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Client:
- Insufficient internal clinical operational resources to support a specific therapeutic trial
- Required a high level of therapeutic expertise of the resourced team
- Trial timeline restrictions due the seasonality of the product and prearranged training schedules
- Focus on Project Management responsibilities
DOCS:
- Assembled a team of, 3 Lead CRAs & 9 regional CRAs with specific therapeutic experience
- Exceeded required timelines for staffing the project and providing appropriate proficiency and qualifications
- Lead CRA performed the administrative tasks associated with the resourced team
- Enhanced relationship with Investigator sites due to project teams therapeutic expertise
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Client:
- Develop an in-sourcing model to hire and transfer contracted employees
- Grow and develop contracted employee talent pool
- Maintain employee numbers, although not able to hire on a permanent contract
- Needed a tailor-made coaching and training program for their contract employees
DOCS:
- Seamlessly transferred existing client’s employees
- Created a training and coaching program for contracted employees
- Provided a Clinical Team Manager, to coach and train contracted employees
- Reduced costs my decreasing number of employee terminations
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Client:
- Alternative solution for a program of Phase II studies while maintaining study management control
- Sought a flexible model for use of study resources
- Needed a cost effective solution
- Wished for CRAs to function as an extension of their team
DOCS:
- Provided a Clinical Team Manager who worked in sponsor office
- Deployed a team of 14 CRAs within close proximity to their assigned sites
- Utilised our clients CTMS and EDC systems
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Client:
- Strategic move to an FSP model for global site management activities (CRAs & CTAs)
- Eliminate fixed cost base via risk sharing
- Increase productivity via contractually mandated standards
- Reduce R&D spend while enhancing quality
DOCS:
- Deployed global site management teams within 60 days
- Increased monitoring productivity by 60% within 6 months
- Reduced cycle times for site initiation and study execution
- Reduced net sponsor spend >35%
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