December 9, 2015 - 11:00am (EST)

Transformative Digital Health Technologies for Patient Engagement and Reporting in Clinical Trials

Get up-to-speed on the most promising consumer-type and patient-centered applications and devices that are beginning to drive a revolution in research. See how these applications can be employed – effectively extending your eClinical platform – and the cost-savings they can bring. Find out how to safely and securely integrate point of care, patient engagement, workflow, source data, safety and other apps within your clinical trials.

On Demand Webinars by Category


Electronic Data Capture (EDC) and Data Management

CDISC Standards Briefing – Get Ready for FDA Submissions
Join Jennifer in this webinar for a detailed briefing on where we stand with CDISC implementation and what's next. Learn about recent activities surrounding CDISC standards, which support the acquisition, exchange, submission and archive of clinical research data and metadata and are accessed in 90 countries.

Primer for Data Managers on 2013 FDA Guidance and Regulations in an Age of eClinical Innovation
Between regulatory concerns and eClinical innovations how can clinical data managers make sense of it all? How do the 2013 FDA guidance and industry initiatives really impact your role? How do eClinical technologies support the FDA’s preferred monitoring methods, which include centralized monitoring and reduced Source Documentation Verification (SDV)?

Risk-Based Monitoring and Related Initiatives – A Data Management Professional’s Perspective
Risk-based monitoring is one of the hottest topics in the clinical trial management sector, with the pharmaceutical consortium, TransCelerate BioPharma, leading the conversation. There are other organizations, such as the Critical Path Institute (CPI) and the Clinical Trials Transformation Initiative (CTTI) that are working towards groundbreaking industry change initiates as well.

The New FDA Draft Guidances – What it means to me as a Site, a CRA and a Data Manager
The FDA has recently issued draft guidances for Industry on Standards for Clinical eSource and Risk-Based Approaches to monitoring which have a broad impact on almost all facets of the clinical trial management. This webinar series will discuss the impact of recent FDA guidances on industry and approaches to prepare to implement new strategies.

Keeping Current with Coding – The Upversioning Approach
Keeping up with medical coding standards is an important part of ensuring clean clinical trial data. This webinar will cover reasons and strategies for upgrading both MedDRA and WHODrug dictionary coding. We will discuss both internal and external tools to assist with the recoding of medical data, including the BioClinica Autoencoder Dictionary Migration (available in Express 5.2) and the MVAT (MedDRA Version Analysis Tool).

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Trial Management Systems (CTMS)

CTMS/eTMF Interoperability: Taking Clinical Trial Data beyond Documents
In this webinar, clinical trial experts Sharon Ames and Jeremiah Rehm will explore the real possibilities of single source data across Clinical Trial Management Systems (CTMS) and Electronic Trial Master Files (eTMF).

Being OnPoint with SharePoint
This webinar will explore the origins and current trends towards Clinical Trial Management Systems (CTMS) in an effort to help participants make more informed technology choices. While any good CTMS is a significant improvement over paper-based processes, the right selection will provide the automation needed to streamline trial logistics as well as help your organization save time and money.

Site Monitoring Made Easier: The Microsoft Office Connection
While site monitoring will never be easy, it can certainly be easier! The BioClinica OnPoint Clinical Trial Management System is a site monitoring solution that maximizes the functionality of Microsoft Office products such as Outlook, Word, and Excel; which are already being used by site monitors. This allows both managers and monitors to work with site visit reports, calendars, contact records, and action items directly within familiar software without requiring them to learn a new CTMS or transcribe information into that system – with or without an internet connection!

The Capabilities of SharePoint for Clinical Trial Operations
Les Jordan, CTO, Life Sciences Industry Unit at Microsoft, will explain how SharePoint helps companies to manage their clinical operational data, to collect more timely information, and to make more informed decisions.

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Interactive Voice Response (IRT) and Patient Randomization

Preventing Drug Shortages in Clinical Trials
With so much riding on clinical supplies, preventing drug shortages and their cascade effects on clinical trials is important.

IRT: More Gain, Less Pain - Is IRT Technology Transfer Right for You?
Join this webinar and hear about different IRT sourcing models − the traditional IRT software approach and IRT technology transfer – and find out what level of control in studies is right for you.

Modern Randomization: A Sampling of Current Schemes using IRTs
Patient randomization is critical to running all blinded clinical trials, but not all randomization methods can meet the needs of modern studies. Complex protocols that include multiple treatment arms, adaptive designs, and inconsistent allocation ratios require advanced interactive response technology (IRT) randomization engines for proper trial execution. This increased statistical power brings with it a higher risk of error and can impact drug supply predictability, making it more important than ever to find the right IRT system for your trial.

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Leveraging eClinical Technology Suites

Using Metrics to Measure the Health of Your Clinical Trials
This webinar will show you how to leverage the data from your various eClinical systems to create eye-opening performance metrics. Participants will also learn how easy it can be to quickly assess the health of your studies and identify and address problem areas early for overall improved quality and performance.

No Subject Left Behind! Supply Chain Forecasting after First Patient In
Many companies use forecasting tools to determine their initial shipping plans, but there are big benefits of continuing to forecast as the trial progresses. In this excerpt from a recent BioClinica Trial Blazers Roundtable discussion, clinical trial supplies expert Buz Hillman shares some of the benefits of forecasting and fine tuning the supplies plan with actuals data.

Top 10 Ways to Ensure Your eClinical Technology Meets FDA Guidelines
There is no denying that technology has the ability to make the clinical trial process run more efficiently. Interactive Response Technology (IRT), Electronic Data Capture (EDC), and Clinical Trial Management Systems (CTMS) can help manage every part of a trial including supply chain management, subject randomization, payments (a hot topic under the Affordable Care Act), and data management.

Top 10 Ways to Make Clinical Trial Management Easier and More Efficient
Having a successful clinical trial takes significant up-front planning that begins long before First Patient In. Study planners face many challenges, from locating qualified investigators and ensuring clean data collection to managing the supply chain and making the correct regulatory submissions. If you're struggling to address any of these, this webinar is for you.

Clinical Research Standards and Guidances: Implications for eClinical Technology
The complexity involved in the design and implementation of clinical research technology can be daunting. There are many factors to consider in assuring the correct data is captured to determine a successful outcome, and assuring that information is collected according to certain regulatory guidelines. In addition, the study must be designed using data standards to ensure optimal submission to the regulatory agency. These data standards are vital to improving the way clinical trial information is managed, interpreted, and shared.

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Risk-Based Monitoring

RBM-Enabling Technology: Analytics with Action
In this webinar participants will explore technology considerations in depth with Trevor McCaw, co-developer of BioClinica's Compass intelligent monitoring solution. Trevor will explain how to tell if an RBM tool is truly framed around risk and quality principles using Compass as a demonstration platform.

Successful Application of Intelligent Monitoring Tools in Data Management
Risk based monitoring (RBM) and reduced source document verification (rSDV) offer new approaches to running better clinical trials, making them two of today’s most talked about topics among research organizations. The conversation however should not end there…the role of data management is more important than ever.

Overcoming Barriers to Risk Based Monitoring
Risk-Based Monitoring offers an amazing opportunity, but there are many companies that are hesitant to undertake such an initiative. In this interactive webinar, experts Mireille Zerola and Courtney McBean will discuss common challenges organizations face when transitioning to risk based monitoring and ways to overcome these obstacles.

An Intelligent Approach to Risk-Based Monitoring
Many pharmaceutical companies are excited by the promise of Risk-Based Monitoring, but are uncertain as to how to implement such an initiative. In this exciting presentation, Courtney McBean will discuss the core principles of Risk-Based Monitoring and the key steps to Implementing an RBM program that goes beyond reducing site visits and instills a greater focus on quality in clinical trials.

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Medical Imaging

Leveraging Biomarkers To Improve Return On Investment In Drug Development
Diminishing returns on investments have plagued the pharmaceutical industry over the last decade. This webinar will explore the increased use of biomarkers for increasing ROI, by facilitating earlier "no-go" clinical trial decisions, improving the likelihood of successful clinical trial outcomes, and accelerating drug development timelines.

Innovative Strategies for Developing Safer Cancer Therapies
The emerging clinical discipline of 'Cardio-Oncology' aims to promote safer drugs and better outcomes for cancer patients through the use of multimodal strategies for assessing drug-dependent cardiac abnormalities. In this webinar, experts will highlight state-of-the-art approaches and key considerations for establishing successful cardiovascular safety strategies for oncology clinical trials.

Monitoring Skeletal Integrity in Clinical Trials for Safer Diabetes Therapies: Lessons Learned From Recent FDA Approvals
This webinar will focus on clinical trial imaging endpoints for monitoring skeletal health in safety studies with an emphasis on novel endpoints for fracture risk assessment in clinical trials for Diabetes.

Challenges for Skin Cancer Clinical Trials: Assessments using RECIST 1.1
As the incidence of skin cancer continues to rise, scientists and clinicians are working to develop targeted treatments, many of which will enter clinical trials to evaluate their therapeutic efficacy. Recent clinical trials for skin cancer incorporate the use of RECIST 1.1 (Response Evaluation Criteria in Solid Tumors), a set of standardized 'rules' used in clinical trials to formally evaluate a patient's response to therapy. RECIST 1.1 builds upon the original RECIST criteria and involves the physical measurement of target and non-target lesions over time using imaging modalities like CT and MRI.

Best Practices for Managing and Processing Imaging Data in your Clinical Trial
Clinical Data Management (CDM) is a critical part of clinical research, leading to the generation of high-quality, reliable, and statistically sound data from clinical trials in support of new drug and medical device approvals.

Independent Review for Imaging-Based Clinical Trials
Independent review of medical images is one of the most important steps in an imaging-based clinical trial. Imaging Core Labs exist to meet the demand for radiological reads as well as facilitating the acquisition and processing. For many of the processes employed there has been minimal documentation in the scientific literature to support the methodologies. This webinar will present read methodology and design as part of the detailing of the clinical trials.

New Strategies to Expedite Go/No Go Decisions in Oncology Trials
Ronald L. Van Heertum, MD will speak on the benefits of utilizing molecular imaging in early phase oncology clinical trials and how the use of FDG PET and other molecular imaging modalities can expedite critical go/no go decisions.

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Cardiac Safety

Innovative Strategies for Developing Safer Cancer Therapies
The emerging clinical discipline of 'Cardio-Oncology' aims to promote safer drugs and better outcomes for cancer patients through the use of multimodal strategies for assessing drug-dependent cardiac abnormalities. In this webinar, experts will highlight state-of-the-art approaches and key considerations for establishing successful cardiovascular safety strategies for oncology clinical trials.

Advanced Hemodynamic Monitoring for Clinical Trials - Safety and Efficacy Endpoints
Brachial blood pressure endpoints using auscultatory or oscillometric measures continue to be a cornerstone of clinical practice and pharmaceutical clinical research. Advances in technology are facilitating alternative hemodynamic measures, including Pulse Wave Velocity (PWV) and central pressures. These clinical endpoints provide valuable safety and efficacy data for drugs in development and offer key insight into cardiovascular disease progression and management.

Advancing Remote Cardiovascular Safety: Enhanced Blood Pressure Monitoring for Clinical Trials
Within clinical practice and clinical research, blood pressure is a well-recognized diagnostic endpoint for evaluating the efficacy and safety of a drug in development or already on the market. Blood pressure (BP) data can be captured with a number of technologies dependent on the sponsor's needs, the phase of the trial and the defined clinical endpoint. Advances in technology are facilitating the acquisition of comprehensive and accurate BP datasets in clinical studies. Sponsors now have several choices which fall on a continuum including centralized automated office BP, ambulatory blood pressure monitoring (ABPM) and home BP monitoring.

Blood Pressure as a Cardiac Safety Endpoint: Safety, Clinical R&D, and Regulatory Considerations
There has been an increased interest and focus from a regulatory perspective on the off-target blood pressure effects of compounds in development. This has led to a number of key considerations from regulatory agencies and drug sponsors related to blood pressure monitoring as a component of cardiac safety profiles and benefit/risk assessment across a range of therapeutic areas and drug classes.

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