Authors


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.


Jaana Hynynen

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.


Abby Abraham

Latest:

New Survey Measures the Pulse of RBM & ICH-E6 (R2) Adoption in the Clinical Trials Industry

Abby Abraham, Vice President, Data Analytics, and RBM for OmniComm Systems, writes about a new survey that highlights gaps in the conversation surrounding the industry’s adoption and implementation of risk-based approaches to monitoring.


Barry Milton

Latest:

A Guide to Risk-Based Study Startup

For organizations looking to increase transparency in the study startup process, the sheer volume of data and the silos in which they exist can be a daunting hurdle. New generation systems enable teams to capture, analyze, share, and visualize study startup data in one system.


Gail Smith-McCarthy

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.


Pirkko Lepola

Latest:

Pharmaceutical Industry and Pediatric Clinical Trial Networks in Europe – How Do They Communicate?

Pair of surveys provide a rare formal peek into the relationship between sponsors and pediatric clinical research networks. A lack of awareness, incongruent expectations, and insufficient communication have hindered collaboration between the two parties. Developing standardized procedures and better information exchange could help strengthen the connection going forward.


Jennifer Preston

Latest:

Pharmaceutical Industry and Pediatric Clinical Trial Networks in Europe – How Do They Communicate?

Pair of surveys provide a rare formal peek into the relationship between sponsors and pediatric clinical research networks. A lack of awareness, incongruent expectations, and insufficient communication have hindered collaboration between the two parties. Developing standardized procedures and better information exchange could help strengthen the connection going forward.


Pamela Dicks

Latest:

Pharmaceutical Industry and Pediatric Clinical Trial Networks in Europe – How Do They Communicate?

Pair of surveys provide a rare formal peek into the relationship between sponsors and pediatric clinical research networks. A lack of awareness, incongruent expectations, and insufficient communication have hindered collaboration between the two parties. Developing standardized procedures and better information exchange could help strengthen the connection going forward.


Susan Tansey

Latest:

Pharmaceutical Industry and Pediatric Clinical Trial Networks in Europe – How Do They Communicate?

Pair of surveys provide a rare formal peek into the relationship between sponsors and pediatric clinical research networks. A lack of awareness, incongruent expectations, and insufficient communication have hindered collaboration between the two parties. Developing standardized procedures and better information exchange could help strengthen the connection going forward.


Erica Pascal, PhD

Latest:

Clinical Trials, Social Media and Your Patent

Considerations should be made in regard to social media and clinical trials. Public use and disclosure of an invention before filing for a patent can invalidate the claims and locating evidence to demonstrate public use of an invention can be challenging, particularly if the use is not commercial or publicized.


Laura Hilty

Latest:

Top 3 Patient-Centric Payment Trends

When paying and reimbursing clinical research volunteers for study participation, what can be done to make the experience more patient centric?


Jeff Daurity

Latest:

mHealth: Trendy or Revolutionary?

mHealth is making a strong case for its ability to optimize clinical trials and improve engagement with participants and patients.




Validic

Latest:

Digital Health Devices & Data in Trials Today

In this eBook, industry leaders Validic, Quintiles and Duke Clinical Research Institute explore the four categories of digital health technologies--wearable fitness devices, clinical devices, sensors and applications-and discuss what each category includes, endpoints they collect and how they’re being used in trials today.


* Michael Herschel, MD

Latest:

An Ideal SOP System

A "can’t live with them, can’t live without them" attitude is revealed in survey of standard operating procedures in the management and conduct of clinical trials.

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