Impact of Emerging “Big Data” Sources on Clinical Research and Review

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Impact of Emerging “Big Data” Sources on Clinical Research and Review

Identify the impact of emerging data sources in clinical research. Impact includes:

• How/where this data is typically collected and stored

• Typical data volumes and rate of data collection

• Use cases for the access, analysis, viewing, and review of these data types

• Mechanisms by which this data might be viewed or analyzed “in place” instead of physically moving or copying the entire data set

The overall goal of this effort is to promote awareness of the potential changes needed to cope with these emerging data sources.

Project Team Members

Interim industry lead: Louis Norton, Covance

Suresh Madhavan, PointCross (+individual to be assigned)

Hugo Geerts

Marcelina Hungria

**More members strongly encouraged**

Affected Stakeholder

Data providers (e.g. labs, hospitals, etc)

CRO(s)

Sponsor scientists & regulatory submissions groups

Reviewers / Regulatory agencies

System / Software vendors

Project Meeting Frequency

Every Two Weeks

Project Objectives and Timeline

Objective Timeline
Collect relevant data sources and use cases. Identify complementary or similar efforts for re-use of information already available. 3 months
Prioritize and do more detailed analysis on 3-4 relevant cases (ones for which information is available) – including consumption patterns (analysis, viewing). 5 months
Develop/document findings and recommendations for solution approach / architecture. Develop/document findings and recommendations for solution approach / architecture.

Other Initiatives that can be leveraged/merged

Recommended Solution(s)

Specific Actions

Deliverables and Dates:

Deliverable Date (ddMONyyyy)
Something Great 14MAR2013
Example Example
Example Example
Example Example



Last revision by Callard,03/26/2013