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...

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 this Agreement.

The parties agree

    1. 1

      Definitions and interpretation

      1. 1.1

        Definitions

        In this Agreement:

        Applicable Laws

        1. means:

          1. (a)

            any law, statute, regulation, by-law or subordinate legislation in force from time to time, and all subsequent amendments thereto, applicable to a party or the Study in any jurisdiction in which the parties operate or carry out the Study;

          2. (b)

            the common law and laws of equity as applicable to the parties from time to time;

          3. (c)

            any binding court order, judgment or decree;

          4. (d)

            any applicable industry code, policy or standard;

          5. (e)

            any applicable

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