The FDAAA Title VIII, which required clinical trial results to be disclosed on ClinicalTrials.gov, went into effect in September 2007. The industry has now reached the 10-year anniversary of the act, which is a good time to reflect on progress that has been made and whether the requirement has actually improved transparency in clinical trials.
Pharmaceutical companies are experiencing a significant change because of the shift in drug development toward more complex and expensive cell therapies with a focus on rare diseases.
According to a common refrain, blockchain will “transform” and “disrupt” the life sciences industry. While the technology’s applications in industries such as banking and broader financial services are readily apparent and, in fact, already being adopted, tangible applications in the life sciences prove more nebulous.
Over the holiday season, I took the time to reflect on the whirlwind and craziness of the past year. I don’t know about you, but I was ready for some comic relief, so I indulged in one of my favorite pastimes -- attending an improv comedy show. It’s been 10 years since the original Whose Line Is It Anyway ended its successful run as a TV show (much to my chagrin), but Saturday Night Live is alive and well after 40 years.
This white paper represents a compilation of industry best practices for designing, implementing and leveraging randomization and trial supply management (RTSM) software in clinical trials.
A discussion of the commonly encountered hurdles in studying rare diseases and how a cohesive and holistic approach can mitigate issues and help bring new treatments to patients.
This requirement to submit promotional material in eCTD will add complexity and more room for error, making it all the more important to prepare for potential challenges.
Before the protocol authoring process even begins, a variety of activities and decisions are necessary to establish a strategy for success. The following steps provide concepts and considerations that are essential in formulating the details that will become the protocol synopsis and ultimately the clinical study protocol.
Welcome to Clinical Leader, the premier online community that helps streamline clinical research by connecting trial sponsors and cutting edge service providers. Clinical Leader is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.
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Takeaways from MAGI 2017 West regarding changes taking place in the industry at large and an analysis of what’s driving those changes.
Explore the impact of the high cost of clinical trials and how the industry can mitigate it.
What to consider when determining if you should use an Electronic Data Capture (EDC) System for your medical device study.
Electronic informed consent, or eConsent, is one technological advancement introduced to clinical trials that is escalating in its adoption. In this blog, get 5 tips for implementing and preparing for eConsent.
With the built-in flexibility and control of some eClinical solutions available today, why wouldn't you want to do it all yourself?