Authors


Kathy Giusti, MBA

Latest:

Master Protocols in Oncology: A Review of the Landscape

With technology’s increasing ability to gather and analyze previously unmanageable data sets, and medicine’s forays into genomics and targeted therapies, the time of the master protocol may be at hand.


Bradley Smith, PhD

Latest:

Master Protocols in Oncology: A Review of the Landscape

With technology’s increasing ability to gather and analyze previously unmanageable data sets, and medicine’s forays into genomics and targeted therapies, the time of the master protocol may be at hand.


Dixie-Lee W. Esseltine, MD

Latest:

Master Protocols in Oncology: A Review of the Landscape

With technology’s increasing ability to gather and analyze previously unmanageable data sets, and medicine’s forays into genomics and targeted therapies, the time of the master protocol may be at hand.


Lori Goldberg

Latest:

Finding Patient X: The Role of Digital Media in Rare Disease Research

Digital media is becoming a crucial vehicle for finding “Patient X” for rare disease drug trials. Three areas in particular where digital media is helping with the detective work are explored.


Jared Kohler, PhD

Latest:

Preparing Specialty Lab Data for FDA Submission in the New Regulatory Environment

Biomarker and specialty lab data are increasingly being incorporated in FDA submissions given the robust insights they provide on key clinical objectives, including pharmacological effects, and drug safety and effectiveness.


Angela Quigley

Latest:

Preparing Specialty Lab Data for FDA Submission in the New Regulatory Environment

Biomarker and specialty lab data are increasingly being incorporated in FDA submissions given the robust insights they provide on key clinical objectives, including pharmacological effects, and drug safety and effectiveness.


Tobias Guennel, PhD

Latest:

Generative AI Holds the Key to Transforming Trial Design

While still in its infancy, generative AI will continue to be integrated into clinical operations.


John Ebeid

Latest:

This Clinical Trials Day, Honor Employees by Combatting Turnover

John Ebeid, Senior VP of Randstad Life Sciences writes that though International Clinical Trials Day is a time to celebrate the medical researchers who work to make new discoveries for the good of public health - retaining these employees remains a challenge for the entire industry, especially for today's CROs.


Boris Kaganov, PhD

Latest:

BlockChain in Clinical Trials—the Ultimate Data Notary

Assessing the benefits of using blockchain technology as a notary service in the network sharing of clinical data.


Cindy Stevenson, RN

Latest:

The Use of a Single Center, Multi-Location Research Structure For Participation in Large Clinical Trials: The Cleveland Clinic Model

As funding for clinical research trials decreases and sponsors of clinical studies are under increasingly stringent timelines to obtain FDA approval and get new therapies to market, the need increases for well-managed, efficient, and effective clinical trial sites.


Angela Roberts

Latest:

Buy a Diploma, Buy a Degree, Go to Jail

Education Falsification has more consequences than not having a degree.


Pooja Phogat

Latest:

EMA’s Demands for Plain-Language Summaries for Clinical Trial Results that can be Understood by Anyone Could Create new Challenges for Sponsors

From 2019, to comply with requirements for greater transparency around clinical research as part of the EU Clinical Trials Regulation 536/2014, life sciences firms will be expected to prepare plain-language summaries for all Phase I through IV interventional trials, which can be understood by patients, the general public, and experts.


Sandra SAM Sather

Latest:

Key Considerations for the Adoption of eConsent for Sites

There are many benefits for sites adopting electronic informed consent and it is vital that site study teams are not bystanders in the move towards its use.




Luke S. Gill

Latest:

Maximizing Immuno-Oncology Clinical Trial Success

Examining the unique standards and related challenges when assessing the safety and efficacy of cancer immunotherapy candidates.


Greg Gogates

Latest:

The Transformation of Clinical Trials from Writing on Papyrus to the World of Technology

New requirements must be put in place to ensure data quality and integrity.



Anais Silva

Latest:

Selecting Study-Appropriate Clinical Sites in 3 Steps

These three steps should take place in order to ensure an optimal site selection.


Carlos M. Naranjo, MD

Latest:

Special Populations Underrepresented in Oncology Research: Challenges and Solutions to Engage the Hispanic Population

Despite the evidence that the Hispanic population is increasing at a formidable rate, they not only face disadvantages in health care access, but are significantly underrepresented as participants in biomedical research.


Jeffrey S. Handen, Ph.D

Latest:

Agile in Life Sciences R&D

Agile Product Development Methodology holds great promise for use in Adaptive Clinical Study Development.


Christina Corera

Latest:

Agile in Life Sciences R&D

Agile Product Development Methodology holds great promise for use in Adaptive Clinical Study Development.


Dave Espenshade

Latest:

Contract Research Organizations: Leveraging Technology for Success

The handling of payments is frequently an aspect of contract research organizations work that goes underappreciated and undervalued, despite its critical importance.


Thomas Kalfas

Latest:

Common Technical Document Development

Partnership formation is the new trend in common technical document development.


Rajeev Dadia

Latest:

Privacy and Provenance

Provenance is at the heart of the discussion when it comes to the equation of privacy and provenance.


Frenova Renal Research®

Latest:

The Changing Landscape of Clinical Research Sites With Frenova Renal Research

Kurt Mussina, MBA, president of Frenova Renal Research, explains how the site landscape is changing for clinical research. He has years of experience leading a global network of investigators, patients and data scientists involved in clinical studies. He brings a unique perspective to what the major problems in clinical research sites are, including private equity and industry consolidation. Refreshingly, he provides solutions Frenova is implementing that will promote better clinical research sites.



Annalisa Jenkins, MBBS, FRCP

Latest:

Clinical Trials Don't Have to Cost Too Much or Take Too Long

Analyzing data to reveal site performance patterns for better trial planning and execution.


Gen Li

Latest:

Clinical Trials Don't Have to Cost Too Much or Take Too Long

Analyzing data to reveal site performance patterns for better trial planning and execution.


Stephen Arlington, PhD

Latest:

Clinical Trials Don't Have to Cost Too Much or Take Too Long

Analyzing data to reveal site performance patterns for better trial planning and execution.

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