Authors


Frank Biedermann

Latest:

Increased Data Transparency Unveils Terminology in Disarray

Subject disposition, which is the flow of patients through a clinical trial, requires further discussion for harmonization of terms.


René Allard

Latest:

Increased Data Transparency Unveils Terminology in Disarray

Subject disposition, which is the flow of patients through a clinical trial, requires further discussion for harmonization of terms.


Elke Ufer

Latest:

Increased Data Transparency Unveils Terminology in Disarray

Subject disposition, which is the flow of patients through a clinical trial, requires further discussion for harmonization of terms.


Kai Spielmann

Latest:

Increased Data Transparency Unveils Terminology in Disarray

Subject disposition, which is the flow of patients through a clinical trial, requires further discussion for harmonization of terms.


Deborah Covington

Latest:

The Remote Patient-Centered Approach in Clinical Research

In the healthcare arena, the concept of patient-centeredness has expanded over the last 50 years, beginning as a term to describe patient engagement in self-health management and evolving to include various aspects of patient engagement in healthcare research.1


Stephen Nabarro

Latest:

Risking it All? Going All in on RBM Adoption

Cancer Research UK (CRUK) followed such advice when it decided to have its Center for Drug Development (CDD) adopt a risk-based monitoring (RBM) approach across its entire portfolio of clinical trials.


Mark Nixon, PhD

Latest:

Key Strategies in Sustaining the Investigator Pool

The sharp rise in ongoing clinical research studies is driving demand for greater participation in research by physicians as well as by patients.1


Richard G. Pellegrino, MD, PhD

Latest:

Integrated Clinical Research Systems: A Chance to Reinvent

The organization of healthcare is changing rapidly. The healthcare delivery system is increasingly powered by payers and regulators, and this directs both clinical medicine and drug development. Partly because of this change, the drug development process has been heavily scrutinized, and a great emphasis has been placed on more efficient translation of basic science into useful medicines.



D. Lee Spurgin Jr

Latest:

2020 Vision: Fulfilling the Future of Clinical Research

IntroductionAfter decades of promise, we have begun to realize the fruit of “-omics” technology. Recent advances in proteomics, genomics and metabolomics have enabled us to understand the molecular basis of disease at both the diagnostic and treatment levels. Equally important, a growing suite of biomarkers now provides predictive value for diagnosis, disease progression and cure/remission.


Marc Hoffman

Latest:

2020 Vision: Fulfilling the Future of Clinical Research

IntroductionAfter decades of promise, we have begun to realize the fruit of “-omics” technology. Recent advances in proteomics, genomics and metabolomics have enabled us to understand the molecular basis of disease at both the diagnostic and treatment levels. Equally important, a growing suite of biomarkers now provides predictive value for diagnosis, disease progression and cure/remission.


John Potthoff

Latest:

Eliminating ‘Disruption’ for Patients in Clinical Trials

Exploring new ways to smooth the path toward better participation for patients and other research and healthcare stakeholders.


Chirag Shah

Latest:

Regulatory Approval in India: An Updated Review

Issues concerning the drug approval process in India have occurred in clinical studies resulting in a reduced interest from sponsors. The Drug Controller General of India (DCGI) has been working to amend and update it’s policies to stimulate growth in this sector.


Kara Dennis

Latest:

Bring Your Own Device for Trial Outcome Assessment

Survey uncovers the challenges, myths, and potential useful strategies associated with BYOD adoption.


Company Press Release

Latest:

Syneos Health 2022 Health Trends

Insights from Syneos Health’s 2022 Health Trends: Insights for Industry Change Agent.


Heather Davis

Latest:

Planning for Success in Late Phase Global Oncology Trials

Following four key study-design steps is crucial to the delivery of a successful cross-border cancer study


Glenn Keet

Latest:

Sweeping Aside the Hurdles of EMR and EDC Integration

Historically, some longstanding challenges have hindered efforts to integrate patient data from EMRs (Electronic Medical Record systems) with EDC (Electronic Data Capture) systems.


Jessica Holden Kloda

Latest:

FDA’s Expedited Review Process: The Need for Speed

Outlining the requirements and benefits of FDA's four expedited drug approval pathways.


Shahza Somerville

Latest:

FDA’s Expedited Review Process: The Need for Speed

Outlining the requirements and benefits of FDA's four expedited drug approval pathways.


Jim Zhang, Ph.D

Latest:

Global Biomarker and Companion Diagnostics Outsourcing Market

Over recent years global drug companies large or small have recognized that one root cause of the high failure rate in their clinical development lies in the selection of right therapeutic targets.


Barbara A Ricker

Latest:

Evaluating the Effects of Therapy Masking

Using a specific trial, the importance of assessing the success of therapy masking is examined.


Alexander R Arslan

Latest:

Evaluating the Effects of Therapy Masking

Using a specific trial, the importance of assessing the success of therapy masking is examined.


Katherine M Seymour

Latest:

Evaluating the Effects of Therapy Masking

Using a specific trial, the importance of assessing the success of therapy masking is examined.


April Slee

Latest:

Evaluating the Effects of Therapy Masking

Using a specific trial, the importance of assessing the success of therapy masking is examined.


Jeffrey L Probstfield, 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


Suzanne Tran

Latest:

Where is the “Quality” in GCP?

Over the years, clinical study management has become more fragmented. There are more organizations participating in a study, each bringing their own experiences, interpretations of requirements including how quality is defined. How is it possible that requirements and quality be interpreted so differently?


Dante Ciambella

Latest:

Sentiment Analysis: Understand Your Healthcare Customers

 Sentiment analysis can give health care organizations a competitive edge in understanding what customers think about their healthcare experience, to help reduce costs and improve care service and to lead to new clinical research and treatments. In addition, it taps into a new channel of pharmacovigilance input information that can enable Marketing Authorization Holders to keep abreast of opinions on the safety of their products in real time.


Laura Conti

Latest:

Sentiment Analysis: Understand Your Healthcare Customers

 Sentiment analysis can give health care organizations a competitive edge in understanding what customers think about their healthcare experience, to help reduce costs and improve care service and to lead to new clinical research and treatments. In addition, it taps into a new channel of pharmacovigilance input information that can enable Marketing Authorization Holders to keep abreast of opinions on the safety of their products in real time.


Massimo Ruffolo

Latest:

Sentiment Analysis: Understand Your Healthcare Customers

 Sentiment analysis can give health care organizations a competitive edge in understanding what customers think about their healthcare experience, to help reduce costs and improve care service and to lead to new clinical research and treatments. In addition, it taps into a new channel of pharmacovigilance input information that can enable Marketing Authorization Holders to keep abreast of opinions on the safety of their products in real time.


Umberto Scilinguo

Latest:

Sentiment Analysis: Understand Your Healthcare Customers

 Sentiment analysis can give health care organizations a competitive edge in understanding what customers think about their healthcare experience, to help reduce costs and improve care service and to lead to new clinical research and treatments. In addition, it taps into a new channel of pharmacovigilance input information that can enable Marketing Authorization Holders to keep abreast of opinions on the safety of their products in real time.

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