Clinical Research Organisation (CRO) master services agreement
Clinical Research Organisation (CRO) master services agreement

The following Life Sciences precedent provides comprehensive and up to date legal information covering:

  • Clinical Research Organisation (CRO) master services agreement
  • Background
  • 1 Definitions and interpretation
  • 2 Scope of work
  • 3 Legal requirements
  • 4 Remuneration
  • 5 Materials and inventions
  • 6 Confidentiality and publication
  • 7 Data protection
  • 8 Data ownership and management
  • More...

IP COMPLETION DAY: 11pm (GMT) on 31 December 2020 marks the end of the Brexit transition/implementation period entered into following the UK’s withdrawal from the EU. At this point in time (referred to in UK law as ‘IP completion day’), key transitional arrangements come to an end and significant changes begin to take effect across the UK’s legal regime. This document contains guidance on subjects impacted by these changes. Before continuing your research, see Practice Note: What does IP completion day mean for Life Sciences?

This Agreement is made on [date]

Parties

  1. 1

    [Insert the company name] a company registered in [England and Wales] under company number [insert registered number] and whose registered office at [insert address] (The Sponsor); and

  1. 2

    [Insert the company name] a company registered in [England and Wales] under company number [insert registered number] whose registered office is at [insert address] (The CRO)

(each of the Sponsor and the CRO being a party and together the Sponsor and the CRO are the parties).

Background

    1. (A)

      The Sponsor is sponsoring a series of clinical trials in support of marketing authorisation for the IMP and wishes to engage the CRO for certain services.

    1. (B)

      The CRO is knowledgeable and experienced in the design, management and conduct of clinical trials and wishes to provide such services to the Sponsor subject to the terms and conditions set out in

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