Authors


Grant Dietrich

Latest:

Focus on the Patient: The Digital Evolution of IRT

Cenduit has benefited greatly from the relationship we have with our parent companies, from Quintiles’ clinical development experience to Thermo Fisher Scientific’s clinical supply chain know-how.


Lisa Carlson

Latest:

Death Waivers an Incomplete Picture of Drug Safety

Examining the practical significance of reporting patient deaths due to main disease progression.


Nickolai Usachev, MD

Latest:

Death Waivers an Incomplete Picture of Drug Safety

Examining the practical significance of reporting patient deaths due to main disease progression.


Maxim Belotserkovskiy, MD

Latest:

Interexpert Agreement on Adverse Events’ Evaluation

Study measures the differing judgment levels between clinical investigators and drug safety experts.


Margarita Mare, MD

Latest:

Death Waivers an Incomplete Picture of Drug Safety

Examining the practical significance of reporting patient deaths due to main disease progression.


Jane Baxendale

Latest:

Eyes Play a Focal Role in Research

Two unique techniques help characterize pharmacodynamic drug effects in healthy subjects.


Linda Bowers

Latest:

In Pursuit of Enlightenment

Knowledge is power, but power is of no value if you don't exercise it.



Lindsay McNair, MD

Latest:

Human Gene Transfer Studies: What Clinicians Should Know

This experimental technique is being studied to see whether it could treat certain health problems.


Chris Jenkins, PhD

Latest:

Human Gene Transfer Studies: What Clinicians Should Know

This experimental technique is being studied to see whether it could treat certain health problems.


Jud Gardner

Latest:

How Technology Can Help ClinOps Leaders Build a Quality Culture

Clinical trials are time sensitive, costly endeavors with high-risk and high-expectations at every juncture.


Pem Guerry

Latest:

A Look at Independent E-Signatures to Limit the Paper Burden in Clinical Trials

Across the pharmaceutical industry, advances in digital technology play a key role in driving the efficiency of the drug development process, particularly for clinical trials.


Jonca Bull, MD

Latest:

Barriers to Trial Recruitment and Possible Solutions

Survey takes deep dive into enrollment hurdles, aims to inform future recommendations for improvement.


Gina Uhlenbrauck

Latest:

Models of Engagement: Patients as Partners in Clinical Research

Exploring three distinct patient partnership models to help researchers assess which methods of engagement could work best for their clinical programs.


Elizabeth Mahon

Latest:

Barriers to Trial Recruitment and Possible Solutions

Survey takes deep dive into enrollment hurdles, aims to inform future recommendations for improvement.


Pat Furlong

Latest:

Barriers to Trial Recruitment and Possible Solutions

Survey takes deep dive into enrollment hurdles, aims to inform future recommendations for improvement.


Jamie Roberts

Latest:

Barriers to Trial Recruitment and Possible Solutions

Survey takes deep dive into enrollment hurdles, aims to inform future recommendations for improvement.


Nick Simmons-Stern

Latest:

Designing Alzheimer’s Disease Clinical Trials For Success

Alzheimer’s disease (AD) is and will remain one of the most unyielding public health crises of the 21st century. Aging global populations translate to a constantly growing prevalence of a disease with no cure and an immense cost of care. In the United States alone, recent estimates1 suggest that 28 million people will develop AD by midcentury. Approximately 25% of the annual Medicare budget will be spent treating the disease – a projected $330B in 2040 – with hundreds of billions more in indirect costs.





Sergii Myronenko, MD

Latest:

Site Challenges in Eastern Europe

Survey sheds light on the regional-specific risks of managing clinical trial sites in Eastern Europe.


Nikolay Grechko, MD

Latest:

Site Challenges in Eastern Europe

Survey sheds light on the regional-specific risks of managing clinical trial sites in Eastern Europe.


Kateryna Bezditko, PharmD, PhD

Latest:

Site Challenges in Eastern Europe

Survey sheds light on the regional-specific risks of managing clinical trial sites in Eastern Europe.


Jason Monteleone

Latest:

Is a Bigger CRO Better?

Much of the growth that has taken place in the top tier of CROs in recent years has been in the acquisition of some of the smaller, more innovative companies, rather than an increase in the number of compounds under study.


Adam Beauregard

Latest:

The Basics of Clinical Trial Centralized Monitoring

Examining the practicality of implementing CM techniques to drive trial oversight efficiency while saving on-site monitoring resources and costs.


Tom Koch

Latest:

Clinical Trial Data Stewardship

Amid the push for clinical trials to adopt more modern digital data technologies, the job of assuring adherence to key data quality and integrity principles is achievable under current regulations governing electronic record-keeping. Doing so, however, will require a new and reinvented framework: data stewardship.


Prithul Bom

Latest:

Mobile Medical Apps as Investigational Devices

Considerations for Using a Mobile Medical App as an Investigational Device


Elizabeth Brooks

Latest:

Mobile Medical Apps as Investigational Devices

Considerations for Using a Mobile Medical App as an Investigational Device


Anzalee Khan

Latest:

Assessing Suicidality in Clinical Trials: Paxil's Wakeup Call

The authors concluded that its secondary analysis of existing data from Study 329 demonstrated clinically significant increases in harms, including suicidal ideation and behavior (SIB) and other serious adverse events in individuals taking paroxetine.

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