Authors


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.


Tamotsu Yoshiyama

Latest:

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

Planning for ethnic sensitivity from a scientific and regulatory perspective.


Shintaro Hiro

Latest:

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

Planning for ethnic sensitivity from a scientific and regulatory perspective.


Barbara Gladson

Latest:

Type 2 Diabetes Community-Based Recruitment Strategies

Community-based recruitment engages multiple stakeholders in a collaborative approach.


Michael Kuss

Latest:

Patient-Reported Outcomes in Analgesia Clinical Trials for Chronic Pain

PRO measures enrich the evaluation of treatment effectiveness and help sponsors differentiate products.


Christine E. Buben

Latest:

Integrating Patient Retention Strategies

Addressing patient dropout with an arsenal of tools that leverages both technology and communication.


Saliha Akhtar

Latest:

Type 2 Diabetes Community-Based Recruitment Strategies

Community-based recruitment engages multiple stakeholders in a collaborative approach.


Graham Wylie

Latest:

Breaking Down Clinical Barriers

The statistics show that fewer and fewer physicians are willing to take part in trials and that around half of those that do so once never do so again.


William Dalton

Latest:

Biomarker-Driven Oncology Trials

Accelerating the discovery and delivery of personalized medicine.


Frank Makosiej

Latest:

Biomarker-Driven Oncology Trials

Accelerating the discovery and delivery of personalized medicine.


David G. Passov

Latest:

Optimizing Efficiency

Oncology clinical trials: A case for Russia and Eastern Europe.


Eija Metsälä, PhD

Latest:

Investigators’ Experiences in Cooperation with CROs in Clinical Trials in Finland

While several studies and surveys have examined the relationship between sponsors and CROs, there has been little analysis of CRO-investigative site relationships. This study uncovers useful learnings on the positive and negative experiences of investigators in their direct dealings with CROs.

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