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Experience

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

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

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

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%