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Joel Hoffman, has more than 25 years experience in life sciences: academic (Harvard Medical School / Harvard School of Public Health), pharmaceutical industry (Pfizer), and consulting companies. In these positions he has developed systems and processes in support of medical and biopharmaceutical development including analysis and reporting, electronic submission, electronic data capture, clinical laboratory data warehouses, and operational reporting systems. Joel is Director of Life Sciences for Insightful Corporation where he works with a team to focus the knowledge of Insightful, its customers and partners, on value added applications, products, and solutions for life science companies
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Management Reporting of Clinical Trial Programs, Portfolios, and Studies: Managing Risks / Managing Projects
Joel Hoffman, Insightful
Managing a clinical trial is managing risk. In this presentation, the types of risk that companies and academic institutions face are reported from a study of 11 companies. Next, a best practice for managing risk in clinical trials will be described and discussed. The importance of metrics will also be described and best practices for establishing and using metrics in organizations. Finally, example uses of technology for managing risk in clinical trials will be shown.
The following topics in Clinical Development & Risk Management will be discussed:
1) Survey on Risk Dimensions in Clinical Development
- Background to the survey
- Dimensions of Risk Identified
Results, Safety, Efficacy, Recruitment, Timelines (other than recruitment), Budgets, Resources, Systems
- Summary
2) Processes for Managing Risk – A Best Practice
- Process Overview
- Basic Tools
- The Study Plan
* Project/Study Risks: Examples
* Study Status Review Meeting
* Tracking Tools
- Getting a Plan Pre-Approved
- Linking Team Members
- Summary: Managing a Trial is Managing Risks
3) Managing Risk with Metrics
- Approach to Developing Metrics
- Clinical Milestones and Deliverables
- Clinical Milestones and Metrics Used by Life Science and Academic Institutions
4) Example uses of Technology
5) Summary and Conclusions
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Management Reporting of Clinical Trial Programs, Portfolios, and Studies: Managing Risks / Managing Projects
Joel Hoffman, Insightful
Managing a clinical trial is managing risk. In this presentation, the types of risk that companies and academic institutions face are reported from a study of 11companies. Next, a best practice for managing risk in clinical trials will be described and discussed. The importance of metrics will also be described and best practices for establishing and using metrics in organizations. Finally, example uses of technology for managing risk in clinical trials will be shown.
The following topics in Clinical Development & Risk Management will be discussed:
1) Survey on Risk Dimensions in Clinical Development- Background to the survey- Dimensions of Risk IdentifiedResults, Safety, Efficacy, Recruitment, Timelines (other than recruitment), Budgets, Resources, Systems- Summary 2) Processes for Managing Risk – A Best Practice - Process Overview- Basic Tools- The Study Plan* Project/Study Risks: Examples* Study Status Review Meeting* Tracking Tools- Getting a Plan Pre-Approved- Linking Team Members- Summary: Managing a Trial is Managing Risks3) Managing Risk with Metrics - Approach to Developing Metrics- Clinical Milestones and Deliverables- Clinical Milestones and Metrics Used by Life Science and Academic Institutions 4) Example uses of Technology5) Summary and Conclusions
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Applying Roadmap Processes to the Clinical Trials Project Process
Joel Hoffman, Insightful Corporation
The Applying Roadmap Processes to the Clinical Trials Project Process workshop will be an interactive session. In the session we will:
* Highlight potential critical project failure points and explore approaches to remediate them or avoid them altogether through developing a project roadmap.
* Identify the potential market, technical and project information and resources to support development of the roadmap.
* Participants will benefit from the collective experience and wisdom of the participants, as well as work with proven tools and methodologies.
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