Authors


Saurabh Das

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.


Esther Mahillo

Latest:

Enhancing Enrollment in Biomarker-Driven Oncology and Rare Disease Trials

Integrated approaches can help enhance recruitment plans.


Nausheen Saleem

Latest:

eSource Interoperability Between EHR and EDC

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


Rohini Kumar

Latest:

Ten Considerations for Sensor Selection in Clinical Trials

The careful selection of sensor technology prioritized in clinical trials, considering regulatory compliance, data security, device characteristics, and the specific needs of the trials for successful and confident implementation.


Meg Rivers

Latest:

From Physician to Pharma: Gynecologic Oncologist Enters Clinical Trials Space

In an interview with Applied Clinical Trials' sister publication, Pharmaceutical Executive, Elizabeth (Beth) Garner, chief scientific officer for Ferring Pharmaceuticals, discusses what it was like transitioning from working as a gynecologic oncologist and seeing patients to working in pharma, specifically clinical trials.


Ramona Walls

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.


Robert Paarlberg

Latest:

Clinical Trial Disclosure and Data Transparency: Obligation or Opportunity?

Implementing disclosure and data transparency policies and procedures represents an opportunity for sponsors, rather than an obligation.


Kenny Kong

Latest:

Focus on Fundamentals for Better Collaboration Across Research Sites and Sponsors

Improving the site-sponsor relationship can get trials off on the right foot and on a path for success.


Rhonda Henry

Latest:

The Two Guiding Principles of Optimal Trial Delivery

Trust-based relationships form the foundation for successful trial management.


Dan Hydes

Latest:

Innovations in Data Capture Transforming Trial Delivery

Advances in technology open door for improved EHR to EDC transfer process.


Annick de Bruin

Latest:

Awareness of Clinical Research Increases Among Underrepresented Groups

Latest CISCRP study provides insight on proactive outreach.


Caroline Smith

Latest:

Rebadging Gains Momentum Amidst COVID

Capacity management and stability offer value for clients, their employees and FSP vendors.


Emily Hardy

Latest:

The Future of Clinical Trials: Turning Data Chaos into Trial Intelligence

Poll taken by leading biotech executives in clinical development addresses state of data quality and management.


Swathi Ramesh

Latest:

Introducing PALADIN

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


Melanie Anderson

Latest:

Opportunities for Improving Clinical Decisions with Patient Centric Remote Blood Sampling Approaches

This article sets out a vision of adopting convenient alternative blood sampling approaches that places the needs of the patient at the center and enables active monitoring, before the onset of clinical events, leading to improved healthcare.


Cytel

Latest:

Empowered Trial Selection with Weighting and Prioritization Tools

Thursday, September 30, 2021 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST Give yourself a competitive edge by learning how the world’s leading designer of innovative clinical trials can help you integrate elements of economic theory to your clinical trial design. Optimize sample size, speed, and power by exploring a broader array of designs and quickly identifying those that meet your objectives.


Helen Yeardley

Latest:

The CRA of the Future: From ‘Road Warrior’ to Site ‘Owner’

Adjusting to the changing dynamics of the clinical research associate role.


Hanna Wide

Latest:

The Rise of Gene Therapy: Advanced Regulatory, Site, and Enrollment Considerations

Developing new pathways to overcome study-related challenges is key to realizing the promise of the latest gene therapies.


Jamie Harper, MHA, CCRP

Latest:

Diversity in Clinical Trials: Strategies and Challenges

Why weighing all of the ‘DE&I’ components is critical at site and sponsor levels.


Aubrey Llanes

Latest:

Thoughtful Design in eCOA Development: Part 2

To derive the greatest benefits from eCOA technology, several elements must work together to create a strong foundation for sponsor success.


Radha Krishnan

Latest:

Managing Biospecimens in Cell and Gene Therapy Trials

Pursuing new tools and capabilities in sample logistics, storage, and data analysis.


Zachary Smith

Latest:

Outsourcing Model Usage and its Relationship to Clinical Trial Performance

Pilot study seeks to validate new and more granular outsourcing model classifications in differentiating performance across custom contract-service approaches.


Jill Sommerville

Latest:

Unleashing Their Potential: The Evolving Landscape of DHTs

Key considerations in deploying fit-for-purpose digital health technologies in drug development.


Mary New

Latest:

Harnessing Patient-Centered Science to Improve Health Outcomes and Commercial Pharma Success

Good scientific principles and practices are essential for maintaining quality data that patients can benefit from.


Bill Meisle

Latest:

Build Relationships with HCPs to Reach Potential Clinical Trial Patients

Increased outreach is necessary to combat poor recruitment and large focus on patients near study centers.


Samantha S. Williams-Gray

Latest:

Clinical Trials and Trust

Understanding the role of social determinants on clinical trial participation and trust.


Preet Singh

Latest:

Future of Clinical Trial Documentation Management: eTMF Integrated with Blockchain

eTMF-blockchain technology offers a myriad of application benefits to data quality and integrity while ensuring compliance to ethical standards.


Guy Rachmuth, PhD

Latest:

Integration of Point-of-Care Devices in Clinical Trials

A look at the future of clinical trial laboratory testing amid the emerging use of new devices at the point of care.


Jasmina Jankicevic, MD

Latest:

Navigating the New World of Dermatology Trials

How partnering with a CRO that has experience in both dermatology and innovative trial approaches can help sponsors differentiate their studies and facilitate recruitment.


Jiangyuan Luo

Latest:

Towards Data-Driven Clinical Trial Planning and Strategy

Optimizing feasibility through increased data collection.

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