On Demand Webinars by Category
Electronic Data Capture (EDC) and Data Management
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)
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
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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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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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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