Targeted Analytics: Using Core Measures to Jump-Start Enterprise Analytics
Selecting Core Clinical It Solutions For Life Sciences Organizations – Key Strategies
1. Technology Solutions
for Life Sciences & Healthcare
“Selecting Core Clinical IT solutions for Life
Sciences Organizations – Key Strategies”
Oracle's 4th Annual Clinical Development and Safety Conference 2010
6th & 7th Oct, 2010
Mr. Subbaraju Sagi
Mr. Vinoth Kumar T
2. Agenda
Market challenges & drivers for Life Sciences Organizations
Addressing key challenges for Clinical & Safety Data
Management with IT
IT challenges for CRO’s and Pharmaceutical companies
Considerations in selecting Clinical & Safety IT solutions
Strategies for Clinical & Safety IT implementation in Life Sciences
companies
Summary
3. Market challenges & drivers for Life Sciences Organizations
3
Complex Lifecycle of Drug Development Lower cost and reduce time from
lab to market to gain competitive
High level of financial risk
advantage
Problems in patient recruitment
Targeted investigator and patient
Evolving industry standards - Failure to recruitment and managing
compliance investigator relationships
Perform submission of clinical and
Delay in clinical data review and
safety data with the highest quality
submission to FDA
in the prescribed industry standard
Delay in safety data reporting format
Inefficiency in tracking trial metrics Develop highly skilled personnel for
future drug development
Hesitation in adopting new technologies
Lack of proper training facility – In-house
and at Clinical Sites
4. Addressing key challenges with IT Solutions
4
Decrease in clinical data
Cost reduction through review and submission
process re-engineering time with the use of
industry standard data
Increase in speed models
through automation
Use of Clinical
IT Solutions
Improved data quality Trial metrics tracking can
and security with be done with the use of
electronic signatures and Business Intelligence
validation tools
5. Clinical Development Landscape Today
Silos of Activity, Inefficient Process Flow & Little Re-use of Information
Trial Design Investigator Recruitment/ Data
Assistance Clinical Data Management Collecti
Drug Supply Management on
Patient Recruitment/ Reporting
Tracking & Enrollment Tools
Management Data
Listings Document
And Image Regulatory
Statistical Management Affairs
EDC Programming
Lab Data Faster
Document Publishing/
Lab Data
Electronic Submission
Decisions
Statistical/ Management
Clinical Reports Medical Term Trial Data
Coding Capture Patient Education/
Remote Monitoring
Protocol Implementation,
Investigator Clinical DB Clinical Trial
Monitoring Creation/Mapping, Queries Management System
Patient
Statistical
Diaries Portfolio
Site Initiation/ Analysis
Management/
Assessment
Reporting
Adaptive Trials
6. IT challenges for CRO’s and Pharmaceutical companies
6
Understanding of IT for performing vendor selection
Analyzing IT infrastructure for Enterprise Ecosystems in alignment
with the business model
Qualify all clinical IT systems according to the regulatory standards
Investment in hardware and purchase of software licenses according
to the operational efficiency
Dependency on the vendors for application support and
maintenance
7. Considerations in selecting clinical IT Solutions
7
1. Perform Vendor Selection and
evaluation
2. Check for Compliance to industry
standards and regulatory requirements
3. Analyze costs involved in deployment
and maintenance
5. Check for External application 4. Availability of application to end-
integration capabilities users, User friendliness
6. Check for availability of
application upgrade and support
8. Strategies for IT implementation in Life Sciences companies
8
Selection of application service – Vendor hosted, Licensed product,
outsourced or partially outsourced
Generate a roadmap to IT solution implementation by analyzing
enterprise architecture
Use work modeling techniques to understand existing workflow and
practices
Conduct Interviews, surveys, focus groups, field observations with
IT staff and subject experts with prior clinical background/expertise
who are suitable to carry out these tasks
9. Strategies for IT implementation in Life Sciences companies
9
Use pilot studies to better understand what work changes the
system is likely to trigger
Analyze security loop holes for data security
Perform a complete Risk Mitigation plan
Develop a regular internal audit for checking technical issues
Keep all communication channels open and have a problem
resolution work flow
10. Summary
10
Challenges in Clinical & Safety data management