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Contract Research and Manufacturing Services (CRAMS) in India by G Gokhale, M Antani

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6

Service agreements

Abstract:

Once the outsourcing company has selected the CMO/ CRO, it is extremely critical to enter into a detailed agreement. The outsourcing contract forms the core of a successful outsourcing relationship and must capture the unique business strategies and concerns and the commercial understanding of the parties. As regards liability arising out of the trial, relevant clauses must be inserted for allocation of responsibilities among the parties and are a requirement for obtaining insurance. Apart from clauses on indemnification, clauses related to the obligations of all parties involved, use of investigational drugs, supply chain, change of control, intellectual property, confidentiality, roles and responsibilities must ...

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