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:

  • 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.