Training & Support

Topics

Topics

14.0 Site and Sponsor Contracting

14.1 Agreement Management

Duration • 0 Minutes

Tutorial video to be made available shortly.

Agreements

Anova has master confidentiality agreements, master clinical trial agreements and fee schedules in place to enable the rapid activation and enrolment of a clinical trial.

Anova additionally has template material transfer agreements that can be used to support the rapid agreement between site and sponsor/manufacturer for a compassionate use program. In addition, Anova can provide sponsors and sites with access to a dedicated 21 CFR Part11 compliant eSignature system as part of their subscription.

Draft agreement(s)

Agreements between sites and sponsors/manufacturers can be administered out of the system and uploaded to the study/application record for access by all approved parties. Anova has master confidentiality agreements, master clinical trial agreements and fee schedules in place to enable the rapid activation and enrolment of a clinical trial.

Anova additionally has template material transfer agreements that can be used to support the rapid agreement between site and sponsor/manufacturer for a compassionate use program. In addition, Anova can provide sponsors and sites with access to a dedicated 21CFRPart11 compliant eSignature system as part of their subscription.

Upload agreement(s)

Agreements between sites and sponsors/manufacturers can be uploaded to the study/application record for access by all approved parties.

Negotiate agreement(s)

Agreements can be negotiated directly between applicants for a clinical trial or compassionate use program and the manufacturer/sponsor. Completed documentation can then be captured and shared as part of the study/application record. Anova has master clinical trial agreements and fee schedules in place to enable the rapid activation and enrolment of a clinical trial.

To talk to the Anova team about how we can support rapid activation of a study in as little as 5 days for a clinical trial and 24 hours for a compassionate use case, contact info.us@anovaevidence.com

Finalize and route agreement(s) for signature

Execution of agreements for clinical trials or compassionate use applications can administered between the site and sponsor/manufacturer administrator detailed in the application and then uploaded to the system for storage and retrieval by approved parties.

Note: Anova can provide sponsors with access to a dedicated 21CFRPart11 compliant eSignature system as part of their subscription. 

For more details contact info.us@anovaevidence.com

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