Sponsor-CRO shares
Sponsor-CRO shares
“I’ve contracted with a CRO that’s been using Pinnacle 21 Enterprise for years. As the sponsor, I’m paying for the license to add my study, but they are doing the work in their environment. So I don’t really need Pinnacle 21. They’ll send me my data packages once they’ve validated them. And they can give me access to their environment if the need ever arises.”
If your CRO has a Pinnacle 21 environment, they can leverage all the benefits of the platform. Whether they do leverage them for your study is a separate question. Without your own license, you can’t fully tap into those benefits, including:
✅ Detailed issue logs from validation checks
✅ Issue management
✅ Define.xml creation
✅ Data Reviewer’s Guide creation
✅ and more
Also, without your own license, you will always be at one remove from the work itself, which makes fine-grained quality control nearly impossible. Chances are you’ll receive clean, validated data packages from your CRO. You can even check for yourself by running those packages through the validation engine on Pinnacle 21 Community. But the output there won’t provide an impact score for each issue. You’ll only know if you’ll avoid technical rejection upon submission.
As for “letting you in”, your CRO is contractually prohibited from granting you access to their environment. Granting you access to their environment exposes studies run by your competitors.
Fortunately, there are simple solutions that allow you and your CRO partners to work together in the same environment, or in parallel, without adding cost.
The Sponsor-CRO Environment Share
If you already have a Pinnacle 21 environment, you may invite CRO users into your environment, sharing only those studies for which you’ve contracted them. This gives you visibility into how they are progressing on your datasets and submission deliverables.
The Sponsor-CRO License Share
On the other hand, the CRO may want the freedom to work in their own private environment before sharing progress with you. And you may want to grant them that freedom. After all, it’s the results that matter!
As the sponsor, you’ve already paid for a Pinnacle 21 license for your study. That license just happens to live within the CRO’s environment. You don’t want to pay for a second license to mirror that study in your environment. The good news? You don’t have to.
For your next study, retain the license in your own environment and tell us the name of the CRO working on your study. We will work with you and the CRO to load the study into your environment and theirs. This will not incur an additional charge to the CRO (you are sharing the license you’ve paid for), so there is no additional pass-through to you.
Sharing is Caring
Having your own Pinnacle 21 Enterprise license means both you and the CRO avoid data security risks. With your own license comes your own environment – which means your intellectual property is held securely in its own separate location. If they wish, your CRO can continue to work through day-to-day issues in their own environment. Meanwhile, you’ll have greater insight into the quality of every data package they deliver, along with the tools to prepare other submission deliverables.
Get all that you’ve paid for and discover what Pinnacle 21 has to offer!