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.
Clinical 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.
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Randomization and Trial Supply Management (RTSM)
Agile IRT is here! How can you benefit?
Bioclinica experts will show how evolved software development is being applied to IRT study builds to bring about better timelines, visibility and – most importantly – quality. Participants will find out how leading pharma organizations are already employing live study demos and feedback loops, and as a result, experiencing significant advantages of Agile IRT over conventional IRT build – in many important and unexpected ways.
What Value Does Forecasting and Demand Planning Technology Bring to the Management of the End-to-end Clinical Supply Chain?
Forecasting and demand planning tools provide insight to what is truly happening in a clinical trial. They give the transparency required to make timely and educated decisions with regards to clinical trial supply plans and connect people and processes to streamline the forecasting, planning and optimization of the supply chain.
ICH E6 R2 - Guidance and Road Map of Tools for Navigating the Regulatory Landscape
ICH E6 R2 may be relatively new, but the team at The Avoca Quality Consortium (AQC) has been working on many of the components of this set of regulatory changes for over five years.
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.
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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.
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.
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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.
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