Continuous Glucose Monitoring (CGM): An Evolving Regulatory Landscape
Live Webinar: Tuesday, October 25, at 2pm EDT
Continuous Glucose Monitoring (CGM) has the potential to become the new gold-standard in diabetes clinical trials. Listen as a panel of industry experts discuss CGM and upcoming regulatory challenges. Our panel includes Quintiles leader Sam Osman, Vice President of Clinical Development at Lexicon Pharmaceuticals Paul Strumph, Rich Bergenstal, and Richard Yang, VP of Corporate Sales & Connected Solutions of leading CGM manufacturer Dexcom.
Sponsor: QuintilesIMS
Vendor Overload? Integrating Third Party Lab Management to Streamline Clinical Development
Live Webinar: Thursday, October 27, 2016 at 11:00 AM EDT
As the complexity of clinical trials increases, pharma and biotech companies are spending more time managing multiple lab services providers from across the analytical spectrum, including genomics, bioanalytical, esoteric testing, biomarker, safety and more. From years of working with third party labs Q2 Solutions is sharing their approach and best practices for centralizing the management of third party vendors and improving the efficiency of clinical development.
Sponsor: Q2 Solutions
The Next Wave of Centralized Monitoring
Live Webinar: Thursday, November 10, 2016 at 11:00 AM EST
What if you could predict which of your subjects are likely to have adverse events in the next 3 months or which of your sites will be non-enrollers in the next 30 days? The latest release of QuintilesIMS’ centralized monitoring and predictive analytics capabilities can do just that. Learn how these break-through technologies can improve overall quality and patient safety in your studies.
Sponsor: QuintilesIMS
Drive Better Outcomes with Improved Trial Design
Live Webinar: Tuesday, December 6, 2016 11am – 12pm EDT
Today’s clinical development landscape is more expensive and complex than ever. Take this opportunity to learn from Quintiles leaders, armed with decades of clinical trial design and execution expertise, as they discuss these challenges and strategies to reduce costs and improve your probability of success.
Sponsor: QuintilesIMS


Regulatory Changes in India and What It Means for Clinical Research in the Country
Recorded DAte: October 19, 2016
Register to learn about the positive changes in the Indian clinical research environment and what this means for clinical trials in the country.
Sponsor: QuintilesIMS
Project Management in PV – an ICH E2B R3 and IDMP Case Study
Recorded Date: September 21, 2016
Do you understand the impact of the new pharmacovigilance and regulatory standards? How will your processes and procedures need to change? Can your current systems adapt to the new requirements? Learn how Quintiles is preparing to adapt to the new standards.
Sponsor: Quintiles
Transforming Patient Recruitment through Patient and Site Engagement
Recorded Date: August 23, 2016
11% of research sites industry-wide fail to enroll a single patient and 37% of sites under-enroll, wasting time and money that does not benefit sponsors. Bernadette Tosti, Senior Director of Patient Recruitment, Quintiles, will address the various ways Quintiles is pioneering early planning, forming new and innovative relationships, and using new technology and communication tools to create more effective physician networks with a focus on patient engagement.
Sponsor: Quintiles
Developing High Quality Biosimilar Products for Western Markets
On Demand Available through June 26, 2017
This seminar is designed primarily for Asian companies targeting biosimilar product registration in the West (e.g., U.S., EU and Canada).
The webinar will address 3 key areas:
  1. FDA/EMA regulatory expectations for biosimilars
  2. Reference products, including selection criteria and evaluation of critical quality attributes.
  3. Common errors in the development of biosimilar products, with tips on how to avoid wasting time and money – and the potential derailment of your biosimilar development program.
Register Free: 
Sponsor: Quintiles
The State of Risk-Based Monitoring (RBM)
Recorded Date: June 21, 2016
Risk-based monitoring (RBM) is disrupting clinical development on every level. Hear experts explain the challenges faced in implementing RBM studies and the latest technology capabilities to help you execute your studies with confidence.
Sponsored by: Quintiles
BioVisualization: Effective Mining and Interpretation of Laboratory Results Data
Recorded Date: May 26, 2016
In this webinar, we discuss:
 - Next-generation data management tools and services and how they are changing how researchers are able to interpret intricate data and make better informed decisions
 - How a versatile biovisualization platform can enable effective data mining and ease of interpretation
 - Biovisualization as a viable way to free up in-house staff to work on development and research rather than data analysis
Sponsor: LabConnect
ICH E6 (R2) - Process and Technology Considerations for the New Risk Based Gold Standard
Recorded Date: May 12, 2016
Understand how ICH E6 (R2) guidelines will impact your organization and how Risk Based Monitoring is just one component of a successful risk-based approach to clinical conduct.
Sponsor: ERT
Keeping Pace with Immuno-Oncology Research Breakthroughs and Biomarker Identification
Recorded Date: May 4, 2016
The excitement surrounding immuno-oncology is being driven by results seen in the clinic. New treatments can potentially be made more efficacious using NGS technology that would accelerate biomarker identification and bring down costs for research subject screening and safety monitoring. Among these technologies is RNA-Seq, a flexible sequencing assay that enables multiple applications with one assay from a single sample. In this webinar, we’ll summarize the clinical relevance of RNA-Seq, when and how to use expression profiling economically, some common challenges and associated remedies.
Sponsor: Illumina & Q2 Solutions
From Eligibility to Exploratory: Planning and Implementing Biomarker Testing for Immuno-Oncology trials
Recorded Date: April 27, 2016
To harness power of Immuno-oncology, a deep understanding of the intricate workings of the anti-tumor immune response is required. With mechanisms still partially veiled and hypotheses emerging from all angles, one thing is clear –Immuno-oncology is complex and these trials have brought new challenges to all corners of drug development, including clinical biomarker testing. In this webinar, scientists from Q2 Solutions will highlight some of the particular challenges associated with the diverse clinical biomarker requirements of Immuno-oncology trials and discuss how our laboratories have worked with Pharma clients to bring key research tools- anatomic pathology, flow cytometry, and genomics- into Immuno-oncology clinical trials and the potential development of companion diagnostics.
Sponsor: Q2 Solutions
Immuno-Oncology Insights: Top 5 Challenges in Today’s Immuno-Oncology Trials
Recorded Date: April 7, 2016
Immunotherapy is one of the most promising avenues of research in the battle against cancer. As initial checkpoint inhibitors come to market, the immuno-oncology development landscape is exploding. Now, the pressure is on to apply insights from existing studies to ensure future trials are quick and efficient, yield high-quality data, and assure patient safety.
Sponsored By: Quintiles
Overcoming Regulatory and Statistical Hurdles of Biosimilars Drug Development: Designing Smarter Trials
Recorded Date: April 6, 2016
Before you consider putting your biosimilar drug through development, you need to be informed of the regulatory pathways and complexities that will be involved – as well as steps you should take to address these regulatory considerations for making important decisions about your biosimilar products.

Register Free: www.appliedclinicaltrialsonline.com/act/biosimilars
Sponsored By: Quintiles

Mitigating Risk Using Risk-Based Monitoring
Recorded Date: March 22, 2016

Learn how risk-based monitoring (RBM) is transforming clinical development by mitigating risk while optimizing execution. Understand how to achieve enhanced patient safety with improved quality to execute your RBM studies with confidence.

Sponsored By: Quintiles
Acquiring, Tracking and Maintaining Biological Study Samples for Complex Study Designs
Recorded Date: March 17, 2016
More than sample tracking, it is piece of mind. Having confidence that you can start the sample management and tracking process before a sample is collected and follow it on the day of collection throughout the sample’s lifecycle yields a real-time, higher quality view of your samples, subjects, and data allowing you to make informed decisions about your study direction much faster.

Register Free: www.appliedclinicaltrialsonline.com/act/labconnect
Sponsored By: LabConnect


Advancing Drug Development with Digital Health: 4 Key Ways to Integrate Patient-Generated Data into Trials
Recorded Date: March 16, 2016
Are you ready to advance drug development with digital health? Register for this webinar to hear Medidata and Validic discuss how you can start leveraging participant-generated data in four key areas to streamline trials.

Register Free: http://www.appliedclinicaltrialsonline.com/act/digitalhealth
Sponsored By: Validic


Introducing a Faster, Easier, and More Effective Approach to Risk-Based Monitoring
Recorded Date: March 15, 2016

Oracle Health Sciences’ holistic, advanced clinical trial solutions for data collection, management, and analysis help optimize research, mitigate risk, monitor/report adverse events, and drive medical insight for precision medicine.

Register Free: www.appliedclinicaltrialsonline.com/act/fastermonitoring
Sponsored By: Oracle Health Sciences


Advanced Visual Analytics for Efficient Risk-Based Monitoring
Recorded Date: December 10, 2015

This webinar will present how PerkinElmer's Solution for Clinical Development Operations—powered by TIBCO Spotfire®—is the ideal platform for RBM enabling optimal trial oversight through real-time risk assessment.

Register Free: www.appliedclinicaltrialsonline.com/act/visual
Sponsored By: PerkinElmer


Case Studies: Why Clinical Organizations are Going Beyond EDC and Embracing Clinical Data Management
Recorded Date: November 12, 2015

This webcast presents real-world, pragmatic case studies of how clinical organizations are effectively managing data disruption by going beyond the limitations of today's EDC technology and embracing integrated, end-to-end clinical data management – driving greater development efficiencies, increasing the speed and quality of clinical trial data and submissions, and reducing operational risk.

Register Free: www.appliedclinicaltrialsonline.com/act/edc
Sponsored By: Oracle Health Sciences


Clinical Trial Design & Analysis to Improve Assay Sensitivity
Recorded Date: Wednesday, October 28, 2015

Neuroscience studies are prone to high placebo effect, lending themselves well to alternative designs. Learn from PPD experts on how Trimentum™, or sequential parallel comparison design (SPCD), an alternative model for conducting clinical trials, compares and contrasts with other study design methodologies.

Register Free: www.appliedclinicaltrialsonline.com/act/NeuroStudies
Sponsored by: PPD


Overcoming Clinical Trial Challenges at Small and Mid-Sized Research Organizations
Recorded Date: October 14, 2015

During this webcast, we will hear from three organizations – world-renowned academic research organization and NCI consortium member Dana-Farber / Harvard Cancer Center, leading biotech Ophthotech, and innovative CRO Seaview Research. Each will present their challenges and valuable lessons learned of how to leverage eClinical solutions to optimize clinical trials while delivering high-quality data.

Register Free: www.appliedclinicaltrialsonline.com/act/industry
Sponsored By: Oracle Health Sciences


Clinical Endpoint Adjudication Strategies to Improve CEC Process Flow and Accurate Endpoint Review
Recorded Date: September 22, 2015

In this webcast, experts will explain how to run a successful clinical endpoint committee (CEC), as well as how to mitigate risks to adjudication and put the best processes in place to save time and costs.

Register free: www.appliedclinicaltrialsonline.com/act/CECprocess
Sponsored by: Chiltern


For questions or more information please contact Kristen Moore at [email protected].


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