The Library

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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WEBINARS

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Improve the Inclusion & Exclusion Criteria for Your Next Clinical Trial

Webinar | Tuesday, September 9th, 2pm ET/ 11am PT | Presented by: Rho

In this webinar, Dr. Jack Modell will provide suggestions and advice on formulating inclusion and exclusion criteria to enhance the quality of subject selection, minimize protocol violations, and avoid protocol amendments. Register Today!

Phase IIa Proof-Of-Concept

Webinar | Now Available On Demand | Sponsored by: PAREXEL

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 to watch now!

Encapsulation Technologies for Topical Drug Products

Webinar | Now Available On-Demand | Presented by: CPL

In this FastCast 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 to Watch Now!

Sponsors, CROs and RBM: Getting Aligned for Success

Webinar | Now Available On Demand | Presented by: Medpace

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 to watch now!

Strategies for Analgesic Development and the New FDA Guidance for Analgesic Indications

Webinar | Thursday, April 10th, 1pm ET/ 10am PT | Presented by: Rho

CDER recently issued an updated draft guidance for Analgesic Indications.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!

Mobile medical apps

Webinar | Now available on-demand | Sponsored by: Kony

Valuable process or another regulatory burden? In this webinar, we'll explore how the FDA's new guidance for mobile medical apps is working, and whether regulators are following through with the expectations they have set. Register to watch now!

Re-inventing HPC To Foster Pharmaceutical Research Innovation

Webinar | Now available on-demand | Sponsored by: EMC Isilon and RCH Solutions

Join us in a discussion about a holistic approach to re-invent and deploy state-of-the-art high performance computing in pharmaceutical R&D. We'll highlight a successful re-invention of HPC at Sanofi and explore practical considerations related to cost, diverse HPC workloads and more. Register to watch now!

Clinical Biomarkers: Big Data Challenges and Best Practices

Webinar | PRESENTED BY: Oracle | NOW AVAILABLE ON-DEMAND

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!

Early phase CNS studies

Webinar | Now Available On Demand | Sponsored by: PAREXEL

Join FierceBiotech as we discuss the use of CNS biomarkers in early clinical trials, CNS imaging technologies in early phase studies and clinical trial design and monitoring. Register to watch now!

Data-driven approach to risk based monitoring

Webinar | Published: Tuesday, March 11th | Presented by: PAREXEL

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!

Begin with the End in mind: Fast-track drug development in Asia

Webinar | Now Available On-Demand | Presented by: PAREXEL

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!

2013 Deal of the Year

Webinar | Now Available On Demand | Presented by: Thomson Reuters

Thomson Reuters Recap analysts have examined hundreds of biopharma deals negotiated in 2013. Join our lively discussion of the five most innovative M&A and Licensing deals from 2013, selected as nominees for the Breakthrough Alliance Award 2013. Register to watch now!

Keys to Success for Your Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)

Webinar | Now Available On-Demand | Sponsored by: Rho

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!