CLINICAL DEVELOPMENT

Moving into clinic means great progress, but also that stakes are getting higher.

 

Biolegal has experience of supporting sponsors all the way from preparation for selection of a CRO through close out and beyond.

 

Below are some specific areas and examples of matters where we may assist to further progress the project:

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• RFP documents for procurement of services (ascertaining that legal aspects are considered from the outset)

• preparation and participation in bid defense meetings

• drafting and contract negotiation of MSA with CRO and its subcontractors/vendors,

• work orders/scopes of work, including change orders

• data processing agreements,

• clinical trial agreements with study sites,

• agreements for investigator-initiated studies,

• coordinating investigator agreements,

• DSMB agreements,

• agreements with key opinion leaders, etc.

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