Master Service Agreement In Clinical Research

Posted by admin @ 9:02 pm on September 26, 2021

(a) Where CRO is required to enter into agreements with investigation sites or other third parties, including, but not limited to: data monitoring committees/data monitoring committees, clinical event committees/final decision committees, independent laboratories, advisory boards, carriers or delivery services or on the basis of the passport to provide third parties with services other than those provided by CRO, such as clinical supplies, packaging These third parties are independent contractors and are not considered collaborators, representatives or subcontractors of CRO or sponsor. Sponsor pays CRO for its reasonable time and costs for negotiating and managing such third-party agreements and for supporting compliance requirements requested by Sponsor. If these third parties claim compensation for loss or damage caused by the proponent`s project, the proponent must pay such compensation directly to the third party, but only under conditions acceptable to the proponent. Cro does not sign such indemnities on behalf of the Sponsor, unless the Sponsor has expressly authorized CRO to act for this purpose as a representative, or has given CRO a written mandate to sign such indemnities. The parties agree that all disputes, claims or controversies arising out of or related to this Agreement that are not resolved by their mutual agreement will be submitted in the first place to mediation with a mediator mutually chosen by the parties. (a) if cro is required to enter into contracts with auditors or review bodies (all “reviewers”), CRO will use its local form for clinical trials, subject to verification, modification and approval by the sponsor (“Local CTAs”) that have developed for use in certain countries based on local requirements. In countries where necessary, local CTAS shall be established in the national language or, where appropriate, in English, unless a sectoral form is required in the country concerned or a location-specific form is required by a selected website. CRO will make available to the Sponsor all applicable local CTAs, professional forms, specific location forms for inspection and approval by the Promoter prior to use, and CRO will promptly forward copies of all such executed documents to the Sponsor. Where an examiner insists on substantial changes to provisions that have a direct impact on the Proponent (confidentiality, intellectual property, liability, indemnification, publication, compliance with the minutes and inspection), CRO must submit the proposed amendment to the Proponent and the Proponent must verify, comment and/or approve the proposed amendments within ten (10) business days, if any. If the above forms or modifications approved by the Sponsor derogate from the terms of this Agreement (including, but not limited to, provisions allowing an examiner to publish results or data the disclosure of which is prohibited by cro), CRO assumes no responsibility for such provisions or modifications.

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