Peer-Reviewed Articles

Exploring the Role of the Regional Coordinator

By Therese S. Geraci, Lillian Carroll, Connie Kingry, Janice M. Johnson, SMC, Debra Egan, Jeffrey L Probstfield, MD, Sara M. Pressel, Linda B. Piller, MD

The largest antihypertensive trial ever conducted throughout North America, ALLHAT, was organized using a coordinating center model for oversight. Regional coordinators played a key role in carrying this trial out.

Are Phase III Clinical Trials Really Consistently Behind Schedule?

By Harold E. Glass, PhD, Lucas Miller Glass, Jesse M.Glass, Phuong Tran

With a unique business model, pharmaceutical companies and their subcontractors need to find every way possible to shorten drug development times consistent with patient safety. The challenges facing commercially oriented organizations developing prescription drugs are substantial.

How Do iComply? Regulatory Topics Surrounding mHealth in Clinical Trials

By Philip Coran

Outlining several critical areas of regulatory oversight that clinical trial researchers need to consider when using mHealth technologies.

Data Analysis

Late Phase Study Trends and Market Outlook

This recent report explores key factors behind customer satisfaction and other dynamics within the Late Phase market.

Phase II-III Market Dynamics

Report shines light on the current state of the Phase II/III clinical trial market and its anticipated direction into 2020.

A Different Look at Protocol Procedure Complexity

A substantial increase in procedure complexity should be reflected in increasing per patient costs of Phase III clinical trials,which is not true from these data.

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Events

Pharmacovigilance Final Rule Summit on IND Safety Reporting
August 16, 2016 - August 17, 2016 / Alexandria, VA

Central Labs and Sample Logistics Conference
August 24, 2016 - August 25, 2016 / Philadelphia, PA

World Drug Safety Congress Europe
September 14, 2016 - September 15, 2016 / Nice, France

Lay Summaries Summit 2016
September 19, 2016 - September 20, 2016 / Philadelphia, PA

Real World Evidence 2016
September 22, 2016 - September 23, 2016 / Philadelphia, PA


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Blogs

What Can Europe Hope for from Health Technology Assessment?

By Peter O'Donnell

The Health Technology Assessment is seen as a way European pharma can achieve sustainable healthcare while promoting innovation. Despite these potential advances, questions about implementation remain.

Clinical Trial Design & Management: Best Practices for Small Budget Studies

By Eric Morrie

ClinCapture hosts a panel discussion with experts from CROs and sponsor companies to discuss conducting quality clinical trials in a cost effective manner.

FDA to Decide the Future of Diabetic Finger Pricks

By Lisa Henderson

Continuous Glucose Monitoring (CGM) devices have the ability to replace the traditional finger-prick to measure glucose levels in a patient’s blood. Quintiles’ device expert, Sam Osman, explains CGM and how the FDA decision could affect clinical trials.

Noteworthy

Drug Development through Modeling and Simulation - the Business Case

By Harold E. Glass, PhD, E.M. Kolassa, MBA, PhD, Edmundo Muniz, MD, PhD

The drug development process has been seen as inefficient and disappointing by those in the R&D space. Modeling and Simulation provides a potential relief to these issues by delivering significant business, scientific and clinical value to drug developers.

Medical Device Body of Knowledge Training Strategy

By Michael Towse

To provide more targeted training and validate understanding to employees, it is important to establish baseline knowledge. This case study explores how Chiltern developed its Medical Device Body of Knowledge training program.

Latest Business and People News

By Applied Clinical Trials Editors

Updated employee announcements, business news and recognition in the industry today.

E-Books

Oncology Clinical Trials

Oncology remains the therapeutic area with the most drug failures, the lowest numbers of patients enrolled and the highest with the number of drugs in clinical trials. Many trends in oncology clinical trials seek to address these challenges and include the use of biomarkers, immunotherapies, and adaptive designs.

 

Cardiac Safety Assessment Update

This special report offers an article regarding current FDA thinking and future direction with these assessments. ERT--a cloud platform solutions provider that captures quality efficacy and safety endpoints in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, and Clinical Outcome Assessments—offers expert view on this regulatory change.

 

Clinical Trial Management

Clinical trials have increased in number and complexity for numerous reasons—global trials, outsourcing, protocol requirements, and multiple regulatory issues. Factor this with the increased need to bring efficiencies and lower prices to the clinical trial process, and the need to stay on top of trials only becomes more crucial. This eBook will include articles on logistics of clinical trials supplies, negotiating with investigative sites, use of e-signatures and more.

 

 

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