Sponsor and vendor (CROs, FSPs, etc.) collaboration is increasing as a way to get medicines submitted to agencies and in front of patients faster. There are a number of ways for Sponsors and CROs to collaborate in P21 Enterprise.
🤝 Ways to Collaborate
There are two main methods of collaboration inside P21E:
Environment Share = A sponsor adds CRO Users to the sponsor's P21E environment to work on specific Projects, Studies, and Data Packages together there. This is the best and most efficient option. ✅
Study License Share = A sponsor has a sponsor P21E environment, and a CRO has a separate CRO P21E environment. The Sponsor and CRO Users do not enter each other's environments. Instead:
The CRO Users work on a Study in their CRO P21E environment.
The CRO Users manually transfer datasets, Validation Report XLSX, define.xml etc. to the Sponsor via sFTP, etc.—outside of P21E.
The Sponsor Users revalidate that delivery in the Sponsor P21E environment.
The P21E Customer Success team ensures that any Study processed in both the CRO P21E environment AND the Sponsor P21E environment consumes only one license, counted against the Sponsor's P21E licenses only, and not against the CRO's P21E licenses.
✍️ Order Form Attachment
To be eligible for Study License Share:
Both the CRO and the Sponsor must have an active P21E subscription, and
the CRO has executed or amended their latest P21E Order Form to include the Terms & Conditions for Study License Share, and
the CRO shares the one-time addendum with their Sponsor, unique to each unique Sponsor–CRO pair, and once signed, submits this to their Customer Success Manager
⚙️ Action Steps for License Share
Your Customer Success Manager can guide you through the following steps, once the agreements above have been completed. Most of this is managed simply over email, which is backed up to our Enterprise Service Desk (ESD) ticketing system, and license consumption adjustment system.
CRO ABC: “Dear Sponsor, please email me, your P21E Customer Success Manager, and support@pinnacle21.com to approve me to share 5 licenses from your P21E subscription.”
Sponsor XYZ: “Dear CRO ABC, P21E CSM, and support@pinnacle21.com, I approve CRO A to share 5 of my licenses, named as follows:
STUDY_A, STUDY_B, STUDY_C, STUDY_D, STUDY_E.”P21E Staff: “OK, noted.”
CRO ABC creates 5 Studies in the CRO's P21E environment with the necessary naming conventions, e.g., Project name =
Sponsor XYZ, Study name =STUDY_A, Data Package Name =SDTMAt the end of the annual P21E subscription period for the CRO and/or the Sponsor, the Customer Success Manager ensures that our license consumption system has:
prevented those 5 Study licenses from being counted against the CRO’s licenses
allowed that those 5 Study licenses to count against the Sponsor’s licenses only
This process improves cooperation between Sponsors and CROs, and we are happy to facilitate partnerships throughout the industry.
👣 What's Next?
Learn more about Sponsor-CRO Collaboration.
Please email questions or feedback to support@pinnacle21.atlassian.net.