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May 30, 2012

Advanced EDC Trials: The Unique Needs of Biotech/Biopharma

Speakers for this Event:
  • St. Clare Chung, Director - Biostatistics & CDM, SCiAN Services Inc.  Learn More
  • Ann Neale, VP Clinical Operations, Biotie Therapies, Inc.  Learn More
  • Advanced EDC Trials: The Unique Needs of Biotech/Biopharma

    At the core of conducting a successful clinical trial is how you collect and manage your data. The primary need of Biotech/Biopharma companies is consistent and scientifically/medically credible data delivered on time and on budget, one study at a time; under the constant challenge of significant "mid-study" protocol and database changes.

    In this 1st of 4 webinars, Ann Neale and St. Clare Chung will start the discussion by providing insight into the unique needs of Biotech/Biopharma companies from both the Sponsor and Technology/Services providers (CROs) perspectives. Subsequent webinars will focus on case studies, specific challenges and solutions.

    Topics covered include:

    • A typical sponsor's team and resources
    • Clinical trial considerations (phase IB - late phase IIB / III)
    • Sponsor's business needs
    • Understanding how CROs and EDC providers work
    • Modules, functionality and tools needed beyond a basic EDC system
    • Establishing streamlined data quality expectations up-front across all functional teams; Identifying warning factors and signals

    What you will learn:

    • Identify factors that should inform your decision, and what shouldn’t
    • What to look for when choosing your data management partner
    • Considerations for selecting the right EDC system for you
    • Establishing data quality expectations up-front: understanding the cost-benefit concerns
    • Creating teams that get results
    • Bridging the communication gap between clinical and technical groups

    This webinar is Part 1 of a series on Advanced EDC Trials:

    Part 1 -  Archive available - see bottom of webpage for more information
    May 30, 2012
    The Unique Needs of Biotech/Biopharma
    Part 2
    June 8, 2012
    Bringing the Team Together
    Part 3
    Sept 10, 2012
    The Team is Working Together, Now Get Ready for Change
    Part 4
    Nov 9, 2012
    The Homestretch - Don't Let the Timelines Slip

    Clinical Operations, Clinical Development, R&D, Clinical Trials Project Managers, Lead CRAs


    St. Clare Chung, Director - Biostatistics & CDM, SCiAN Services Inc.

    St. Clare Chung is currently Director of Bio-statistics & CDM at SCiAN Services headquarters located in Toronto, Ontario. She has more than a 20 years of experience in statistical consulting, clinical data management, data analysis and clinical report writing.

    Ms. Chung is also one of the original developer's of SCiAN's paper and EDC data management systems and was involved in the concept, design and implementation o f the systems. Her research interests are in Bayesian designs for Phase I/II studies and survival analysis.

    Ann Neale, VP Clinical Operations, Biotie Therapies, Inc.

    Ann Neale is the VP Clinical Operations at Biotie Therapies, Inc. Ms. Neale has over 20 years experience in all phases of clinical development and has managed global clinical programs for biologics and small molecules.

    Prior to joining Biotie in 2007, Ms. Neale was VP Clinical at Saegis Pharmaceuticals, Inc. responsible for clinical development of the company's central nervous system (CNS) compounds which were acquired by the Danish neuropharmaceutical company Lundbeck. Other positions have included Sr. Director Development Planning and Operations at Aryx Therapeutics and 10 years as a clinical development consultant. Prior to consulting, Ms. Neale held various positions of increasing responsibility in clinical development at Titan Pharmaceuticals, Applied Immune Sciences (acquired by Rhone- Poulenc Rorer) and Syntex (acquired by Roche).

    Ms. Neale received her B.S degree in Nursing from the University of Minnesota in 1985.


    SCiAN - a science-technology based contract clinical research company (CRO) - provides e-clinical and EDC solutions and clinical data management systems and services to the healthcare industry for IND stage (phases II - III) clinical trials.

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

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