Karen Brooks holds the title of senior director of clinical operations at Adare Pharmaceuticals, but the title may be misleading. With Adare being a growing specialty pharmaceutical company, Brooks is currently the entire clinical operations department. That means she wears many different hats, including operations, monitoring, management, recruitment, and retention. At the inaugural Clinical Leader Forum in Philadelphia, Brooks discussed her role in overseeing CROs.
When the Clinical Leader team attended the 2017 DIA Annual Meeting in June, the topic we heard discussed more than any other was real-world evidence (RWE) — that is, information about a drug that is collected outside of clinical trials. RWE is not a new concept, but there are good reasons for all the current attention being paid to it in the pharma industry. For one, the 21st Century Cures Act, enacted into law in December 2016, seeks to speed the FDA drug and medical device approval processes by shifting some of the evidentiary requirements, in certain instances, from clinical trials to post-market — in other words, to “the real world.”
Practical discussions around inclusion often go something like this: A sponsor is interested in anticipating potential barriers to enrollment based on a newly drafted protocol.
When the Clinical Leader team attended the 2017 DIA Annual Meeting in June, the topic we heard discussed more than any other was real-world evidence (RWE) — that is, information about a drug that is collected outside of clinical trials. RWE is not a new concept, but there are good reasons for all the current attention being paid to it in the pharma industry. For one, the 21st Century Cures Act, enacted into law in December 2016, seeks to speed the FDA drug and medical device approval processes by shifting some of the evidentiary requirements, in certain instances, from clinical trials to post-market — in other words, to “the real world.”
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.
Globalization of clinical trials, tightening regulatory requirements, a more competitive and collaborative commercial environment, and an increasingly mobile workforce requires life-sciences companies to standardize and improve regulated content management processes to ensure information is shared with the right people at the right time.
Learn about the challenges for Sponsors and CROs when integrating a vast array of data sources, typical relational database structures and why they don’t work for clinical analytics, as well as the ideal clinical data aggregation solutions for continuous, automatic data consolidation.
The adoption of RBM is increasing as companies provide greater management support, staff training and more sophisticated technology systems. Technology platforms that enable continuous monitoring with near real-time intuitive visualizations, analytic dashboards and applications will allow issues to be identified and addressed early, improving study safety and efficiency.
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The data landscape for clinical operations is complex and comprised of many disparate sources, so a data agnostic solution is essential for full access and visibility into the data. Without an intuitive visual analytics tool, it becomes impossible to navigate data hierarchies and gain meaningful insights into the data.
Insights from medical monitors about the obstacles they face and their impact on the overall study conduct, operational efficiency, and most importantly, subject safety.
The QP process is a necessary process that every sponsor company wishing to undertake trials in, or move product through the European Union must undergo. When faced with this process, many companies are unsure as to what to expect.
When making the switch from paper-based to electronic capture of Clinical Outcome Assessments (COA) data, there are a number of options that study teams must consider in terms of how the data is collected.
See how your colleagues in the drug development industry could surmise our participants’ aggregate answers from a survey of aimed at gaining an understanding of patient mindset and design more effective recruitment strategies.
