Authors


Amaury Jeandrain

Latest:

How Digital Twins are Driving Sustainability in Clinical Supply Planning

Emerging technologies like digital twins offer supply chain efficiency solutions, allowing the industry to integrate sustainable practices while ensuring patient safety.


Chase Carmeans

Latest:

3 Common eCOA Implementation Challenges and How to Solve Them

Overcoming hurdles with licensing complexities, post-production changes, and IRB submissions can help in reducing timelines and increasing collaboration.


Dr. Hilde Vanaken

Latest:

Smart New Normal in Medication Management—Personalized, Integrated, and Flexible

What the next generation medication management in clinical trials should entail and insights on smart technologies and synergistic partnerships—backed by real-life implementation use cases.


Caroline Redeker

Latest:

Optimizing Patient Recruitment and Engagement Strategies

Five strategies to reduce risk and achieve deadlines.


Ashish Indani

Latest:

Establishing Metrics and Standardization for Non-CRF Data in EDC

While Case Report Forms are a main contributor to collected data, non-CRF data such as core laboratory data and central imaging can be critical to any clinical study.


Edward Triebell

Latest:

A New Era in Clinical Trials

Industry challenges present an opportunity for innovation and the adoption of new solutions, particularly in addressing barriers related to patient recruitment, engagement, and retention.


Sirj Goswami, PhD, and Jason Rizzo, MBA

Latest:

Artificial Intelligence Drives Industry Response to Project Optimus

The FDA has taken a clear position with Project Optimus in shifting toward more progressive tailored approaches while rejecting antiquated study designs to evolve clinical trial strategies to better align with newer drug classes.


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.


Manny Vazquez

Latest:

Four Strategic Considerations to Choose an EDC

Companies share their experience in future-proofing clinical data technology.


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.


Jessa Boubker, Monica Chmielewski, Kyle Faget

Latest:

FDA Finalizes Decentralized Clinical Trial Guidance

The FDA's guidance is part of a broader effort to modernize clinical trials, improve efficiency, reduce participant burden, and expand access, particularly for underrepresented populations and those in geographically or economically constrained areas.


Noah Nasser

Latest:

Addressing Population Gaps in Therapy Adoption: Using Real-World Data to Bridge the Clinical Trial Divide

How clinical operations teams can close the gap between controlled trial results and real-world adoption by generating evidence in broader, more representative patient populations.

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