ObjectiveGI Collaborates with Clinical Research IO
Regenerative Medicine Companies Pursue Unique Regulatory Pathways
Yaky Yanay, CEO of Pluristem, talks with Moe Alsumidaie about his experience and the strategies Pluristem implemented in regenerative medicine clinical trials.
Saama and Tufts Team Up to Assess Technology Adoption
Elligo Health Research Partners with Austin Cancer Center
DSP Clinical Announces New Co-Monitoring Service
Tufts: Growth in Rare Disease R&D Challenging Development Strategy and Execution
Symbio Signs Five-Year Agreement for OmniComm’s TrialMaster
U.S. Research Launches Initiative to Help Treat Dementia
Clinerion Partners with 2 GL Outsourcing
Denmark's Medicines Agency Tightens Up on Conflicts of Interest
New rules in Denmark to eliminate potential conflict-of-interest issues follow the lead of the European Medicines Agency's repeated attempts to rebut allegations of pro-industry bias.
PHARMASEAL Launches Second Release of Engility CTMS
Keeping Up with the Regulatory Expectations
Getting Ready for Godot: Rehearsals for Europe's New Clinical Trials Rules
Peter O'Donnell discusses the European Commission's compendium and how triallists are not only obliged to comply with the current rules, but at the same time to prepare themselves for the future rules.
Applied Clinical Trials, July/August 2019 Issue (PDF)
Click the title above to open the Applied Clinical Trials July/August 2019 issue in an interactive PDF format.
Yaky Yanay, CEO of Pluristem, will discuss his experience and the strategies Pluristem implemented in regenerative medicine clinical trials.
Tackling the Challenges of Transitioning to RBM
Methods sponsors and CROs can use to minimize the growing pains associated with RBM implementation.
Too Fast or Too Slow? Debate Intensifies over FDA Regulatory Requirements
Patient advocates debate whether FDA approval on small, early clinical studies is too fast-tracked for efficacy and safety, or too slow due to long review processes.
Challenges Emerge from Low NASH Awareness
Addressing the current hurdles and potential solutions in nonalcoholic steatohepatitis awareness and clinical trial enrollment.
Zeroing in on Real Patient-Centric Metrics
A look at the opportunities and challenges around patient-centric trials and patient centricity in pharma.
The Growing Threat to Clinical Trials and Research in a Fracturing Europe
The consequences UK faces after being pulled out of the EU without any healthcare and research deal may affect all of Europe.
The Gene Therapy Product Development Process
Navigating the many complexities in clinical trials, manufacturing, and regulatory interaction in moving gene therapies from development to market.
Adopting eISF for Remote Quality Oversight of Trials
Exploring the use of electronic investigator site files for review of regulatory documents and informed consents.
