GCDMP - Vendor Selection Flashcards
How does a Transactional Business Model work in CDM?
The sponsor contracts vendors on a per study or per trial basis.
How does a Strategic Partnership Business Model work in CDM?
Companies with complementary skills for a partnership to increase efficiencies and lower costs.
Who is it that an organization outsources work to perform select activities on a trial?
Functional Service Provider
Who leases software to clients for use on trials?
Application Service Provider
What should an organization do before beginning to qualify vendors?
Decide what services require assistance from a vendor and define which attributes will be most important in the selection of vendors.
What are the three most important attributes of vendor evaluation?
- Sufficient staff
- Adequate standards requirements
- Staff is adequately qualified and trained
What should a Request For Information (RFI) include when sent to a vendor?
- Company historical informations
- Products and services
- Experience and areas of expertise
- Product demonstration
- Computerized systems
- Results of previous regulatory inspections, as permitted
Who should review a Request For Information (RFI) to evaluate a vendor?
A Subject Matter Expert (SME)
Do identified deficiencies from the Request For Information (RFI) result in the vendor being eliminated?
No.
What two items are required to be completed before a vendor relationship is official?
Contract and statement of scope of work
In transactional outsourcing, are costs always the same?
No, a detailed cost list and scope of work should be drawn up at the beginning of the partnership and should include provisions for changes in costs.
What 4 ownership responsibilities should be outlined in the Task Ownership Matrix.
Who is responsible/accountable/consulted/informed for the task/document. Can also be called RACI matrix.
What function does a roles and responsibilities matrix (bid grid) serve?
Captures Sponsor’s pre-defined study specific cost drivers and allows outsourced partners to assign prices to tasks associated with the cost drivers.
What should vendor milestones be based on?
Defined deliverables through the course of the study.
Every clinical study should include governance documents that explicitly describe how various processes will be carried out such as:
Training and onboarding plans, transition plans to cover staff changes, key milestones, performance metrics, communication plan, escalation plan
