Authors


Cathy White

Latest:

Engaging Physicians, Staff and Patients for Oncology Trials

Accruing patients depends greatly on engaged, enthusiastic PIs, as they are the gatekeepers in helping patients decide to participate in clinical trials. Building staff awareness and enthusiasm are also essential for retaining participants.


Tina Siemens

Latest:

How Will Technology Drive Global Clinical Trial Change by 2025?

Exploring three pivotal technology areas that could reshape global studies over the next 10 years.


Leslie A. Holland-Klemme

Latest:

Investigator Characteristics & Patient Recruitment in ALLHAT

Analysis of the largest antihypertensive trial ever offers useful blueprint for sites in boosting subject enrollment.


Robert A. Pospisil

Latest:

Investigator Characteristics & Patient Recruitment in ALLHAT

Analysis of the largest antihypertensive trial ever offers useful blueprint for sites in boosting subject enrollment.


Debra Egan

Latest:

Exploring the Role of the Regional Coordinator

How one large academic trial adopted a coordinating center model-helping drive early-model RBM gains


Gail T. Louis

Latest:

Investigator Characteristics & Patient Recruitment in ALLHAT

Analysis of the largest antihypertensive trial ever offers useful blueprint for sites in boosting subject enrollment.


Linda B. Piller, MD

Latest:

Exploring the Role of the Regional Coordinator

How one large academic trial adopted a coordinating center model-helping drive early-model RBM gains


Charles E. Ford, PhD

Latest:

Investigator Characteristics & Patient Recruitment in ALLHAT

Analysis of the largest antihypertensive trial ever offers useful blueprint for sites in boosting subject enrollment.


Therese S. Geraci

Latest:

Exploring the Role of the Regional Coordinator

How one large academic trial adopted a coordinating center model-helping drive early-model RBM gains


Megan Souder

Latest:

Investigator Characteristics & Patient Recruitment in ALLHAT

Analysis of the largest antihypertensive trial ever offers useful blueprint for sites in boosting subject enrollment.



Mark W. Sawicki

Latest:

How Cold Chain Logistics Work in Clinical Trials

Without question, advanced cellular and gene therapies require well-defined cold-chain management solutions that reduce risk and include all elements of packaging, data collection and logistics expertise to ensure high-quality, effective treatments reach the point of care, and ultimately, the patient.


Nami Maruyama

Latest:

Evaluation of Data for Multi-Regional Trials: A Three-Layer Approach

Planning for ethnic sensitivity from a scientific and regulatory perspective.


Bruce Palsulich

Latest:

Safety 360 – A Holistic Approach to Pharmacovigilance

The industry is experiencing a paradigm shift from pharmacovigilance rooted in case processing and compliance reporting to a safety program built around benefit-risk management.


Karen Ivester

Latest:

Overcoming Early Phase Oncology Challenges

How to meet the rigorous safety and efficacy demands critical to evaluating newer targeted cancer therapies.


Eva-Beate Ansmann, MD

Latest:

Critical Appraisal of Clinical Quality Assurance Based on Benchmarking Results: Past - Present - Future

A follow-up survey on clinical quality assurance (CQA) assesses current industry best practices compared to a decade ago, and provides recommendations on this key component of quality management for the future.


Dorette Schrag-Floss, DVM, PhD

Latest:

Critical Appraisal of Clinical Quality Assurance Based on Benchmarking Results: Past - Present - Future

A follow-up survey on clinical quality assurance (CQA) assesses current industry best practices compared to a decade ago, and provides recommendations on this key component of quality management for the future.


Evelyn Jäger, PhD

Latest:

Critical Appraisal of Clinical Quality Assurance Based on Benchmarking Results: Past - Present - Future

A follow-up survey on clinical quality assurance (CQA) assesses current industry best practices compared to a decade ago, and provides recommendations on this key component of quality management for the future.


Karen Briegs

Latest:

An IRB’s Perspective on ePRO

The information in this article serves as a good start by providing factors to keep in mind if your organization is considering adopting ePRO. Appropriateness of ePRO often varies by study and is evaluated individually. As the research landscape continues to shift, being prepared will help ensure a successful IRB review of your study and facilitate a smoother research process overall.


Nathan M. Lee

Latest:

An IRB’s Perspective on ePRO

The information in this article serves as a good start by providing factors to keep in mind if your organization is considering adopting ePRO. Appropriateness of ePRO often varies by study and is evaluated individually. As the research landscape continues to shift, being prepared will help ensure a successful IRB review of your study and facilitate a smoother research process overall.


Leon Wyszkowski

Latest:

6 Ways to Protect the Blind in Clinical Trials

An overview of clinical supply blinding methods in the context of the current research environment.


Susan Diehl

Latest:

6 Ways to Protect the Blind in Clinical Trials

An overview of clinical supply blinding methods in the context of the current research environment.


Steven Yoder

Latest:

6 Ways to Protect the Blind in Clinical Trials

An overview of clinical supply blinding methods in the context of the current research environment.


Shigeyuki Toyoizumi

Latest:

Evaluation of Data for Multi-Regional Trials: A Three-Layer Approach

Planning for ethnic sensitivity from a scientific and regulatory perspective.


Osamu Komiyama

Latest:

Evaluation of Data for Multi-Regional Trials: A Three-Layer Approach

Planning for ethnic sensitivity from a scientific and regulatory perspective.


Satoshi Hashigaki

Latest:

Evaluation of Data for Multi-Regional Trials: A Three-Layer Approach

Planning for ethnic sensitivity from a scientific and regulatory perspective.


Naoki Isogawa

Latest:

Evaluation of Data for Multi-Regional Trials: A Three-Layer Approach

Planning for ethnic sensitivity from a scientific and regulatory perspective.


Steve Hoffman

Latest:

Right Time, Right Channel

Industry news focusing on the people and organizations who work in the clinical trials profession.


Carolann Schimanski

Latest:

Streamline and Improve Study Start-Up

Work is needed if true efficiencies are to be gained in clinical trial performance.


Nobushige Matsuoka

Latest:

Evaluation of Data for Multi-Regional Trials: A Three-Layer Approach

Planning for ethnic sensitivity from a scientific and regulatory perspective.

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