Clinical, Regulatory and Commercialization Strategies for Rare Diseases
Live Webcast: Thursday, May 16, 2013; 10:00 AM EDT
What clinical, regulatory and commercial strategies can be designed and executed for optimal development of orphan drugs? This webinar will present strategies for and benefits of implementing clinical studies, registries and expanded access programs that can be conducted during the product lifecycle of an orphan drug.
Register Free at www.appliedclinicaltrialsonline.com/strategies
EU PV Changes to PSURs & Strategies for Benefit-Risk Analysis
Live Webcast: Wednesday, May 29, 2013; 8:00 AM PDT;11:00 AM EDT; 16:00 BST; 17:00 CEDT
PSURs have been revised as per the new EU Pharmacovigilance legislation. One of the major changes is the introduction of a systematic benefit-risk assessment section. Attend this webinar to learn about the PSUR and be in compliance with the new EU PV legislation.
Register Free at www.appliedclinicaltrialsonline.com/PSURs
New Strategies to Expedite Go/No Decisions in Oncology Trials
Live Webcast: Thursday, June 13, 2013; 10:00 AM EDT
Discover the critical role of molecular imaging in successful oncology drug development. Case studies will be utilized to demonstrate the importance of employing standardized techniques with FDG PET and other imaging modalities to ensure optimum results, expedite crucial study decisions, and successfully achieve early indicators for future cancer drug success.
Register Free at www.appliedclinicaltrialsonline.com/future
Sponsor: BioClinica Inc.
ON-DEMANDS NOW AVAILABLE FOR REPLAY
How Innovative Outsourcers are Succeeding at Virtual Trial Management
Recorded on: Wednesday, May 8, 2013; 11:00 AM EDT
R&D leaders across the life science industry are evaluating how to outsource more effectively, and for less than it cost five years ago. Marcus Thornton, Medidata Solutions and Henry Levy, Accenture will explore how to operationalize collaboration between sponsors and CROs using advanced technology.
Register Free at www.appliedclinicaltrialsonline.com/experience
IRT & EDC – Are You Ready for the Unified Experience?
Recorded on: Wednesday, May 1, 2013; 11:00 AM EDT
Join this session to hear insights from the IRT, EDC and vendor perspectives that will both describe the unified experience – for both sponsors and sites – and help facilitate the transition enabling organizations to successfully realize the vision.
Register Free at www.appliedclinicaltrialsonline.com/innovative
Editors' Series: The Why and How of Social Media for Clinical Trial Professionals
Recorded on: Tuesday, April 2, 2013; 11:00 AM EDT
Applied Clinical Trials recently surveyed its audience on how it uses social media and found that a majority aren't clear on its benefits; find it distracting or overwhelming; or don't want to use it for professional purposes. If you too have similar thoughts about social media, then this webcast is for you!
Social media--including LinkedIn, Twitter, Facebook, blogs and other--is growing in people's personal life, but how can you use it effectively for your work? This educational webcast is designed for anyone in clinical research who wants to find out how to use social media more effectively for professional purposes. We will focus mainly on LinkedIn and Twitter. Our socially-media savvy presenters will discuss the value of social media for clinical trials professionals, how to approach it for your specific needs, and how to manage it effectively.
We are taking advance questions and input @trialsonline on Twitter.
Register Free at www.appliedclinicaltrialsonline.com/socialmedia
Forecasting and Budgeting Metrics and Best Practices
Recorded on: Thursday, April 4, 2013; 11:00 AM EDT
With harsh financial environments, limited budgets and resources, companies are required to do a better job of forecasting, budgeting, and planning clinical trials. Join Ken Getz from the Tufts Center for the Study of Drug Development, and Andy Grygiel from Oracle Health Sciences for a complimentary webcast where industry challenges, trends, and best practices will be discussed.
Register Free at www.appliedclinicaltrialsonline.com/forecasting
Integrating Cloud-Enabled Clinical Support Systems Using Modern Technology & Standards
Recorded on: March 26, 2013
Integrated eClinical holds the key to reducing the costs and complexities associated with clinical research activity-regardless of the different vendor or internal systems involved. This webinar explores how modern technology combined with industry standards such as CDISC can be leveraged by solution providers to enable sponsors to achieve end-to-end clinical trial process support.
Register Free at www.appliedclinicaltrialsonline.com//integrating
Parkinson's Disease Update: Impact of Non-motor Symptoms on Diagnosis, Treatment and Clinical Trials
Recorded on: March 25, 2013
This webinar will feature an internationally-acknowledged expert in Movement Disorders who will introduce the field of NMS and then demonstrate its role in clinical trials for new treatment options in Parkinson’s. New data will be presented outlining how NMS alone or specific patterns of symptoms can contribute to the diagnosis of early Parkinson’s which enables a completely new perspective on prevention strategies (delayed onset) and related drug trials in this neurodegenerative disease.
Register Free at www.appliedclinicaltrialsonline.com/parkinsonsdisease
Incorporating Adaptive Trial Design Approaches in Oncology Clinical Trials
Recorded on: November 15, 2012
This webinar will analyze the incorporation of adaptive trial design in oncology trials, assessing the early decision making benefits that are critical to the decreasing drug development time and providing increased benefit to patients. Adaptive trial design is critical in all phases of oncology drug development and helps overcome many of the hurdles of traditional study design.
Join PPD’s Dirk Reitsma , M.D., Vice President, Global Product Development and Niklas Morton, Vice President, Global Biostatistics and Programming for an engaging and thought provoking look at the next generation of oncology clinical research. They will be joined by Scott Berry, Ph.D., President and Senior Statistical Scientist with Berry Consultants to discuss the statistical component of adaptive trial design and how it can benefit clinical trials.
Register Free at www.appliedclinicaltrialsonline.com/trials
Changing the Face of Clinical Development
Recorded on: November 14, 2012
Join the conversation as industry leaders discuss current challenges in clinical development and explore strategies for utilizing information and analytic insights to ensure future success.
The increasing globalization of clinical research means that information must be securely available and accessible across geographical boundaries. The ability to share information and collaborate globally with partners, business units or regulatory agencies is becoming a critical success factor for the life sciences industry. Companies that are able to securely share information and collaborate more effectively will have a significant competitive advantage over their competition.
Register Free at www.appliedclinicaltrialsonline.com/changing
Improving Clinical Operations with Digital Signatures
Recorded on: November 13, 2012
In the highly collaborative clinical trials ecosystem, a huge portion of all internally- and externally-generated documentation needs to be securely exchanged and then quickly signed, before being submitted to the regulatory authorities. By moving from slow, inefficient, and costly paper-based processes to an automated digital signature solution, clinical research organizations can significantly shorten
processing times, enable secure electronic processes, and support compliance with even the strictest of regulations.
Register Free at www.appliedclinicaltrialsonline.com/digitalsignatures
International Real World Post-marketing Studies that Involve Patient Intervention
Recorded on: October 24, 2012
There is an increasing demand for real world information from pharmaceutical payers and international regulatory agencies. Generally these studies only collect data available as part of routine clinical practice. However, the sponsors of these studies can gain substantial additional information on their patients in a real world setting by collecting additional data from patients including quality of life, patient satisfaction and other patient reported outcomes. In addition, with the increasing advance of gene testing in therapy choice, sponsors may also benefit from collection and storage of biological material from patients.
Register Free at www.appliedclinicaltrialsonline.com/patient
Best Practices for Biosimilar Development Programs
Recorded on: September 25, 2012
Clinical development biosimilars poses a new set of challenges but at the same time is firmly rooted in traditional practices used for large molecules such as proteins and antibodies. The regulatory framework for biosimilars is new and depending on the geographic area where marketing approval is sought, it may still be an evolving framework of rules that is not entirely defined. Planning of a biosimilar program and trial design will be streamlined as compared to a traditional drug development path to registration.
Register Free at www.appliedclinicaltrialsonline.com/bestpractices
Assessing Drug Effectiveness in Observational Studies using PROs
Recorded on: September 19, 2012
This webinar will discuss the new post-marketing study requirements by regulatory and health care payer, the use of patient reported outcomes to obtain data on real world drug effectiveness , and the appropriate selection process for specific PROs to address the following domains of real world effectiveness as reported by patients: treatment satisfaction, health care utilization, QOL, symptom assessment, tolerability, compliance, and safety.
Register Free at www.appliedclinicaltrialsonline.com/drugeffectiveness
Early Phase Development of Biologics:
Regulation, Biomarkers, Recruitment and Phase I Clinical Trial Considerations
Recorded on: September 18, 2012
Biologics are increasingly important in drug development today as they include the latest generations of targeted therapies based on recombinant therapeutic proteins, gene therapies, monoclonal antibodies — those treatments that use some form of recombinant technology in how these products were developed.
Register Free at www.appliedclinicaltrialsonline.com/biologics
Optimizing Site Performance Using An Evidence Based Site Selection Process
Getting the right results from a clinical trial starts with choosing the right investigative sites. Unfortunately, traditional approaches for finding clinical investigators have not been effective in identifying high performing sites, with 30 to 70 percent of sites failing to deliver even a single patient. A significant opportunity exists to improve enrollment performance by looking at historical performance and capabilities of sites. Join us in discussing best practices for world-class site selection used by industry thought leaders.
Recorded on: September 13, 2012 at 1:00 PM EDT
Register Free at www.appliedclinicaltrialsonline.com/selectionprocess
New Strategies for Clinical Trial Designs in Early Alzheimer's Disease and Mild Cognitive Impairment
Recorded on: July 31, 2012 at 11:00 AM EDT
This webinar will introduce and analyze new strategies for prodromal Alzheimer’s disease (AD) and mild cognitive impairment (MCI) clinical trials as well as trials targeting asymptomatic/biomarker positive populations.
Dr. Jeffrey Cummings, Director of the Cleveland Clinic Lou Ruvo Center for Brain Health, will be sharing his in-depth knowledge on the latest developments in outcome strategies, including patient population selection, single outcomes and the role of biomarkers.
Dr. John Harrison of Metis Cognition Ltd. and Imperial College, London, will provide his insights on best practices for cognitive assessment in patients of different disease severity. This will be followed by a brief outline of practical operational implementation of these strategies by Dr. Piotr Chaba, executive director, project management, PPD.
This webinar will take place on 31 July and will include the latest data and developments from the Alzheimer's Association International Conference (AAIC).
Register Free at www.appliedclinicaltrialsonline.com/cognitiveimpairment
How to Improve Your Clinical Trial Agreements
Recorded on: June 14, 2012 at 11:00 AM EDT
Clinical Trial Agreements are one area of the clinical trials start-up process that can create major delays and budget problems. If the CTA is structured properly upfront, and negotiated properly, these delays as well as budgetary, legal and contractual issues can be avoided down the line. This webinar will include the latest results of an Applied Clinical Trials survey on Clinical Trial Agreements; strategies toward streamlining these contracts for efficiencies; and best ways to negotiate and structure Clinical Trials Agreements.
Register Free at http://www.appliedclinicaltrialsonline.com/improve
Applied Clinical Trials
Driving Innovation in Clinical R&D Through Actionable Analytics
Recorded on: June 13, 2012
Successful innovation in Research and Development is critical to success in today?s life sciences market. There is growing realization of the potential for advanced analytics to improve and transform the end-to-end process of clinical trials and drug development. There is also confusion in the market surrounding the meaning and purpose of advanced analytics and how to apply analytics to fundamentally improve the clinical research process. In this webcast, industry thought leaders will discuss the potential for advanced analytics and explore ways to apply analytics to drive innovation throughout the clinical trials process. In order to survive and thrive in a challenging business environment, life sciences companies need the ability to quickly develop and deliver actionable analytic insights, knowledge and information to a broad array of business and scientific decision makers in the right format for easy consumption and at the right time. Some progressive, innovative applications of advanced analytics include those that focus on optimizing clinical trials, sometimes referred to as Clinical Trial Optimization. The ability to apply advanced analytics to areas like trial design, site selection, site monitoring, patient recruitment and retention, clinical supplies forecasting, and resource management, among others will foster the innovation necessary to accelerate drug development.
Register Free at www.appliedclinicaltrialsonline.com/clinicalr&d
On the Sunny Side of the Street: Transforming Site Contracting, Management and Payment
Recorded on: June 12, 2012
On the Sunny Side of the Street: Transforming Site Contracting, Management and Payment.
Sponsors, CROs and sites form the crucial nexus of clinical research. Yet at this critical intersection, there are roadblocks hampering the cooperation, coordination and smooth flow of information and data essential to delivering the research results that mark progress. Just the core act of contracting with sites has been shown to be a major bottleneck, while sites often experience monthly delays in payments as paperwork is completed. Furthermore, The Sunshine Act creates new work and concern as financial transparency is added to the burden for all.
Join us for this complimentary webinar in which industry leaders envision a better future for site contracting, management and payment, and discuss solutions that help to streamline currently difficult processes.
Register Free at www.appliedclinicaltrialsonline.com/transform
Prepare your Organization Today to Address the New EU PV Legislation
Recorded on: June 6, 2012
With new pharmacovigilance legislation taking effect in July across the European Union (EU), sponsors have been ramping up to address the requirements, but confusion still remains. Of the 16 guidance modules the EMA has planned to issue on Good Pharmacovigilance Practices, only seven draft modules have been released. These seven are promised to be finalized prior to the July deadline.
This webinar will update the audience on the current status of the legislation; what has changed in the EU PV landscape since our last webinar on this topic in September 2011; what sponsors are doing to address the confusion and challenges; and offer strategies that attendees can consider in their own companies.
Register Free at www.appliedclinicaltrialsonline.com/EUPV
The Capabilities of SharePoint for Clinical Trial Operations
Recorded on: June 5, 2012
Microsoft SharePoint is widely deployed in life sciences companies and already transforming the clinical trials landscape. Why is it the fastest growing product in Microsoft's history? SharePoint enables tight collaboration between and within research teams by easing document sharing and consolidating reporting. When used in a CTMS environment, biopharmaceutical companies can experience quantum leaps in operational productivity.
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.
Jeremiah Rehm, eClinical solutions specialist for BioClinica, will focus on specific benefits that life sciences companies have realized by surfacing clinical operations data from CTMS through SharePoint, and how they extend access to Microsoft Office applications for improved data visibility and control. Jeremiah will present a case study using this approach to address site monitoring challenges. By connecting CTMS to Microsoft SharePoint and Outlook, sponsors have facilitated offline data entry, standardized site visit report templates, and improved tracking and measuring performance.
Register Free at www.appliedclinicaltrialsonline.com/sharepoint2
EDITORS' SERIES: Top of Mind for Clinical Development Operations
Recorded on: May 23, 2012
Changes in the drug development landscape start at the top and have landed squarely in the hands of the clinical operations departments. From these high-level changes, directors, associate directors, project managers and more are sorting through the decisions needed to ensure the success and timely delivery of their clinical programs.
The presentations are based on original market research and one-on-one interviews with clinical operations executives present for an exclusive roundtable event discussing Clinical Development Operations issues.
This webcast panel will discuss the current issues pressing clinical development operations, how pharmaceutical companies perceive and select their CRO partners, and offer insight into what small, mid- and large-sized pharma executives are concerned with right now.
Register Free at www.appliedclinicaltrialsonline.com/mind
Applied Clinical Trials
Complex Expiry Date Management via IVR/IWR
Recorded on: May 22, 2012
Investigational product (IP), especially when working with a product that has many shipments and a short shelf life, can make managing expiry dates a complex affair. Nicole Graves, Director, Client Services at Bracket, will explore inventory management via IVR/IWR system, focusing on expiry management and its unique capabilities.
Register Free at www.appliedclinicaltrialsonline.com/expiry
Clinical, Regulatory and Commercialization Strategies for Rare Diseases
Recorded on: May 22, 2012
Throughout the clinical development and commercialization lifecycle of products to treat rare diseases, there are a variety of clinical studies that can be conducted. Studies may be conducted for various reasons including product regulatory approval, patient access to a product for an unmet need, patient registries, or as a post-marketing requirement following product approval. The regulatory strategy employed often dictates the type of study that needs to be conducted to address an associated regulatory requirement. This webinar will address the various clinical, regulatory (US & EU) and commercialization strategies that may be implemented in the development of products to treat rare diseases and orphan indications.
In addition this webinar will describe regulations on the prescription of products prior to drug approval through compassionate use (EU) and expanded access programs (US). Compassionate use/expanded access programs allow sponsors to provide drugs to specific patients without other options. In many countries the programs also allow the collection of patient information to inform drug safety and effectiveness which can be used as part of the information used in the approval and reimbursement.
Register Free at www.appliedclinicaltrialsonline.com/rare