1、A Modern Guide to Clinical Operations Resourcing|1TheFDAGA Modern Guide to Clinical Operations Resourcing How to Balance Outsourcing and Insourcing Models for Maximum Flexibility,Productivity,and EfficiencyTheFDAG Table of Contents4 Summary7 Introduction and Background9 Challenges and Opportunities

2、in Clinical Operations Resourcing13 Determining the Optimal Resourcing Model or Mix18 Creating a Simple Decision Matrix for Clinical Operations Resourcing20 A Few Key Questions to Consider25 Finding the Right Insourcing Resourcing Partner28 Next StepsA Modern Guide to Clinical Operations Resourcing|

3、2TheFDAGMeet the ContributorMark Shapiro,MA,MBA.Mark Shapiro brings two decades of management consulting and hands-on operational leadership experience for clients in the pharmaceutical,CRO,and biotech business.His expertise is growth strategies,business transformation,and operational excellence wit

4、hin clinical research and clinical development.Specialties:Systems-based solutions to develop and integrate people,processes,and information technology to support clinical research and clinical development.Business analytics and performance optimization.Therapeutic Areas of Expertise:Solid and Hemat

5、ologic Tumor Oncology,Nephrology,Infectious Diseases and Vaccines,Critical Care Medicine,Psychiatry,and Pediatrics.A Modern Guide to Clinical Operations Resourcing|3TheFDAGSummaryFacing an intensely competitive talent market,and growing pressures around productivity and cost,clinical teams are recon

6、figuring their R&D operations and organizational structures to get more done in less time with better outcomes.While full-service outsourcing isnt going anywhere,especially as startups and small players continue to enter the market,companies experiencing rapid growth and those with more extensive R&