Outsourcing Strategy and Methodology: Making It a "Win-Win"


2 part webinar
60-minute presentation followed by 30-minute Q&A

 

Presenters:
Dr. Nimita Limaye, CCDM, is currently working as the vice president and global head (strategic data services & medical writing) at SIRO Clinpharm Pvt. Ltd., a leading Indian CRO, with a global presence across multiple geographies. She leads up all strategic engagements for clinical data management, biostatistics and programming and medical writing, and plays a key role in driving strategy, winning and establishing key engagements, ensuring sustainability and profitability, and driving operational excellence. She also serves as the vice chair of SCDM.

Ralph Russo, CCDM, is director of clinical data management and standards at Merck Research Laboratories. In this role, he has responsibility for EDC builds and external data management across all phases and therapy areas. Ralph has more than 23 years of experience in the pharmaceutical industry.

Part 1 – Step I: Outsourcing

  • Outsourcing Strategy – why outsource and to whom
  • VIPCO/FIPCO
  • Choosing a Business Model
  • Short-listing Vendor RFIs and Proposals

Part 2 – Step II: Sustaining the Relationship

  • Implementation Models (FTE or FSP)
  • Governance Models
  • Oversight Structure
  • Communication Processes and IEPs
  • Managing Expectations
  • When It Doesn’t Work
  • Risk Management

Continuing Education Credit Opportunity
Attendees are eligible for CEUs upon attendance and successful completion of assessment questions.  Each part of this 2 part webinar offers 0.2 CEUs.
SCDM is authorized by IACET to offer .2 CEUs for this program.

 

 

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