Peer-Reviewed Articles
Technology’s Role in Clinical Trials
How the use of eSource, eTMF, and other cloud-based solutions are changing clinical trials.
Acquiring Medical Guidance in Clinical Trials: Monitoring Team Perspective
By Mohamed El Malt, Vijayanand Rajendran
A critical part of clinical trial conduct is providing medical guidance by the responsible medical monitor to investigative sites and various operations team members, including, but not limited to, clinical research associates and clinical study managers.
Increased Data Transparency Unveils Terminology in Disarray
By René Allard, Frank Biedermann, Elke Ufer, Michael Schmitz, Kai Spielmann
Subject disposition, which is the flow of patients through a clinical trial, requires further discussion for harmonization of terms.
Satisfaction of Healthy Subjects Participating in Phase I Clinical Trials
By John Sramek, Kurt Hauptmann, Hong Ding, Keith Fern, Neal R. Cutler, MD, Sherilyn Adcock, PhD
Assessing the satisfaction of healthy volunteers is important because of the vital role they play in the drug development process via assessment of safety of dose administration and pharmacokinetic characterization of the absorption, metabolism, and distribution of compounds in the body.
Blogs
ERT's Acquisition of PHT
ERT’s announcement of its intention to acquire PHT makes more than sense. And when speaking with the companies’ CEOs, Jim Corrigan and Philip Lee respectively, the potential for success is greater than any challenges the current clinical trials market could throw their way.
Changing the Context of European Pharma
It seems only yesterday that the future for European pharma was personalized medicine. The European Union first gave the term official status in a formal paper in 2008, entitled a Renewed Vision for the Pharmaceutical Sector, in which the Commission included a section on ‘Towards more personalized medicines’.
An Alternative to Risk-Based Monitoring May Prove to be Beneficial
That's because the discussion shifted away from one focused on changing monitoring methods and doing reduced source document verification (SDV) to 'intelligent monitoring.'
Data Analysis
PwC Data Analysis Highlights Our New Health Economy
PwC Health recently did some studies on the New Health Economy that encompasses our society today.
Five-Year Disease Prevalence Only One Driver of R&D Investment
The five-year figure doesn't always determine which cancer types are most commonly being studied in late-phase trials.
Time for Another CRF Migration
Medidata took a look at how eCRF design complexity correlates with the number of migrations performed while a study is actively collecting subject data.
News
Noteworthy
Drug Approved In Pivotal Studies Using DSG’s eSource Data
By Applied Clinical Trials Editorial Staff
Many years before the FDA offered its eSource Guidance in September 2013, Sirion Therapeutics launched its first two pivotal Phase III studies using entirely electronic source data collection.
Role of India in Global Clinical Trial Feasibility
By Chirag Shah
The current regulatory environment of a particular country plays an important role in the geographic selection. For India, it is very relevant because of problems in clinical trials approval and conduct issues during last few years.
2020 Vision: Fulfilling the Future of Clinical Research
By John Potthoff, Mark Penniston, Marc Hoffman, D. Lee Spurgin Jr
Recent advances in proteomics, genomics and metabolomics have enabled us to understand the molecular basis of disease at both the diagnostic and treatment levels.
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Clinical Enterprise Architecture and Data Governance
February 26, 2014 - February 26, 2016
TBD, Philadelphia, PA, USA
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