An outsourcing strategy doesn't have to be huge. It needs to identify and meet the key needs of the sponsor's clinical development goals. Program, pipeline or single study, there essential elements that OM360 can ensure are not overlooked. The earlier the better. Do you have a plan?
Examples of a custom-built Outsourcing Strategy components include...
Outsourcing Categories
High level grouping of provider targets. These can range from Early Phase, IIb/III Phase, Speciality, Technology, Central Lab, Bioanalytical Lab. Failure to fully consider the range of providers required can leave gaps in study execution and completion.
High level grouping of provider targets. These can range from Early Phase, IIb/III Phase, Speciality, Technology, Central Lab, Bioanalytical Lab. Failure to fully consider the range of providers required can leave gaps in study execution and completion.
Financial Goals
Keeping it real. Binding forecast development costs with internal budgetary & delivery schedules to ensure the program or project is viable, balancing time vs. cost. What sort of CRO is likely to best support financial constraints and limitations. Do penalty/bonus clauses work?
Keeping it real. Binding forecast development costs with internal budgetary & delivery schedules to ensure the program or project is viable, balancing time vs. cost. What sort of CRO is likely to best support financial constraints and limitations. Do penalty/bonus clauses work?
Define Internal Capabilities & Limitations
A gap analysis to identify full or partial support needed from Third Parties, standards, and practices that need to be integrated with the provider. Should BioStatistical work be kept in-house? Where are the boundaries between sponsor and provider expertise - how can the CRO know-how be fully utilised as an intelligent partner?
A gap analysis to identify full or partial support needed from Third Parties, standards, and practices that need to be integrated with the provider. Should BioStatistical work be kept in-house? Where are the boundaries between sponsor and provider expertise - how can the CRO know-how be fully utilised as an intelligent partner?
Project Scale and Relationship
The level of spend can determine leverage and interaction with the CRO. Identifying whether a smaller scale local provider and subcontracted providers is more feasible than large-scale global provider. What is the reality of the pipeline vs CRO expectations. Starting on a false premise can ruin future provider responsiveness.
The level of spend can determine leverage and interaction with the CRO. Identifying whether a smaller scale local provider and subcontracted providers is more feasible than large-scale global provider. What is the reality of the pipeline vs CRO expectations. Starting on a false premise can ruin future provider responsiveness.
Risk Management
Build-in contingencies - how can budget be invested where it will insure against project failure? What are the critical success factors that providers need to meet that will get the project through to a meaningful CSR. Where are the biggest risks that need mitigating - regulatory or CMC?
Build-in contingencies - how can budget be invested where it will insure against project failure? What are the critical success factors that providers need to meet that will get the project through to a meaningful CSR. Where are the biggest risks that need mitigating - regulatory or CMC?
..... and all the other elements that turn the strategy into an actionable plan.
