Maximizing 3rd Party Vendor RelationsFor

Medical Communications

CBI 7th Annual Forum on Dissemination of Scientific Information

May 25, 2010

Evan Demestihas, MD, RPh: Chief Executive OfficerThe Medical Affairs Company

Principal. Executive Management & Medical DirectorFounded Science Oriented Solutions (SOS) the industry’s

first Contract Medical Organization 1997-200825-year pharmaceutical industry veteran

Sandoz, BMS, Solvay

CMO CORE COMPETENCIES

Outsourced Field based Medical Teams

Medical Communications Services

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™

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

Medical Information Standard Operating Procedures

Customer Call Center Call Center OperationsAfter Hours Coverage

Emergency Procedures

Medical InformationMedical Information Operations

Adverse Drug Reporting Product Complaint Procedures

TrainingTraining & Development

SOPsSOP 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