Speakers for this Event: St. Clare Chung, Director - Biostatistics & CDM, SCiAN Services Inc. Ann Neale, VP Clinical Operations, Biotie Therapies, Inc.

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

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