Webinars

2008 Program

• Forthcoming Events

• December

  Next Generation Integration

  Speaker(s):

  • Dr Gunter Bellaire
    Director of Operations at Perceptive Informatics
  • Solomon Shacter
    Director, Product Management - Platform Solutions

  Time:

  • Tuesday, 9th Dec
    3:00 pm UK time - 10:00 am US East Coast time
  • Thursday, 11th Dec
    6:00 pm UK time - 1:00 pm US East Coast time
  • Please contact me to arrange a date & time

  • Clear the selected dates to start over.

  Agenda:

  The integration of disparate systems has introduced many benefits to clinical trials.

  The integration of disparate systems has introduced many benefits to clinical trials. Key benefits include immediate access to decision-enabling data, sharing of critical information with multiple stakeholders, the elimination of redundant data entry and negating the need for discrepancy resolution between databases. At the same time, point-to-point integrations have introduced new issues to study teams that a Clinical Technology Integration Platform (CTIP), or clinical middleware solution, can overcome. 

  This webinar will examine the benefits of middleware in the clinical environment.  The session will also present a case study where Imaging, IVRS, EDC and CTMS were successfully integrated.  The case study will illustrate how multiple systems can be joined to yield greater value than isolated systems.

  Attend this webinar to:

  • Identify best practices and trends in making integrations repeatable and sustainable
  • Overcome integration challenges that impact technology and people
  • View a first-hand case study that illustrates how to bring together multiple eClinical Systems

  Webinar Speakers include:

  Solomon Shacter, Director, Product Management – Platform Solutions at Perceptive Informatics (formerly ClinPhone)  In his role as Director, Product Management – Platform Solutions, Solomon guides the product design, development and marketing of the Connect Technology Interchange Platform ensuring that it grows, maintains a competitive edge and continues to meet the evolving needs of customers.

  Gunter Bellaire, Director of Operations at Perceptive Informatics  Gunter Bellaire received a PhD, in Image Processing in 1995.  Before taking his post as Director of Operations, Dr. Bellaire led the EU Perceptive Operations for Medical Imaging, Interactive Voice Response Systems and Web solutions within Perceptive.

  Introduction and Closing Remarks:

  Bill Byrom, VP of Product Strategy and Marketing at Perceptive Informatics (formerly ClinPhone)  Bill joined Perceptive Informatics (formerly ClinPhone) in July 2000 where he is the V.P. of Product Strategy and Marketing. He holds responsibility for providing strategic direction to Perceptive’s suite of products including developing new areas of technology application within clinical trials and healthcare.

  
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• Past Events

• April

  Overcoming Challenges in Scaling Up EDC

  Speaker(s):

  • Kyle Flickinger
    VP, Professional Services
  • Paula McHale
    Director of Product Management

   

  • You may need to register to watch it beforehand

  Agenda:

  The adoption of EDC has greatly accelerated in the past year and many companies have moved beyond pilot mode.

  The adoption of EDC has greatly accelerated in the past year and many companies have moved beyond pilot mode.  Yet, few companies are implementing EDC on all of their trials and the majority of trials are still paper based.  Also, scaling up the use of technology brings new challenges such as providing adequate training for all users, dealing with paper and electronic forms and integrating multiple streams of data for each study. As sponsors and CROs continue to move into the eClinical age, what are the key factors they need to consider? How can they overcome the challenges of scaling up EDC?
  
  Paula McHale, Product Director for Data Management Solutions at ClinPhone and Kyle Flickinger, Vice President of EDC Professional Services at ClinPhone will discuss the issues and solutions in taking EDC from pilot mode to full scale use in global clinical trials in this hour-long educational webinar.
  
  Topics to be discussed include:

  • Dealing with the hybrid world of paper and electronic trials
  • Helping sites move from paper to web-based EDC
  • Implementing one unified clinical data management platform to handle paper and electronic studies
  • Develop successful data integration with other clinical technologies such as IVR/IWR and CTMS
  • Streamline and unify electronic patient-reported outcomes (ePRO) data and EDC
  • Minimize the impact of “re-engineering” the clinical process

  
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• May

  ePRO Models for Use and Validation of ePRO Modalities

  Speaker(s):

  • Diane Wild, Oxford Outcomes
    Founder and Director
  • Keith Wenzel
    ePRO Product Director

  Agenda:

  The biopharmaceutical industry is looking at electronic collection of patient reported outcomes (ePRO) with renewed focus.

  The biopharmaceutical industry is looking at electronic collection of patient reported outcomes (ePRO) with renewed focus.  There now exist many published examples of how ePRO can be used by clinical trial sponsors to make their trials more efficient and/or to increase the integrity and precision of the data they are collecting.

   

   

  However, when paper-based PRO instruments are converted or migrated to electronic administration, the sponsor must take steps to ensure that the PRO instrument still collects the information for which it was designed. Sponsors need to assess the magnitude of the change and select the appropriate validation methodology for the electronic instrument.

   

   

   

  This webinar will review the models for use for ePRO including primary and secondary efficacy data; facilitating adaptive trial designs and subject eligibility screening; and monitoring and alerting sites of a subject's changed health status.  In addition, this webinar will detail the different types of validation that sponsors may wish to conduct and will review validation designs from published and unpublished validation research.

   

   

   

  Webinar attendees will receive an update with respect to the industry's current thinking for ePRO validation methods and examples of published models for use for ePRO.

  
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• September

  Basic & Advanced Randomization Methodologies

  Speaker(s):

  • Damian McEntegart
    VP of Statistics and Product Support
  • Malcolm Morrissey
    Statistician, Special Projects and Statistical Sup

   

  • You may need to register to watch it beforehand

  Agenda:

  In today’s clinical trials, there is a noticeable increase in the adoption of clinical technologies to electronically capture data and perform randomization and automated supply chain management.

  In today’s clinical trials, there is a noticeable increase in the adoption of clinical technologies to electronically capture data and perform randomization and automated supply chain management. These common processes are frequently performed via Interactive Voice Response (IVR), Interactive Web Response (IWR) and Electronic Data Capture (EDC) systems.

   

  This tutorial discusses how randomization solutions can be effectively implemented using the methodologies listed above.  It is designed to provide study teams with a firm foundation for evaluating the value of these solutions in a specific study, and for contributing effectively to defining the requirements of a study system. No specialist knowledge is required to benefit from the tutorials. Two highly experienced industry statisticians describe the use of IVR systems in central randomization.
  
  Key topics include:

  • Benefits of IVR/IWR randomization approach
  • Methodologies available:
  • blocked randomization (central, stratified)
  • covariate adaptive randomization (minimization, dynamic hierarchical balancing, Zelen’s)
  • Selecting the optimal randomization method
  • Randomization considerations for Open Label Studies
  • Benefits of IVR/IWR systems for Adaptive Trial Designs
  • Forced randomization – definition, and survey of existing practice
  • Randomization schemes that conserve trial supplies
  • EU and FDA regulatory considerations– definition and regulatory acceptability

  
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• September

  Automated Trial Supply Management

  Speaker(s):

  • Todd Kole
    VP of Global Client Services

   

  • You may need to register to watch it beforehand

  Agenda:

  In today’s clinical trials, there is a noticeable increase in the adoption of clinical technologies to electronically capture data and perform randomization and automated supply chain management.

  In today’s clinical trials, there is a noticeable increase in the adoption of clinical technologies to electronically capture data and perform randomization and automated supply chain management. These common processes are frequently performed via Interactive Voice Response (IVR), Interactive Web Response (IWR) and Electronic Data Capture (EDC) systems.

   

  This tutorial discusses how IVR, IWR and EDC technologies can be implemented and used effectively. It is designed to provide study teams with a firm foundation for evaluating the value of these solutions in a specific study, and for contributing effectively to defining the requirements of a study system. Further, integrating these systems to reach new levels of efficiencies will be discussed. No specialist knowledge is required to benefit from the tutorials.

   

   Key topics include:

   

  • How IVR/IWR systems automate the dispensing and trial supply chain
  • Basic methodologies available:

  -                     trigger/re-supply

  -                     predictive algorithm

  -                     just-in-time delivery

  • Special considerations for managing dose titration studies
  • Preventing treatment unblinding or partial unblinding
  • Use of simulation for estimating supply requirements
  • Impact on supplies of Adaptive Trial Designs

  
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• September

  From Paper to Web - Implementing a Fully Integrated EDC Solution

  Speaker(s):

  • Paula McHale
    Director of Product Management

   

  • You may need to register to watch it beforehand

  Agenda:

  In today’s clinical trials, there is a noticeable increase in the adoption of clinical technologies to electronically capture data and perform randomization and automated supply chain management.

  In today’s clinical trials, there is a noticeable increase in the adoption of clinical technologies to electronically capture data and perform randomization and automated supply chain management. These common processes are frequently performed via Interactive Voice Response (IVR), Interactive Web Response (IWR) and Electronic Data Capture (EDC) systems.

   

  While the numbers of EDC studies are constantly on the rise, there are still a large number of studies that are using paper forms in one way or another.  Reasons for this include remote site locations, site preference, or the need to incorporate extraneous patient data from paper sources, such as patient-reported outcomes.  Additionally, some sponsors are still using paper as they continue to reengineer processes to accommodate EDC.  Implementing an EDC system that includes the ability to perform double data entry allows the flexibility to have some sites record their data within the EDC system and others to collect their data on paper and ensures that extraneous paper forms can be easily added to the clinical database. 

   

  Paper forms and CRFs are one key example of the many data streams that must become part of the final clinical database at the end of the study.  Other sources include randomization data, ePRO data, laboratory results, ECGs and coded adverse event and drug terms to name just a few.  A fully integrated EDC solution must consider all such sources.  With planning and careful system design, technology can improve and expedite the process of merging study data and can ultimately speed up the data locking process.  Through integration, data can be brought in and out of your EDC system to maximize the efficiency of your sites and study team.

   

  This webinar will discuss how to review the electronic systems that are being used for your study and determine which data to integrate so you can bring the most value to your study. 

   

  Topics to be discussed include:

  ·         Dealing with the hybrid world of paper and electronic trials

  ·         Helping sites transition from paper to web-based studies

  ·         Implementing one unified clinical data management platform to handle paper and electronic studies

  ·         Developing successful data integration with other technologies such as IVR, ePRO and CTMS

  ·         Planning for integration – what steps need to be taken to ensure a smooth go-live

  ·         Considerations for selecting a vendor to integrate your systems – what questions should you ask?        

  
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• October

  Optimizing Adaptive Trial Designs- Using Simulation Methodologies to Overcome Challenges

  Speaker(s):

  • Dr. Nitin Patel
    Co-Founder, Chairman & CTO of Cytel, Inc.
  • Graham Nicholls
    Product Manager

  Agenda:

  Optimizing Adaptive Clinical Trial Designs – Using Simulation Methodologies to Overcome ChallengesAdaptive trial designs are now widely utilized within clinical development programs as a means of increasing the probability of finding the truly optimal dose, thereby improving the likelihood of a successful study outcome.

  Optimizing Adaptive Clinical Trial Designs – Using Simulation Methodologies to Overcome Challenges

  Adaptive trial designs are now widely utilized within clinical development programs as a means of increasing the probability of finding the truly optimal dose, thereby improving the likelihood of a successful study outcome. Adaptive trials can also accelerate the time required for overall drug development by implementing a seamless transition from Phase II to Phase III, resulting in drugs getting to the market faster.

  As defined by the PhRMA Working Group on Adaptive Trial Designs, an adaptive trial design is "a multistage study design that uses accumulating data to decide how to modify aspects of the study without undermining the validity and integrity of the trial".

  Adaptive trial designs often require additional up-front investigation of the statistical properties of various study designs being considered. In response, recent advancements in sophisticated simulation modelling tools enable the comparison of design options to ensure that the selected design meets the required statistical rigor.

  Another key consideration when planning an adaptive trial design approach is the impact on supplies of the design adaptations that may occur during the enrolment period. Simulation is valuable in exploring the quantity of medication required, the impact of mid-study changes, and the effect of different packaging configurations on the total quantity of medication required.

  This webinar will explore (via case study) the use of simulation tools in determining the most appropriate study design and planning supplies in adaptive clinical trials. We are pleased to welcome Dr. Nitin Patel, co-founder, chairman and CTO of Cytel Inc. as a guest speaker in this hour-long educational webinar. Dr. Patel will be joining Graham Nicholls, Product Manager at ClinPhone (now part of the Perceptive Informatics family). Topics that will be covered include:

  • Brief summary of adaptive trial designs and concepts.
  • Role of modelling tools to investigate study design properties.
  • Trial supply management considerations and options for reducing supply overage.
  • Evaluating supply requirements (both pre- and mid-study) via simulation.

  
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• October

  Cardiac Safety in Clinical Trials

  Agenda:

  Join us for a 30-minute webcast that will address the increasing need for the appropriate assessment of cardiac safety in clinical trials, both during product development, post-approval and marketing.

  Join us for a 30-minute webcast that will address the increasing need for the appropriate assessment of cardiac safety in clinical trials, both during product development, post-approval and marketing.

  The Role of Clinical Data and Measuring Cardiac Outcomes
  Thomas Shook, M.D.
  Senior Medical Director
  PAREXEL International

  The Role of Cardiac Imaging
  Peter Gardiner, MB ChB, MRCP
  Scientific Advisor
  Perceptive Informatics

  Click here for more information and to register:
  http://www.perceptive.com/news/events.html

  
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