Authors


endpoint Clinical

Latest:

Case Study: Successful System Integration for Decentralized Clinical Trials endpoint Clinical and THREAD’s Solution Ensures the Successful Flow of eConsent Data

Today’s clinical studies are increasingly complex and require patient-centric trial designs, like decentralized trials, more than ever before. As trials incorporate more decentralized components there is an ever-present need for multiple system integrations to support the various trial functions, with the goal being that all trial data flows seamlessly between systems and is stored in one repository for efficient oversight and analysis. These numerous integrated systems require closely managed integration, synchronization, and supportive partnerships to minimize error and maximize efficiency. In this case study, partners endpoint and THREAD dig-in to explore how IRT can be integrated with decentralized clinical trial (DCT) technology, working through tightly integrated workflows, to provide a streamlined process, a better user experience for Sites and Participants, higher quality data and real-time access to information.


Rohit Kadam

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.



Tamie Joeckel

Latest:

Best Practices in Managing CGT From Protocol Design to Data Management

Though the fields of immunotherapy and cell and gene therapies have seen significant growth since April 2012, CGT clinical research remains a challenge.




Andrea Bastek

Latest:

The State of the Clinical Trial Site Technology Industry: Examining Key Trends

Findings from Florence Healthcare’s State of Clinical Trial Technology Industry survey about how clinical operations technology changed in 2020 and how they expected it to evolve throughout this year.


Venu Mallarapu

Latest:

How Automation and Generative AI will Transform Clinical Trials in the Next 1-2 Years

DCTs, data, and analytics are all areas that could be impacted in the near future.


Kostja Paschalidis

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.


Philipp Hofmann, MD

Latest:

Spontaneous Reporting System for Adverse Drug Reactions in Germany

While underreported, ADR data offers significant value to the drug development value chain to refine the predictive capability and stability, and provide enhanced patient safety.


Malgorzata Michalak-Wojnowska

Latest:

Patient-Centered Recruitment and Retention

By decentralizing trials whenever feasible, sites can decrease patient burden, clinops workload, and the number of on-site participants.


Wai Keong Wong, PhD, FRCPath, MRCP

Latest:

eSource Interoperability Between EHR and EDC

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


Taylor Stucky

Latest:

AI to Impact Clinical Trials and Manufacturing in Life Sciences

Artificial intelligence may find a home in clinical trials and manufacturing in the coming years, but privacy, cyber security, and determining who owns the intellectual properties could pose challenges.


Sharon Duffy

Latest:

Navigating a Decentralized Trial Model and the Changing Clinical Landscape During COVID-19

A top-down analysis of the decentralized trial model’s benefits and impact on the industry.


Sergio Sánchez-Gambetta

Latest:

Where Innovation and Patients Meet to Improve Cancer Care

Promising scientific advances are pacing oncology drug development.


Şebnem Yaşaroğullari

Latest:

COVID-19 Pandemic Exemplifies the Benefits of CROs

The adaptability and innovative capacity of CROs highlighted in EUCROF survey.


Roya Sherafat, MD, PhD

Latest:

Enabling Evidence-Based Study Endpoint Selection

Harnessing advances in digital health technologies for a more precision-measured approach.


Lollo Eriksson, PhD

Latest:

Using Real-World Data in Patient Recruitment

Growing availability of RWD leads new drug development process.



Adam Dion

Latest:

COVID-19 and Its Impact on the Future of Clinical Trial Execution

Findings from a Tufts study examining the effects of COVID-19 on clinical trials.





Borje Darpo, M.D., Ph.D., Chief Scientific Officer, Cardiac Safety at Clario

Latest:

A pathway for replacing costly TQT studies

Bolstered by the recently approved S7B/E14 Q&A document, early-stage concentration-QTc analysis is emerging as a standard for assessing cardiac safety.


Anna Argyris

Latest:

Accelerating Research Site Operations

Lessons learned during the pandemic from University of Louisville.


David Rolando

Latest:

COVID-19 Pandemic Exemplifies the Benefits of CROs

The adaptability and innovative capacity of CROs highlighted in EUCROF survey.



Abby Sener

Latest:

The Argument for Data Alignment and Integration in Clinical Supply Management

Siloed systems can make it difficult to marry data to support timely and informed decision-making and optimize clinical trial operations.


Precision for Medicine

Latest:

Leveraging Lessons Learned From the First Decade of Modern Immuno-Oncology

Which new developments can help jump-start breakthroughs in immuno-oncology research? Understand the key scientific drivers, read peer-reviewed research, and get actionable ideas that can spur innovation in this must-read paper for clinical leaders.


Lars Behrend, PhD

Latest:

Consequences of Brexit for Clinical Trials in Europe

Higher costs headline list of new challenges faced by CROs and sponsors.

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