Conversations about clinical trial data privacy in clinical trials require an in-depth understanding of key regulations — and with multinational trials becoming more prevalent, being familiar with global regulations has become paramount. In the US, HITECH (Health Information Technology for Economic and Clinical Health) and HIPAA (Health Insurance Portability and Accountability Act) are the main…
A clinical data manager is responsible for guaranteeing that statistical results and information from clinical trials are accurately recorded and reported, both during and after the study is complete. This is accomplished by carefully designing data collection tools and methodology for interrogating data. Here, our EDC clinical trial data management expert discusses the role of…
Clinical trials and therapeutic development are at the crux of the modern healthcare system. You can’t expect to have state-of-the-art systems, medical technology, and modern therapies without a robust clinical research software. These are fundamental to maintaining the quality of healthcare that is provided across the globe. These trials are responsible for discovering impactful vaccines,…
With automation and artificial intelligence, clinical trial teams can recruit and retain more patients. Plus, predictive analytics allow clinical trial teams to make better predictions, and therefore, better decisions about patient behavior — this way, they can reach out before a study ends. Currently, AI and predictive analytics can benefit clinical trial monitoring and clinical…
A clinical trial is a study that tests how well new medical techniques work. An important characteristic to any good clinical trial is appropriate screening and randomization practices. Planning is the foundation of a good clinical trial. The steps you take before distributing the first treatment or medication can lay the foundation for positive patient…
Coordinating the needs and roles of various stakeholders is one common challenge that every clinical trial face. Read as we explore the needs of stakeholders in Decentralized Trials. DCTs (decentralized clinical trials) are defined as studies executed via local/mobile healthcare and telemedicine providers, using technologies and processes that differ from the traditional clinical trial model.…
Clinical research and modern medicinal development are undergoing a technological transformation that has accelerated further in the aftermath of the recent pandemic. There is a greater need for clinical research to be robust, more efficient, and quicker because it helps create medical treatments that counter modern diseases, and a forefront of this effort includes electronic…
You may have heard the term “ePRO”, but might not fully understand exactly “what is ePRO in clinical trials”? The recent pandemic has shown us an urgent need to overhaul the entire healthcare system, especially how we conduct clinical research, which is important to modern therapeutic development. Having said that, the clinical research industry has…
Randomized control trials are considered one of the most effective ways of conducting modern medical research and testing therapeutic treatments. They are now considered as the gold standard for pharmaceutical companies looking to develop cutting-edge treatments to counter modern diseases. Clinicians are now actively looking to implement a randomized control trial method along with modern…
Randomization in clinical trials is a core component of any clinical trial that is seeking marketing authorization by the FDA. As you may know, the world of clinical trials is heavily regulated and controlled by relevant government bodies. Clinicians, CROs, sponsors, and others involved in modern medical research must adhere to several rules and regulations…