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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The Basics of Biotech 101, 201 & 301

Webinar | Price: $299

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.

Physician Prescribing Trends & Opportunities for Health System-Pharma Collaboration

Webinar | Wednesday, March 16 | 11am ET / 8am PT | Presented By: athenahealth

athenahealth conducted a study to learn how health systems and new reimbursement models are impacting prescribing behavior. We'll discuss our findings, including opportunities for pharma marketers, with a health system leader during this webinar. Reserve Your Spot Today!

Life Sciences and Mobile Apps

Webinar | March 17 | 1pm ET / 10am PT | Sponsored By: Appian

This webinar will examine app strategies in the life sciences industry and how they're changing in the wake of new regulatory requirements. Register Now!

Clinical Research Statistics for Non-statisticians

Webinar | March 17 | 1pm ET / 11am PT | Presented by Rho

Through real-world examples, webinar participants learn strategies for choosing appropriate outcome measures, methods for analysis and randomization, and sample sizes as well as tips for collecting the right data to answer your scientific questions. Register Now!

UDI Crunch Time: Preparing Your Data for Submission to FDA

Webinar | Tuesday, March 22 | 11am ET / 8am PT | Presented By: Reed Tech

The FDA's Sept. 24 UDI compliance date for Class II device labelers is fast approaching. Join this webinar to learn how to locate, gather, check and submit your data to the FDA before the deadline. Reserve Your Spot Today!

Novel Technologies to Deliver Oral Oncology Therapies

Webinar | March 29 | 11am ET / 8am PT / 4pm GMT | Presented by: Catalent

In this webinar, you'll learn about innovative technologies for oral delivery of oncology therapies, enhancing both therapeutic performance and the patient experience. Presented by Dr. Mark Ratain (University of Chicago Medicine), Mr. Julien Meissonnier and Dr. Jeff Browne (Catalent Pharma Solutions). Register now!

End-to-End Evidence Management Can Enable Value-Based, Personalized Healthcare.

Webinar | March 31 | 2pm ET / 11am PT | Presented by Deloitte

Value-based, personalized healthcare is evolving the product conversation for Life science organizations to focus on evidence to deliver a more compelling value proposition to customers. Hear from Deloitte leaders around the importance of an end-to-end evidence management process. Register Now!

Minimizing Risk to Maximize Coverage for the Global Supply of Vaccines

Webinar | April 4 | 10am ET / 7am PT / 3pm GMT | Presented by: Catalent

Join us for this informative webinar: Minimizing Risk to Maximize Coverage for the Global Supply of Vaccines, featuring Bill Hartzel, Director of Strategic Execution, Advanced Delivery Technologies, Catalent Pharma Solutions. Register now!

Quantitative Systems Pharmacology Modeling (QSPM) Case Study in Immuno-oncology

Webinar | April 12 | 11am ET / 8am PT | Presented by: Applied BioMath

Quantitative systems pharmacology modeling (QSPM) approaches help answer complex, critical Go/No-go decisions in drug R&D. Learn how to leverage QSPM to shorten timelines, lower cost, and increase the likelihood of developing best-in-class drugs. Register Now!

Inspection Readiness Considerations with AbbVie

Webinar | April 13 | 2pm ET / 11am PT | Presented by: Veeva

Moving from paper-based to electronic processes not only requires a shift in technology but also a change in mindset. Hear AbbVie’s lessons learned from a mock inspection and other considerations for maintaining an inspection ready TMF. Register now!

UDI So Far: Lessons for Class II Labelers

Webinar | Presented By: Reed Tech | Thursday, April 21 | 11am ET / 8am PT

Class II medical device labelers are working feverishly to meet the FDA's September 24, 2016 UDI compliance date. What should they know about the efforts of other device labelers so far? Reserve Your Spot Today!

UDI After Submission: Managing the Lifecycle of a UDI Record

Webinar | Presented By: Reed Tech | Tuesday, May 17 | 11am ET / 8am PT

Medical device labelers have been working hard to comply with the FDA's Final Rule for Unique Device Identification (UDI). But what happens to a UDI record after submission? Reserve Your Spot Today!

Special Considerations for Managing Immuno-oncology Studies - A New Paradigm

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

Immuno-Oncology Webinar: We are in a new era for researching cancer treatments. Join Medpace medical and operations experts as they discuss the unique considerations for managing immuno-oncology studies as well as insights into best practices. Register now!

Fastest Route to Clinic and Market Enabled by Optimizing API Properties and Formulation

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

The clinical and commercial success of a new chemical entity (NCE) requires pre-formulation studies of drug candidates and development of suitable formulations based on the physicochemical and biopharmaceutical properties. Through expert content and case study examples, this webinar will highlight the strategies and state-of-art screening, particle size reduction and formulation technologies to optimize the properties and formulation of your drug candidates. Register to watch now!

Rare Disease 20/20: A Look at the Challenges and Opportunities in Rare Disease Clinical R&D

Webinar | Now Available On-Demand | Presented By: BBK Worldwide

Join the National Organization for Rare Disorders (NORD), Xenon Pharmaceuticals and BBK Worldwide as they take a closer look at the challenges and opportunities in rare disease clinical R&D. Registration is free – click here.

Next Generation GxP Systems in the AWS Cloud

Webinar | Now Available On-Demand | Presented by Amazon Web Services

Amazon Web Services (AWS) has developed a compliance resource that provides guidance to organizations who use AWS in their GxP systems. This webinar will illustrate ways the AWS Cloud facilitates GxP compliance and helps improve infrastructure transparency, consistency, and auditability. Register to watch now!

Analytic Methods for Identifying Quality Risks in Clinical Trials

Webinar | Now Available On-Demand | Presented By: Medidata

Join this webinar on analytic methods to help you minimize regulatory review cycles. Learn how automated systems are using advanced statistical algorithms and machine learning techniques to help sponsors shave months off their quality audit processes and avoid deficiencies. Register to Watch Now!

Drug Manufacturing Solutions in a Complex Industry

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

Through expert content and case study examples, this webinar will focus on flexible manufacturing solutions to address the unique needs of today’s pharmaceutical pipelines, with an emphasis on successful technology transfer and tailored manufacturing services. Register to watch now!

Literature Surveillance in Pharmacovigilance; Current Trends, Methods and Challenges

Webinar | Now Available On-Demand | Presented By: Elsevier

Scientific and medical literature is an important source of information to identify suspected adverse reactions with medicines. Join us to learn more about drug safety and literature monitoring for pharmacovigilance. Register to watch now!

Protocol Design: What You Need to Know to Ensure a Successful Study

Webinar | Now Available On-Demand | Presented by Rho

Solid protocol design is critical to clinical development. No matter how well executed a clinical study is, if the underlying design is flawed, it wasn't worth doing. In this webinar, David Shoemaker, SVP R&D, will point out common mistakes and challenges associated with developing a protocol. Register to watch now!

Optimizing Your Clinical Supply Chain Strategy for Asia-Pacific Studies

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

In this webinar we will explore how to leverage the major clinical supply centers of China, Singapore and Japan to support clinical trials within the Asia-Pacific region for both local and global study sponsors. We will explore clinical packaging, logistics and import/export considerations that should be taken into account when developing a clinical supply strategy and why there is no substitute for on-the ground local expertise. Register to watch now!

Quality Documentation Control: How to Move From Paper to Regulated Cloud in 4 Weeks

Webinar | Now Available On-Demand | Presented by Veeva

How do you maintain control over regulated content with a mobile and global team? Learn how Medicines360, a nonprofit company, moved from paper-based to electronic content processes in just 4 weeks with Veeva Vault QualityDocs. Register to watch now!

Improving Commercial Content Compliance & Productivity: Results from New Industry Survey

Webinar | Now Available On-Demand | Presented by Veeva

Discover new trends and strategies to improve compliance and marketing productivity. See how your organization compares. Register to watch now!

Capturing the Voice of the Patient - ePRO, Real World Data, and the Future of Clinical Trials

Webinar | Now Available On-Demand | Presented By: Medidata

Regulators are becoming wary of self-assessments captured on paper, so join this session to learn what is currently driving ePRO decisions. Register to Watch Now!