Regulatory Sciences
Maximizing Clinical Trial Success: Strategic Approaches for Adding EU Member States in CTIS
Strategic Guidance for Expanding Clinical Trials Across EU Member States with CTIS Expanding a clinical trial to additional Member States within the European Union (EU) Clinical Trial Regulation...
Clinical Research Solutions
Pros and Cons of Working with a CRO
A Contract Research Organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract...
Regulatory Sciences
Mastering Clinical Trial Submissions in Europe: A Guide for Drug Developers
Launching a clinical trial in Europe is a complex but rewarding endeavor, requiring careful navigation of regulatory frameworks, ethical requirements, and submission processes. Recent regulatory...
Pharmacovigilance
EU Clinical Trials Regulation: Time Is Running Out, Are You Ready?
On January 31, 2022, the EU Clinical Trials Regulation 536/2014 (CTR) came into force with a transition period of three years. Now, as that transition period comes to a close, the process and need...
Single Arm Trials: How to Make the Future Brighter
Randomized clinical trials (RCTs) are widely recognized as the gold standard for clinical and regulatory decision-making. Indeed, RCTs would be required in most cases, in particular when modest...
Challenges in Oncology Trials: How to Navigate the Evolving Regulatory Landscape
Setting the Scene: What Makes Oncology Clinical Trials Different? Ever increasing knowledge of the molecular basis of malignant disease has stimulated development of targeted agents. This often leads...
Clinical Trials in Australia: Unlocking Value for Clients
In recent years, Australia has emerged as a leading destination for conducting clinical trials, attracting pharmaceutical, biotech, medical device/diagnostic companies, and research organizations...