Early Phase Clinical Trial Development
Insights from ExL’s 5th Clinical Trials Phase I & Phase IIA Summit on early phase trials.
Administration Acts Fast to Smooth Transition to New FDA Commissioner
Norman (Ned) Sharpless, director of the National Cancer Institute at the National Institutes of Health, will become FDA acting commissioner.
FDA Only Winner as New Budget Battle Begins
The FDA planned budget features added funds allotted to improved oversight of drugs, biologics, and medical devices.
Transitioning from a Risk-Based Monitoring Approach to Risk-Based Quality Management
What started as an initiative called Risk-Based Monitoring several years ago is now evolving into Risk-Based Quality Management of clinical trials with a much wider impact to the pharma industry.
Envigo launches PATHWAY, a Safety Assessment Solution
Envigo launches PATHWAY
European Medical Device Company Signs Multiyear Agreement to Use OmniComm’s TrialMaster for Ophthalmological Research
European Medical Device Company Signs Agreement to Use OmniComm’s TrialMaster
Worldwide Clinical Trials and Deep Lens Enter Strategic Alliance
Worldwide Clinical Trials and Deep Lens Enter Alliance for Oncology
Almac Group Announces Almac ONE for Supply Chain
Almac Group Announces Almac ONE™ – A Unified Clinical Trial Supply Solution
The University of Debrecen Brings Hungarian Patients in to Clinerion’s Patient Network Explorer
Advarra Acquires Quorum Review IRB and Kinetiq
Advarra Acquires Quorum Review IRB and Kinetiq Research and Technology Consulting
Clinerion’s Patient Network Adds University of Debrecen, Hungary
FDA Will Miss Gottlieb’s Leadership
Gottlieb’s tenure included record new drug approvals and steps taken to curb opioid abuse.
KKS Düsseldorf Signs Multiyear Deal for OmniComm’s TrialMaster EDC Technology
KKS Düsseldorf Signs Deal for OmniComm’s TrialMaster EDC Technology
Cutting Big Data Down to Size in Europe
Recent initiatives demonstrate that European health authorities are serious about combatting the proliferation of threats and opportunities from big data.
The Patient Perspective on Clinical Trials
Survey uncovers deeper learnings of patient perceptions of clinical research and the motivations to participate.
FDA Clarifies Research Policies on Cell and Gene Therapies
FDA officials provide more specific plans for streamlining and modernizing plans for assessing and regulating products for cutting-edge cellular and gene-based medical treatments.
Applied Clinical Trials, March 2019 Issue (PDF)
Click the title above to open the Applied Clinical Trials March 2019 issue in an interactive PDF format.
The Rise of Shared Digital Health Economy and Promise of Accelerated Clinical Research
Patient advocacy organizations are swaying away from a traditional model of granting academic researchers to now supporting biotechnology and pharma companies.
The Road to True Patient Centricity
Patient advocacy groups, patient centricity initiatives, and patient education are the key to putting patients at the center of clinical research.
Me, We, And RWE: The Importance of Designing for the Patient First
In this Q&A, Helen Matthews, Jessica Morris, and Bruce Hellman offer their perspectives on the priorities, opportunities, and challenges of patient centricity in real-world evidence collection.
Portfolio Approach to Optimize Site Selection
Optimization model evaluates the benefits of selecting a portfolio of investigative sites based on advanced analytical models.
The Evolution of Patient Centricity
Examining the distinct actions and advocacy that have advanced the concept from buzzword status to practical implementation in clinical studies.
Getting Serious About Plain Language Transparency
It’s time to establish standard practices to return clinical trial results summaries to patients.
Europe is Getting Its Act Together on Rare Disease Research
Europe is gradually attempting to maximize the potential of the scattered data that, if brought together, might help improve diagnosis and treatment of Europe's 30 million rare disease patients.
