Outsourcing models that suit your situation
Collaboration Models
Salvius Legal provides a customized approach for clinical trial contracting, taking on the parts you do not wish to worry about, so that you can fully focus on other parts of your study.
Model I – “Extension” of legal team Sponsor
If CRO is contracted:
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- CRO has direct contact with sites
- CRO performs first review site changes & comments within agreed framework
- Site changes & comments outside framework are escalated to sponsor for approval
Salvius:
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- serves as an extension of Sponsor’s legal team (flexible resources)
- adds specific knowledge to assess and follow-up on escalations
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protecting Sponsor’s rights
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avoiding unnecessary delays and risk
Model II – Managing site contracts process
If CRO is contracted:
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- CRO has direct contact with sites
- CRO Operations communicates with Salvius
- CRO Contract Management is not involved (also not part of budget)
Salvius:
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- reviews and negotiates site changes & comments within agreed framework
- adds specific knowledge for review and negotiations
- keeps oversight of the process
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protecting Sponsor’s rights
-
avoiding unnecessary delays and risk
Model III – Managing site contracts process (no CRO)
If project is performed internally:
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- Operations has direct contact with sites
- Operations communicates with Salvius
- Salvius communicates with Legal on negotiation principles and legal framework
Salvius:
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- reviews and negotiates site changes & comments within agreed framework
- adds specific knowledge for review and negotiations
- keeps oversight of the process
-
protecting Sponsor’s rights
-
avoiding unnecessary delays and risk
Model IV – “Extension” of CRO Contract Management team
If CRO subcontracts Salvius:
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- CRO has direct contact with sites
- CRO Contract Management communicates with Salvius
Salvius:
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- reviews and negotiates site changes & comments within agreed framework
- adds specific knowledge for review and negotiations
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supports CRO in meeting its contract management objectives
Is the collaboration model you are looking for not represented above?
Or do you require any other customized or temporary contract management support?
Please contact us to discuss options