Authors


Estelle Ricoux

Latest:

The Future of Personalized Medicine Hinges on Revolutionizing Business Models

The era of big pharma as product-first companies must end, as services become the larger priority.


Julia Stepanchuk

Latest:

Trials During the Pandemic: A CRO's Perspective

Findings from an OCT Clinical survey of researchers from 61 sites in Russia to gain the perspective of an investigator regarding clinical trials during the COVID-19 pandemic.


Mariangela Lupo

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.


Datacubed Health 

Latest:

ROI of ePRO Use in Clinical Trials

The cost and benefits for patients and sponsors in using ePRO versus paper



Jules Mitchel, PhD

Latest:

When Should the Audit Trail Begin?

A discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.


Linda McCarty, JD, LLM

Latest:

The Time Is Now: Taxation Reform for Expanded Clinical Trial Access

Expanding clinical trial access to include historically underrepresented ethnic and racial minorities means addressing root-cause barriers, including taxation.


Kevin Potgieter

Latest:

Insight into the New ICH E6(R3) Draft Guidance on Clinical Trials

Decentralized clinical trials have the potential to expand the number of people who can benefit from clinical trials while accelerating therapies to more patients in need.


Jennifer Kim

Latest:

Examining the Impact of Exclusionary Behaviors on Team Dynamics

Tufts CSDD study finds that acts of microaggression negatively impact psychological safety and performance.


Andy Studna, Editor

Latest:

Creating a Framework for Increased Accessibility in Palliative Care Research

With inequalities in palliative care provisions, recent study seeks to create a more equitable, diverse, and inclusive framework based on Patient and Public Involvement.


Tony Clapsis

Latest:

Connection to Communities is Key to Boosting Clinical Trial Engagement

Tony Clapsis, SVP and General Manager, CVS Clinical Trial Services, reflects on industry’s progress.


Robert DiCicco

Latest:

Characterizing Clinical Data Management Challenges and Their Impact

2020 Tufts CSDD – IBM Watson Health benchmarking study highlights need for new functionality from EDC solutions and providers.


Miranda Schmalfuhs

Latest:

AI & Tech Use in Drug Discovery

Christian Olsen, VP, Industry Principal of Biologics at Dotmatics, discusses how artificial intelligence along with other technologies are being used to shorten the drug discovery funnel and reduce research costs.


Ana K. Christensen, MPH

Latest:

Rare Disease Clinical Trials: Strategies Learned from Duchenne Muscular Dystrophy

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


Joni Venticinque

Latest:

5 Ways DCTs Can Positively Impact Trial Diversity

COVID-19 forces life sciences industry to make long overdue changes.


Yaritza Peña

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.


Pantelis Vlachos

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.


Dr. Ashish Indani

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.


Betsy Wagner

Latest:

AI and ML are Transforming Clinical Research Practice

Three case studies showcase ability of AI and ML in overcoming challenges with data, resourcing, and more.


Jon Devries

Latest:

Trends in Radiopharmaceuticals That May Streamline Workflows, Optimize Efficiency

Ensuring equitable access to new technologies and integrating AI to benefit all communities remain critical challenges to overcome.


Nader Daoud

Latest:

Implications of the U.S. Supreme Court’s Affirmative Action Ruling for Clinical Research

If a future Supreme Court ruling on diversity were to be applicable to clinical research, the FDA’s positions on diversity will take on even more importance.


Sandra Orset, PhD

Latest:

Decentralized Clinical Trials: Being Audit Ready and Avoiding Pitfalls

Site and project management teams play major roles in risk-management and monitoring performance.


Marc Crawford

Latest:

How to Increase Engagement at Investigator Meetings

In new age of digital, investigators must carefully create strategies to keep engagement high.


Alexandra Lauré

Latest:

COVID-19: A New Era for Clinical Trial Research in Europe?

A look at the issues in Europe affecting ongoing trials including data management, measures being taken by sponsors, and more.


Subrata Bose

Latest:

The Only Thing Certain is the Uncertainty: How to Re-Plan Future Clinical Trial Enrollment in Covid-19 Times

Sponsors need to develop a strategy on how to evaluate the impact of the pandemic on the re-start of halted trials.


Ashley Pachter

Latest:

Tips and Tools to Overcome DE&I Challenges in Clinical Trials

Navigating FDA’s draft guidance and heightened diversity recommendations.


Mike Hennessy Jr.

Latest:

The Winds of Change

The evolving role of the CRA is creating shifts in the clinical workforce.


Patrick Campbell

Latest:

Advanced Hybrid Closed-Loop Technology Could Improve Quality of Life in Type 1 Diabetes

A 1-year observational follow-up of a 3-month RCT provides insight into he benefits of advanced hybrid closed-loop system use in people with type 1 diabetes using multiple daily injections and self-monitoring of blood glucose.


Nicolas Tsiakkas

Latest:

Use of Televisits in Studies and Related PV Concerns

While televisits can address many medical concerns, one frequent reservation expressed by healthcare professionals is that patients during these televisits tend to present too narrow a picture of their clinical condition-resulting in non-comprehensive medical assessments.


Samir Shah

Latest:

Anticipating Near-Term Structural Change in the Outsourcing Landscape

Can full-service outsourcing to CROs by large biopharma companies sustainably prosecute a clinical development portfolio?

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