Authors



Sailesh K. Patel

Latest:

R&D Using the Metaverse and Digital Twins

How the digital environment can transform drug development space.


PurpleLab

Latest:

PurpleLab Accelerates Clinical Trial Lifecycle with Real-World-Data

Jason Gagner (Vice President of Product for Life Science, PurpleLab) talks about clinical trial variables and how PurpleLab is working to maintain patient retention and accelerate site feasibility.


Sarah Kosta, PhD

Latest:

Enhancing Empowerment in Patient-Focused Research

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


Julia Oddy

Latest:

Tailored Patient Involvement in Clinical Trials

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


Christine Moore, PhD

Latest:

Why and How to Infuse Methodological Rigor into Psychedelic Clinical Trials

Renewed interest in psychedelic research shows great promise for patients in need of more effective therapies.


Verily

Latest:

Transforming Healthcare Data

We are amidst a data revolution in healthcare and the life sciences. With advances in DNA sequencing, multiomics, wearables, imaging, and clinical data capture, there is more data — and there are more data modalities — to draw from for biomedical research than ever before. However, the quantity, variance and speed of data generation outpaces researchers’ ability to effectively utilize it to reveal medical breakthroughs for those in need. The ability to analyze health data is critical in developing a precision health approach. By leveraging diverse data sources, researchers can determine the most effective actions for individuals and communities. However, current barriers to data access and collaboration hinder progress. To accelerate the pace of discovery, a solution is needed to close the gap between research and health care. This paper describes how Verily Workbench provides solutions for healthcare professionals and researchers to easily access and collaborate on data within an integrated analysis and governance framework. Workbench provides a community of researchers with the platform, data, and tools to solve the most pressing scientific challenge


Mary Jo Lamberti, PhD; Abigail Dirks, MS; Nicholas Kikuchi; Neha Patel Cervantes; Ken Getz, MBA

Latest:

An Examination of the Use of Patient Recruitment and Retention Tactics for Global Studies

In light of scant published data from sponsors and contract research organizations on site activation and recruitment challenges following the COVID-19 pandemic, the primary objective of this research is to revisit the results of recruitment and retention tactics in studies conducted in 2012 and 2019.


Mignon Loh, MD

Latest:

Patient-Tested Practices for In-Home Trials

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


Ingrid Oakley-Girvan, PhD

Latest:

The Powerful Impact of Caregivers on Clinical Trials

Considering caregiver-supported trials to improve patient retention and outcomes.


Jennifer Kamara

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.


Dan Beaudry

Latest:

The Eradication of False Signals in Monitoring

How optimizing RBQM risk detection reduces the efforts caused by false signals.


Heidi Nai Soraya Roslan

Latest:

Managing Clinical Trial Agreements

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


Bruce Miller

Latest:

Introducing PALADIN

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


Bhavish Lekh and Ola Gudmundsen

Latest:

Industry Perspectives on the Key Challenges in Trial Optimization

For advancement, pharma must focus on streamlining clinical operations.


Jessica Robin

Latest:

How Speech-Based Digital Biomarkers are Redefining the Measurement of Disease Progression in Neurodegenerative Dementia Trials

Future shows great potential for neurological language assessments in clinical trials.


Andrea Zobel

Latest:

Direct-to-Patient: At-Home Clinical Trials Are Here to Stay

The success of the decentralized model hinges on coordination between stakeholders across the supply chain to ensure that date is secure, medication is delivered on time, and in proper condition.



Noah Gottlieb

Latest:

Investigative Site Placement Practices to Support Operation Warp Speed

Comparing late-stage COVID-19 vaccine trials to historical practices.



OneStudy

Latest:

Strategies to Fill Gaps in Patient Recruitment and Enrollment eBook

The patient recruitment and enrollment funnel is an overlooked pain point in clinical research. OneStudyTeam addresses inefficiencies in this stage, along with opportunities and strategies for improvement.


Alice Agnew

Latest:

Navigating New Changes During the Pandemic

COVID-19 reshaping the roles of CRAs overseas as industry shifts to remote monitoring.


Stuart Cotter

Latest:

The Latest Advancements in Single Sign-On Technology

How today’s SSO reduces site burden and spearheads clinical system interoperability.


Peter Mesenbrink

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.


WCG

Latest:

The Nuances of Patient Selection: Why Some Trials Need Eligibility Adjudication

Patient selection can be a nuanced process in clinical trials, particularly those involving therapeutic areas with more complex or subjective inclusion/exclusion criteria. Determining patient eligibility may often depend on factors that require clinical expertise in such areas as disease progression, comorbidities, genetic mutations, and disease severity. Discover the role eligibility adjudication committees play in ensuring trial success.


Jeffrey J. Stoddard, MD

Latest:

Balancing the Three-Legged Stool

REMS are new only in name. The basic concept has long been central to drug regulation.


Brad Anderson

Latest:

Top 5 Mistakes of RFP Writing

Knowing what you want from a CROs proposal will help make the most of the selection process.


Harold E. Glass

Latest:

Key Factors in CRO Selection

A recent survey uncovers key criteria that influence a sponsor's decision when selecting a CRO.


Dave Scott

Latest:

Outsourcing's Evolution from Commodity to Partner

Can the historical industry and vendor service relationship change to one where both parties benefit?


Daniel P. Beaudry

Latest:

Key Factors in CRO Selection

A recent survey uncovers key criteria that influence a sponsor's decision when selecting a CRO.

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