Maximizing 3rd Party Vendor Relations
For
Medical Communications
CBI 7th Annual Forum on Dissemination of Scientific Information
May 25, 2010
Evan Demestihas, MD, RPh: Chief Executive Officer
The Medical Affairs Company
Principal. Executive Management & Medical Director
Founded Science Oriented Solutions (SOS) the industry’s
first Contract Medical Organization 1997-2008
25-year pharmaceutical industry veteran
Sandoz, BMS, Solvay
CMO CORE COMPETENCIES
Outsourced Field based Medical Teams
Customized Programs:
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MSLs
Clinical Specialists
CTLs
MCLs/MMLs
FORMs
Program Management & Support:
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Strategic Planning
Capacity Analysis
Territory Alignment/Mapping
Management Structure
SOPs/Processes
Metrics/Analytics
Stakeholder Mix/Customer Focus
Recruitment:
• Profile/Role Development
• Sourcing
• TMAC/Client Interviews
Medical Communications Services
Call Center:
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Fully staffed by HCPs
Drug Information
Adverse Event Handling
Product Complaint Handling
8 or 12-hour support
Medical Writing:
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Standard Response Letters
FAQs
SOPs
Abstracts/Poster Presentations
Literature Surveillance:
• Proactive & Reactive
• Literature Retrieval & Analysis
• Copyright Clearance Management
Knowledge Management:
Training & Development:
• IRMS capability
• Searchable databank
• Customized Metrics/Reporting Tools
• Core Competency
• Compliance Programs
• Administrative
Medical Meeting Support:
• Booth Support
IT/Operations/HR/Finance
i-MSL™
• Competitive Intelligence Analysis
• Symposia/Poster Reviews
GOAL
Optimize the relationship with the outsourced
vendor to meet effective medical communications
through compliant strategies
Outsourcing:
Delivering Value Through Efficiencies
 Capitalizes on heavy-lifting and expedient program
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implementation while limiting burden to organization
Provides greater versatility & enhanced flexibility addressing
internal challenges
Optimizes headcount limitations
Mitigates financial risk
Utilizes internal resources more effectively
Expands infrastructure & resources
Engages strategic insight and focused expertise
 New company with no medical
communications department presence
 Established company with fully
functional medical communications
department
Assessment Steps / Needs Analysis
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Current department assessment
Expected workload impact
Expected available resources
Outsourcing considerations
Company A
 New Company
 Medical Communications & MSL outsourced
 Limited home office personnel
Company B
 New Company
 Launch only support to handle increased volume
 Only consumer calls triage to vendor
Company C
 Established Company – big pharma device
division
 Internal headcount constraints
 Overflow only support directed by client
Company D
 Generics Company
 Rapidly expanding portfolio
 Adverse Event only capture & processing
 Decided not to build internal expertise in this
area
Vendor Assessment & Selection
 Finding the right vendors
 Screening call
 RFP process: standardize criteria
Typical RFP
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Project specifications
Company background & experience summary
List relevant companies supported
Number of new clients added in the last year including volume/services provided
Experience and education of the professional & non-professional staff
Are they FT or freelancers / consultants
Overview of the operation
New program set-up; SOPs; staffing methodology
Describe management and QA process
Service level reports
Technology; validated?
Representative work samples (reports, SOPs)
Timeline
Detailed budge
References
Vendor Assessment & Selection
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Finding the right vendors
Screening call
RFP process: standardize criteria
Vendor presentations
Reference check
Site visits
Vendor Training
 Technical training
 Corporate policies and procedures
Medical Information Standard
Operating Procedures
Customer Call Center
Call Center Operations
After Hours Coverage
Emergency Procedures
Medical Information
Medical Information Operations
Adverse Drug Reporting
Product Complaint Procedures
Training
Training & Development
SOPs
SOP Revisions
SOP Deviations and Change Requests
Vendor Training
 Technical training
 Corporate policies and procedures
 Ongoing
Vendor Monitoring
 Communication channels
 Site visits
 Audits
Hallmarks of a Good Vendor
 Reachable
 Understanding
 Responsive
 Flexible
 Quality
 Value