Project Management in PV – an ICH E2B R3 and IDMP Case Study
Live Webinar: Wednesday, September 21, 2016 11am EDT – 12pm EDT
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

Drive Better Outcomes with Improved Trial Design
Live Webinar: Tuesday, September 27, 2016 11am EDT – 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: Quintiles

Transforming Patient Recruitment through Patient and Site Engagement
Live Webinar: Tuesday, August 23, 2016 11am EDT – 12pm EDT
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


The Impact of Risk-Based Monitoring on Site Performance
Recorded Date: September 16, 2015

Listen to risk-based monitoring experts and a leading Clinical Site discuss how RBM processes are engaging deeper site engagement while mitigating risk and improving patient safety.

Register free at: www.appliedclinicaltrialsonline.com/act/impact
Sponsored by: Quintiles


Using Predictive and Advanced Analytics to Enhance Risk-Based Monitoring
Recorded Date: September 3, 2015

Listen to risk-based monitoring experts highlight new capabilities further mitigating risk and improving patient safety using Predictive and Advanced Analytics.

Register free at: www.appliedclinicaltrialsonline.com/act/dte
Sponsored by: Quintiles


Veeva 2015 Paperless TMF Survey: Annual Report
Recorded Date: July 21, 2015

Hear results from the industry-wide Veeva 2015 Paperless TMF Survey. This annual survey analyzes the observations of TMF owners from around the globe to identify the barriers, business drivers, and benefits of moving to fully paperless TMFs.

Register free at: www.appliedclinicaltrialsonline.com/act/paperless
Sponsored by: Veeva


Embracing a Mobile Medical App in a Clinical Development Strategy to Improve Clinical Outcomes, Increase ROI and Lower Costs
Recorded Date: June 25, 2015

Dedicated patient monitoring devices as well as smartphones, tablets and other wireless devices are rapidly becoming part of modern clinical development strategies. In this presentation, you’ll learn about the benefits of mobile medical applications in clinical trials as well as their implementation challenges. 

Register free at: www.appliedclinicaltrialsonline.com/act/medicalapp
Sponsored by: Theorem Clinical Research


Benefits of Integrating Lab Data into Risk-based Monitoring Execution
Recorded Date: June 23, 2015 

Listen to risk-based monitoring experts explain the benefits of integrated lab data into your monitoring strategy.

Register free at: www.appliedclinicaltrialsonline.com/act/labdata
Sponsored by: Quintiles


eSource—Easier than you Think
Recorded Date: June 11, 2015 

This webinar will provide summary results from a comprehensive survey on eSource conducted by Applied Clinical Trials (in collaboration with OmniComm Systems). The presenters will highlight opportunities for adoption in the light of current regulatory guidance, the exciting confluence of eSource and Risk Based Monitoring initiatives, and specific technical approaches for gathering and managing eSource data. 

Register free at: www.appliedclinicaltrialsonline.com/act/esource
Sponsored by: Omnicomm


Optimize Clinical Trial Results Through Reliable Adherence Measurement
Recorded Date: June 9, 2015

Learn how adherence-informed clinical trials maximize patients’ exposure to the test drugs, simultaneously maximizing drug response and reducing its variance, and thus increasing statistical power. 

Register free at: www.appliedclinicaltrialsonline.com/act/adherence
Sponsored by: WestRock


Reducing the Risk of Phase III Failures
Recorded Date: June 4, 2015 

It is well documented that 50 percent of Late Phase clinical trials fail due to efficacy and/or safety reasons. The result is a tremendous financial burden to biopharmaceutical companies, the engagement of tens of thousands of patients participating in clinical studies to no avail, and significant time lost for patients looking for viable treatment options in numerous therapeutic areas.

Register free at:www.appliedclinicaltrialsonline.com/act/PhaseIIIRisk
Sponsored by: PAREXEL


Considerations for Formally Validating Software in Laboratories Supporting of CLIA Genomic Assays
Recorded Date: June 3, 2015 

Learn of important challenges and lessons in the CLIA validation of a large genomic oncology-focused assay from Dr. Vic Weigman, Associate Director of Translational Genomics at EA/Quintiles.  

Register free at: www.appliedclinicaltrialsonline.com/act/genomic2
Sponsored by: Quintiles


Demystifying Genomics for Drug Developers
Recorded Date: May 19, 2015 

With the US federal government now backing a Precision Medicine Initiative, genomics, personalized medicines, bioinformatics, and next-generation sequencing have stepped into the spotlight and become new buzzwords for drug developers. But what do all of these terms mean? In this webinar we will explore genomic applications to precision medicine programs and shed light on how genomics is transforming drug development.

Register free at: www.appliedclinicaltrialsonline.com/act/demystifying
Sponsored by: Quintiles


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


lorem ipsum