Welcome to the Library, where you'll find a selection of industry resources including eBooks, Whitepapers, Webinars, Survey Reports, Research Reports and more.
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This 3-part webinar series is specifically geared toward the non-science professional who needs to better understand industry terminology, science, techniques and issues. This series provides an overview of the science and technology used to enable discovery and the processes scientists use to discover new therapeutics. Download now.
Realizing the potential of Risk Based Monitoring (RBM) requires coordination and collaboration across functions within both the Sponsor and CRO organizations. Dr. David Orloff and Dr. Alex Artyomenko will lead a discussion to explore the cross-functional perspectives and process alignment between Sponsor and CRO. Register Today!
In this webcast we will focus on various encapsulation technologies and manufacturing techniques, and how they may be used to overcome formulation challenges associated with topical products. Register Today!
With clinical trials now so expensive, partly driven by costly drug failures at a late stage, effective and efficient phase IIa trials are becoming more and more important in making early go/no go decisions. Join this live event to hear expert opinions on designing an effective phase IIa proof-of-concept study, what triggers a go/no-go decision at phase IIa and making the most of phase IIa data in dealmaking and collaboration. Register today!
"Make it go faster!" It's not uncommon to hear this phrase from investigators at Life Science organizations generating and analyzing next generation sequencing (NGS) data. In Part 2 of this 3 part series, join our expert panel as they highlight NFS and NAS guidelines and best practices for NGS mapping and alignment pipelines. Register to watch now!
CDER recently issued an updated draft guidance for Analgesic Indications. In this webinar, Brett Gordon and Ben Vaughn provide a high-level review of the agency's guidance, offer strategies for analgesic product development and share experiences with PROs and paper vs. tablet collection. Register Today!
In Part 2 of this series, we will provide a more detailed understanding of the fundamental nature of metabolomics and a visceral understanding of why it has become such a potent ally in bringing clarity to systems biology efforts. Importantly, an explanation will be provided for why metabolomics has only more recently been exploited. Register to watch now!
The use of biomarkers is creating its own set of "big data" challenges. Join Dr. Jonathan Sheldon and Brett Villagrand of Oracle Health Sciences as they examine why trial sponsors are moving away from heavy investments in siloed, home-grown systems. Register Today!
This webinar will outline challenges involved in identifying risk associations with metabolic disease and introduce metabolomics as a new, practical tool to indentify biomarkers for this purpose. Register today to watch now!
Join us as we discuss the benefits to adopting a data driven monitoring solution and give some background to industry changes around site monitoring. Learn what you can do every day to support efficient study delivery, and how PAREXEL is running data driven monitoring. Register to watch now!
This webinar will be an in-depth discussion on "ethnobridging" studies. Join as we discuss how "ethnobridging" studies can speed up drug development, when to incorporate "ethnobridging" studies into the drug development plan, and more. Register to watch today!
Keys to Success for Your Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)
The integrated summary of safety (ISS) and the integrated summary of efficacy (ISE) are critical components of your new drug application (NDA) submission. This webinar will provide insights and important considerations for developing the ISS and ISE sections of your NDA. Register to watch now!
When Efficacy Isn't Enough: Integrating Product Commercialization Strategy into Clinical and Regulatory Planning
Undertaking commercialization strategy and planning from early stages of development can ensure that considerable R&D investment results in successful market and patient access. Join HERON, a PAREXEL Company, in a timely webinar that addresses best practice commercialization planning. Register to watch now!
The FDA has finally issued new guidance outlining requirements for mobile medical device apps. Are companies altering their app development in response to the new requirements, or can they continue as planned, business as usual? This webinar explores the issue. Register to watch now!
Subject matter experts from Remedy Informatics will describe an integrated system and innovative biomedical informatics platform that collects, aggregates, maps and harmonizes biospecimen, laboratory, clinical and study data throughout the bench-to-bedside cycle. Register to watch now
As the FDA demands a more proactive approach to protocol compliance and sites increasingly struggle with patient recruitment and retention, IRT is seeing a shift in the way it is applied in the clinical trial setting. This session will present insights into how sponsors are adding new functionality and applications to IRT to increase site efficiency and patient compliance. Register to watch now!
Clinical trials of targeted cancer drugs focus on those patients most likely to respond, and show the benefits of the drugs much earlier. Join as we discuss these benefits, the design of clinical trials for targeted cancer drugs, and the impact of targeted drugs on clinical trials in the future. Register to watch now!
Demonstrating your compound's proof-of-concept (PoC) is an important developmental milestone. Join us as we discuss ways to maximize your molecule's value, as well as cover the medicalization of early phase clinical development and risk based drug development. Register to watch now!
Beyond Regulations: Developing a Post-Approval Strategy and Plan to Support a Product Throughout its Lifecycle
In this session, we will discuss the market changes driving this demand for evidence, and opportunities for generating and leveraging high-quality late-phase data to optimize product life cycle management. Register to watch now.
Choosing the right country and site for successful patient recruitment is a critical step for entire drug development program. Join us as we address a unique way to leverage informatics insights for optimizing oncology clinical trial site selection based upon consistency of performance and quality indicators across trials. Register to watch now!
Join Thomson Reuters as they discuss how they effectively mine molecular data in biomarker discovery for precision medicine. Find out how network and pathway information can be used for identification of biomarker signatures and discover how MetaBase content integration works with these approaches. Register to watch now!