November 3, 2016 - 2:00pm (EDT)

Optimize your supply chain and reduce your costs with Bioclinica Optimizer. Attend this 1 hour online workshop and have a coffee on us. Sign up today!

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)

Bridging the Gap: Managing and Maintaining CTMS and eTMF Data
In this webinar, clinical trial experts Dirk Beth of arivis, a Bioclinica App xChange Partner, and Bioclinica's Jeremiah Rehm will explore the possibilities of single source data across CTMS/eTMF systems. This approach can bring increased efficiencies in a number of important areas, such as elimination of redundant work processes and reconciliation of CTMS/eTMF data.

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

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

What Effect Does ICH E6 R2 Have on Risk-Based Monitoring and Overall Quality Risk Management?
With the aim of improving efficiencies in trial conduct while ensuring participant safety, regulatory guidelines have recently undergone revision. The revision to the ICH Guideline for Good Clinical Practice (E6 R2) primarily addresses quality management with a focus on risk identification, evaluation, control, review and reporting. With the pending adoption of these revised guidelines, it's time to evaluate how your organizational structure and processes will be affected.

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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Post-Approval Research

Patient Centric Post-Approval Research: It's Time to Rethink How Post-Approval Studies Are Done
With an evolving role and complexities of post-approval studies – and a shift toward patient centric outcomes – it is imperative that we revisit the way post-approval research is conducted.

Conducting Post-Approval Research Requires a Unique Mindset and Specialized Infrastructure. Do You Have What it Takes?
There are fundamental differences in conducting research in pre-market randomized controlled trials (RCT) versus post-approval. These differences are not only in the study intent and objectives but the operations and conduct.


Safety and Relgulatory Solutions

Cloud-Based Tool Aims to Improve Global Drug Safety & Regulatory Efficiencies While Remaining Compliant
Keeping up with the increasing and evolving safety and pharmacovigilance obligations around the globe can be a major challenge.

In this webinar, she will discuss upcoming changes in global drug safety regulatory requirements and will demonstrate how Bioclinica's drug safety regulatory intelligence tool, RITrace, can improve efficiencies and help you remain compliant.

Marketing Medicines in the EU - Pharmacovigilance Requirements
In this complimentary webinar the Chief Safety Advisor for Synowledge (a Bioclinica company) provides expert insight into good pharmacovigilance practices (GVP) modules within EU legislation. Any pharmaceutical company wishing to market products within the EU must be aware of their legal requirements under the legislation. This webinar is suitable for all staff working in the safety and regulatory area. It is an opportunity to gain an understanding of the legislation at a high level and ask specific questions relating to your business.

Finding the Right End-to-End Safety Solution for Your Needs
With upcoming changes, including the implementation of E2B(R3) and IDMP standards, the current state of safety reporting in clinical trials can be confusing. Your existing safety system may not be flexible enough to accommodate these changing regulations, which are still moving targets in the details needed for a comprehensive solution with the right level of processes, company-to-company integrations and finalized regional rules.


Financial Lifecycle Solutions

Clinical Trial Forecasting: Managing the Challenges and Avoiding the Fines
With globalization, large numbers of sites, recent regulatory requirements and an increasing number of CROs and vendors, clinical trials are constantly becoming more complex. Given that clinical trial costs are one of the biggest expense categories for biopharmaceutical companies—the average cost of bringing a drug to market in the US is estimated to be $1.3-1.7 billion—it's critical that CROs and Sponsors forecast accurately.

However, manual processes have made forecasting of clinical trials challenging, leading to difficulties in reforecasting and cash management (and as a result, difficulties in maintaining site satisfaction) as well as hefty fines.


Medical Imaging

Critical Regulatory Considerations for Imaging Trials: What You Need to Know
Medical Imaging plays a significant role in the conduct of clinical trials and bringing new therapies to market. However, as application of medical imaging in clinical studies grow, so does the complexity of regulations on a trial's conduct. The more sites, patients and modalities in a trial, the more complex the regulatory and workflow compliance.

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.

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Cardiac Safety

Recent Advances and Critical Review of The Intensive QT Study As a Replacement to The TQT Study: Are We There Yet?
In July 2013 the US FDA presented an initiative to replace the ICH-E14 mandated Thorough QT (TQT) study with a set of non-clinical assays, collectively termed 'Comprehensive In Vitro Pro-arrhythmia Assay' (CiPA). The non-clinical CiPA paradigm is complemented by an Early Phase cardiac safety assessment, involving routine Phase 1 single and multiple ascending dose (SAD/MAD) studies with intensive ECG (QT) and PK sampling, designated the Intensive QT (IQT) study.

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.

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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