Please Wait...

Webinars

October 26, 2017 - 10:00am (EDT)

New drugs, biologics and devices in development today can be very effective at treating the targeted disease or condition. However, many may also have a negative impact on cardiovascular outcomes and therefore the review of clinical events need to be considered. This webinar will provide an overview of the centralized review of cardiovascular safety through implementation of a Clinical Events Committee (CEC) and the importance of collecting and adjudicating events and providing unbiased assessments through electronic expert evaluation. This presentation will highlight the role electronic expert evaluation plays in improving the quality of endpoint assessments for cardiovascular outcomes. A detailed discussion on the Clinical Event adjudication process workflow will be shared.

December 6, 2017 - 11:00am (EST)

Medical imaging is an integral part of managing cancer patients and in the evaluation of new therapies in clinical trials. This webinar will summarize and highlight the various types of imaging and their role in the clinic and in research, with a perspective on the regulatory aspects that govern its use and practical aspects for pharma, biotech and contract research organizations.

On Demand Webinars by Category

 

Electronic Data Capture (EDC) and Data Management

How Innovations in Data Visualization Are Accelerating Data Cleaning and Improving Quality
One of the most important milestones in any trial is database (DB) lock. A key step towards DB lock is tracking that all activities are completed and clean for each patient (coding, external data reconciliation, query status, etc.). This can often be a challenge, especially for studies with large amounts of data. How do you track these many disparate activities for each patient? How do you predict if you are on track to meet the planned DB lock? Is there an easy way to visualize the status of your study?

 

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)

Outsourcing to CROs? The Top 5 Reasons to Consider Bringing CTMS and Quality Management/RBM Systems in House
This webinar will focus on the changing landscape around outsourcing and key reasons why sponsors may wish to take a fresh look at relying solely on the CTMS and RBM systems of their CROs, especially in terms of efficiency. Come join our speakers as they explore the topic through case studies and look at ROI considerations associated with different outsourcing options, helping you decide an approach right for you.

 

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.

Back to Top

 

Randomization and Trial Supply Management (RTSM)

IRT Best Practices: How Companies are Accelerating Timelines While Improving Quality
This webinar will highlight the use of more innovative agile methodologies to achieve better project delivery predictability, streamlined processes and high quality studies. Through case studies, presenters will share insight into improving quality and reducing risk while accelerating timelines.

 

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.

 

Risk-Based Monitoring

Outsourcing to CROs? The Top 5 Reasons to Consider Bringing CTMS and Quality Management/RBM Systems in House
This webinar will focus on the changing landscape around outsourcing and key reasons why sponsors may wish to take a fresh look at relying solely on the CTMS and RBM systems of their CROs, especially in terms of efficiency. Come join our speakers as they explore the topic through case studies and look at ROI considerations associated with different outsourcing options, helping you decide an approach right for you.

 

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.

Back to Top

 

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

Outsourcing Pharmacovigilance: Pros and Cons and Lessons Learned
As the demand for new therapies increases, so does the need to comply with regulatory requirements across the pharmaceutical industry, which is on the constant lookout for newer, more efficient ways to tackle the ever increasing load of adverse event data. Sometimes the need is driven by a lack of availability of the necessary parts of the system to implement pharmacovigilance on time by first-time marketing authorization holders. Other times, it may be the need to streamline processes and reduce wastage by larger companies, in order to have a more robust and compliant reporting system. More and more companies are looking at outsourcing as a possible solution to their short or long term needs.

 

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 Payments Case Studies: Improving Efficiency, Cash Management, and Compliance
During this webinar, clinical financial experts from Bioclinica will present case studies of how trial sponsors and CROs are:

  • Automating the clinical payments process to improve accuracy and operational efficiency, while gaining greater control over cash management
  • Making accurate and timely financial decisions and projections based on relevant financial and operational data, including payment trends and accurate reforecasting based on trial actuals
  • Quickly and accurately calculating accruals to track current liabilities for payments
  • Providing increased transparency and advanced visibility to the payment process and forecasts for all stakeholders, streamlining reporting and Sunshine Act compliance
  • Increasing site satisfaction and becoming high-performing sites' "partner of choice" by replacing error-prone, manual methods with fast and accurate data-driven processes

 

How Improving Site Payments Can Make You the Sponsor/CRO of Choice
In a 2016 CenterWatch survey of 252 global investigative sites, the organization found that "e-clinical technologies are increasing investigative site work burden and performance inefficiencies." With investigative sites under increasing resource constraints, they are becoming far more selective in the companies they choose to do business with.

One of the top selection criteria that clinical sites use to make this determination is whether the sponsor or CRO delivers timely and accurate payments for contracted activities.

 

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

Lugano 2014 Criteria for Assessing FDG-PET/CT in Lymphoma: An Operational Approach for Clinical Trials
This presentation will include a detailed discussion of a number of workflow paradigms for the implementation of the Lugano 2014 assessment in oncology clinical trials. This discussion will also include the use of PET/CT quantitative measurements and the five point scale along with the validation of these approaches to further objectify reader interpretation. The components highlighted in the proposed workflow and discussion points in this webinar are intended to help achieve more uniform and consistent multi-time point imaging assessments in lymphoma clinical trials.

 

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.

Back to Top

 

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.

Back to Top

LEARN MORE OR SPEAK WITH OUR EXPERTS

CONTACT US
Leader in Clinical Trial
Management Solutions

Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

RT @bioclinica: Attending CBI's IRT conf? Catch 10/27 @bioclinica GSK talk on bens of sponsor controlled #IRT. Here's the core tech https:…
bioclinica (3 days ago)
RT @Xtalks: Clinical Event Adjudication: Comprehensive and Efficient Dossier Review Using a Global On-Line Solution @bioclinica https://t.c…
bioclinica (3 days ago)
RT @eClinical_Jen: Good Morning from NJ! @bioclinica is a sponsor of the clinical supply show because we have awesome supply forcasting and…
bioclinica (4 days ago)
Attending CBI's IRT conf? Catch 10/27 @bioclinica GSK talk on bens of sponsor controlled #IRT. Here's the core tech… https://t.co/zFiQswIQFb
bioclinica (5 days ago)
RT @Xtalks: #Cardiovascular Imaging for Monitoring Safety: Visualizing Outcomes @bioclinica https://t.co/5osqBkDFKm
bioclinica (5 days ago)
Want stellar imaging acquisition & assessment in your #clinicaltrial ? Get tips in @bioclinica 's Tim Crowe's blog https://t.co/hzbV3Cmlyc
bioclinica (6 days ago)

Latest Blogs: