCTs at a Global Scale

For effective rollout on a global scale, sponsors must address and develop a plan around known challenges including recruitment, sit adoption, and technology integration.



Joseph Constance

Latest:

Regulatory Data: How Technology Can Help ClinOps Survive

Clinical operations professionals, burdened by lack of data standardization, turn to technology in hopes of streamlining regulatory processes for the future.


UBC

Latest:

Guide to Incorporating Modern Research Tools and Techniques

This piece offers a practical assessment of leveraging various decentralized methodologies and technologies.


Fan Gao, PhD, MS

Latest:

Adapting Site Selection for Clinical Trial Decentralization and the Future Landscape

Sites not expected to fade away even as DCTs continue to grow past COVID-19.

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