Maximizing 3 rd Party Vendor Relations For Medical Communications CBI 7 th 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:

MSLs Clinical Specialists CTLs MCLs/MMLs FORMs • • • • • • •

Program Management & Support :

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 • • •

Training & Development:

Core Competency Compliance Programs Administrative

IT/Operations/HR/Finance i-MSL™ Medical Communications Services

• • • • •

Call Center:

Fully staffed by HCPs Drug Information Adverse Event Handling Product Complaint Handling 8 or 12-hour support • • • •

Medical Writing:

Standard Response Letters FAQs SOPs Abstracts/Poster Presentations • • •

Literature Surveillance :

Proactive & Reactive Literature Retrieval & Analysis Copyright Clearance Management • • •

Knowledge Management :

IRMS capability Searchable databank Customized Metrics/Reporting Tools • • •

Medical Meeting Support :

Booth Support 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 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

    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

               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

      Finding the right vendors Screening call RFP process: standardize criteria Vendor presentations Reference check Site visits

Vendor Training

  Technical training Corporate policies and 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