Terms of Service
In short
- Your data and the programs and outputs made for you are yours. We use them only to run the service for you.
- Every year 30 ADaM data sets and 300 TLFs are free. Everything you make on the public service is public, with your name on it: use simulated data only.
- Clinwright writes and runs programs with the help of AI. You review and sign what you deliver; you stay responsible for your submissions and for validating your use of the service.
- The public service is free and sells nothing; its AI runs only with your organization’s own Anthropic key, under your agreement with Anthropic. Private work is on a dedicated server, under a separate contract.
The public edition: Clinwright now runs as a free public service only. Nothing is sold on it, so the sections on credits, payments, the archive fee and refunds (3, and the parts of 4 and 9 about them) do not apply until we announce paid plans, with at least 30 days’ notice. The service has no AI of its own: where these terms speak of the AI, it is the one your organization reaches with its own key, and what that provider charges is between you and it.
1. Who we are and what these terms cover
Clinwright is provided by Helper Software LLC, 300 US Highway 202, Suite 5, Unit 1016, Raritan, New Jersey 08869, USA (“we”, “us”). These terms govern your use of the hosted Clinwright service at app.clinwright.com, its public pages and its documentation (the “Service”). By creating an account, joining an organization or using the Service, you agree to them. If you use the Service for a company or other organization, you agree for it, and confirm that you may.
An Enterprise agreement, an order form or a self-hosting license signed with us takes precedence over these terms where they differ.
2. Accounts and organizations
- You must be at least 18 and give accurate information. One account is for one person; do not share it.
- Work happens in organizations. The organization’s owners and administrators invite and remove members, choose its plan and may export or delete its work. If your employer or client invites you, they control the organization and its content, not you.
- Keep your password secret and turn on two-step verification where your work calls for it. Tell us at once at support@clinwright.com if you think someone else has used your account.
3. Credits and payment
- Every organization has a free allowance each year (counted from its creation): on the public service 30 ADaM data sets and 300 TLFs (tables, listings and figures). Beyond it, once credits are sold, you buy credits for ADaM data sets and TLFs, separately, in any quantity, at the prices shown in the Service when you buy (larger quantities in one order cost less per unit).
- An ADaM data set or a TLF counts once per reporting effort, when its program is first delivered having passed its checks: against the free allowance first, then against your oldest credits. Re-runs, new database releases and revisions do not count again. A new reporting effort (for example a final analysis after an interim one) counts its data sets and outputs again.
- Credits are paid in advance, through our payment processor, Stripe, and are usable for 12 months from their purchase; unused credits then expire. Prices are in US dollars and exclude taxes, which we add where the law requires. Nothing renews or is charged automatically.
- We may change prices; a change applies to purchases made after it, never to credits already bought.
- Refunds: if you are not satisfied, ask within 30 days of a purchase for a refund of its unused credits. Archive fees, and credits used, are not refundable except where the law requires.
4. Free organizations are public
Everything an organization that has never bought credits makes (specifications, data presentation specifications, programs, outputs and the like) is published on public pages under the organization's name, with its authors' names, and may be indexed by search engines. You grant everyone a non-exclusive, worldwide, royalty-free right to view, copy and reuse that public content. Such an organization works on simulated data only: uploading data is not available to it, and you must not put confidential or personal information into its content. Buying credits makes the organization's work private from then on; copies others made while it was public cannot be recalled.
On the free plan the AI is unlocked by verifying a payment card: the card is saved by our payment provider without any charge, and each card unlocks one organization. Organizations have daily limits on how long their programs run and on how many console runs wait at once (shown on the Plan and billing page; larger after buying credits), and requests to the Service are limited in rate. You must not create accounts or organizations to get around these limits.
5. Your content
- “Your Content” is what you or your organization put into the Service (specifications, data, documents, settings, comments) and what the Service makes for you from it (programs, data sets, outputs, define.xml files, reports). As between you and us, Your Content belongs to you or your organization.
- You give us the rights we need to host, copy, process, run, display and transmit Your Content to provide, secure and support the Service for you, including sending it to the subprocessors listed on our subprocessors page. We do not sell Your Content, and we do not use the content of paid plans to train AI models or to improve the Service for others.
- You confirm that you have the rights and permissions needed for Your Content, including any consents and approvals for clinical trial data. Clinical data you upload must be de-identified or pseudonymized: do not upload names, contact details or other directly identifying information about trial participants. The Service is not intended for protected health information under HIPAA, and we do not sign business associate agreements under these terms.
- Where Your Content includes personal data, our Data Processing Agreement applies and forms part of these terms.
6. AI, programs and your responsibility for results
The Service uses AI models to configure specifications and to write programs, and runs those programs to produce data sets and outputs. AI can be wrong, and a program that passes its checks can still be wrong for your study. You are responsible for reviewing what you deliver, for independent quality control (such as double programming), for validating your use of the Service in regulated work (for example under 21 CFR Part 11, EU GMP Annex 11 and ICH E6), and for everything you submit to a regulator or use for a decision. The Service keeps an audit trail and records each run so that you can do this; it does not do it for you.
Programs run in an isolated environment without network access, with SAS-language programs run by an independent engine that is not SAS. Results may differ from those of SAS® software in edge cases.
7. Acceptable use
You must not, and must not let others:
- break the law, infringe others’ rights, or upload malware;
- probe, test or get around the isolation of program runs, the separation between organizations, quotas, or other security or usage limits, except in a security test we have agreed to in writing;
- overload the Service, scrape it, or access it by automated means other than the interfaces we provide;
- resell the Service, or use it to build a competing product;
- reverse engineer it, except where the law allows despite this limit.
Found a security problem? Tell us at support@clinwright.com; we will not pursue good-faith research that respects people’s data and stops at proof of the problem.
8. Our responsibilities
- We protect Your Content with the measures described in our Data Processing Agreement, keep paid plans’ content confidential, and give our staff access to it only to run, secure and support the Service, or when you ask us to.
- We aim to keep the Service available and back it up every day; there is no service-level commitment except in an Enterprise agreement. We may change the Service, and will tell you in advance of changes that remove features you use.
- The Service uses open standards and third-party components, including CDISC standards and open-source software, each under its own license.
9. Keeping, archiving and deleting your work
- You may stop using the Service at any time. Owners can export all of an organization's work, in common formats.
- A private organization stays active for 12 months after its latest purchase of credits, with 50 GB of files included. After that it is archived: private, readable and exportable, but nothing new is made in it until credits are bought again. The archive keeps it for a fee (currently US$60 a year per organization).
- An organization kept neither by credits nor by the archive, and a free organization nobody has signed in to for 12 months, is deleted. We tell its owners by email 60, 30 and 7 days before; signing in (free organizations), buying credits or paying for the archive keeps it.
- A deleted organization, whether deleted by its owners or as above, can be restored for 30 days; then it is erased, and it leaves our backups within a further 30 days. You can delete your own account at any time from your account page; see the Privacy Policy for what is kept.
- We may suspend or end your access if you seriously or repeatedly break these terms, if the law requires it, or to protect the Service or others. Where we can, we tell you first and give you the chance to fix the problem and to export your work.
- If we stop offering the Service, we will tell you at least 90 days in advance and refund unused credits and the unused part of archive fees.
10. Warranties and liability
Except as these terms say, the Service is provided “as is” and “as available”, without warranties of any kind, express or implied, including merchantability, fitness for a particular purpose and non-infringement, to the extent the law allows.
To the extent the law allows: neither party is liable for indirect, incidental, special or consequential damages, or for lost profits, revenue or data, even if told they were possible; and each party’s total liability arising out of these terms in any 12 months is limited to the amounts paid and payable by you to us for the Service in those 12 months (or US$100 if you only use the free allowance). These limits do not apply to your payment obligations, to a party’s indemnification obligations, or to liability that the law does not allow to be limited.
You will defend and indemnify us against third-party claims arising from Your Content or from your use of the Service in breach of these terms. We will defend and indemnify you against third-party claims that the Service, as we provide it, infringes their intellectual property rights.
11. Changes to these terms
We may change these terms. For changes that matter, we tell you by email or in the Service at least 30 days before they take effect, and ask you to agree to them at your next visit. If you do not agree, you may stop using the Service and, ask for a refund of credits not yet used.
12. General
- These terms are governed by the laws of the State of New Jersey, USA, without regard to its conflict-of-laws rules. The state and federal courts located in New Jersey have exclusive jurisdiction, except that either party may seek urgent relief in any competent court. Mandatory consumer-protection laws of your country are not affected.
- You must comply with export-control and sanctions laws, and must not use the Service from a country or for a person under comprehensive US sanctions.
- If a provision is unenforceable, the rest stays in force. Not enforcing a provision is not a waiver. You may not transfer these terms without our consent; we may transfer them to a successor of the Service, telling you in advance.
- SAS is a registered trademark of SAS Institute Inc.; CDISC, SDTM and ADaM are trademarks of the Clinical Data Interchange Standards Consortium. Clinwright is not affiliated with either.
Questions: support@clinwright.com.