Terms of Service

1. These terms, and who they apply to

These terms cover your use of Dagnul, software that reads copies of the intake streams other teams run and puts every possible adverse-event report in Drug Safety's queue on the day it arrives, for a safety scientist to confirm or correct. They are a contract between Dagnul, Inc., of 451 D Street, Suite 702, Boston, MA 02210, United States (“Dagnul”, “we”) and the company that signs up (“Customer”, “you”).

The service is for businesses only, not consumers. By signing up you confirm that you are acting for your business and that you have the authority to commit your company.

The person who accepts these terms accepts them for the company, not for themselves. If you don’t have that authority, please don’t go ahead.

If documents disagree. This order applies: (1) a signed order form or agreement between us, (2) the data processing agreement, (3) these terms, (4) our Privacy Policy, (5) anything else on our website.

2. What the service is

Dagnul is a web app for your Drug Safety team. Your head of pharmacovigilance switches on the intake streams it reads (a medical-information inbox, a call-center contractor's notes, your own social pages, market-research and patient-support forms, sales-rep call notes) and names the team that owns each; each stream's owner sends us copies through a copy rule or a read-only connection. Our model reads each item as it arrives, in English or Spanish, and proposes whether it is a possible adverse-event report, which of the four minimum criteria it holds, a seriousness and a day zero, each beside the sentence it came from. Each item goes into your intake queue, the owning team is told, and one of your safety scientists confirms or corrects every proposal. Their corrections retrain your model at the retraining your head of pharmacovigilance approved in the change control plan, and a new version reads nothing until she signs its test report. Every step is dated in the item's trail, which is kept for ten years and exported to you each quarter. Before any of this you can have the handoff count: the median calendar days from day zero to Drug Safety's receipt on your last quarter, stream by stream.

3. What the service is not

These limits are deliberate, and they are part of what you are buying. They are not defects.

Not case processing. We do not code cases in MedDRA, write narratives, assess causality, send follow-up requests, build E2B(R3) messages or submit anything to FDA. A confirmed item reaches your safety database as a source document, and your case processors take it from there.

Not a decision on any case. Every mark the model makes is a proposal. As the applicant you remain responsible for every case, for the timelines and for your written procedures, including the parts you contract to us.

Not an automatic closer. The model closes, nullifies and answers no item, including the ones it proposes are not cases. Those wait in a daily list for one of your scientists.

Not literature, audio or image screening. We do not search medical literature, listen to call recordings or read images and scans. Your literature search stays as it is, and recordings and images reach your queue unread.

Not an installation. Dagnul runs only as our service on cloud infrastructure in N. Virginia. We do not install it on your servers or in your cloud account.

4. What you need to do, and why it matters

What you get from the service depends a lot on things only you control. Please read this section carefully, because sections 9 and 10 build on it.

Switch on streams and name their owners. Only your head of pharmacovigilance switches a stream on or off and names the team that owns it. We read nothing from a stream she has not switched on.

Keep the copies coming. Each stream's owner, or the contractor or agency working for it, keeps its copy rule or connection in place. Getting their agreement to send copies to us is yours. If a stream goes silent we tell your head of pharmacovigilance, but an item that never reached us is not one the model can read.

Confirm every item. Your safety scientists confirm or correct every item in the queue and clear the daily not-a-case list by the next working day. An item nobody confirms stays in the queue; the clock on it is yours.

Validate and sign. Your head of pharmacovigilance writes the acceptance criteria into the validation plan, approves the change control plan, signs each model version and each change to a stream's line, and keeps the description of the service in your written procedures current.

Enter and submit cases. Confirmed items are entered in your safety database and submitted by your case processors within the legal timelines, counted from the day zero your scientists confirmed.

Have a legal basis for the data. You decide why patients' and reporters' data is processed and make sure you may send it to us under the data processing agreement.

5. Getting started, and what is free

The handoff count on last quarter's logs costs nothing and needs only the data processing agreement, signed first. If you do not go on, the exports are deleted within 30 days of the count.

Your first stream runs for six weeks beside your own reconciliation before the first invoice, with the same model, queue, trail and support as a paid stream. If at the end of the six weeks your head of pharmacovigilance does not sign the stream live, the contract ends and you owe nothing.

6. Fees

Plans by streams read. One stream is $890 a month, Three streams $1,990 and Every stream, with no cap on the number, $2,990, invoiced monthly in advance from the day your head of pharmacovigilance signs the first stream live. A change of plan takes effect from the next month.

What is not counted. The invoice carries no charge for items, cases, users or owning teams, for connecting a stream or the six-week parallel run, for retraining, for the validation package and each version's test report, for one supplier audit a year, for the quarterly export or for the archive after the contract ends.

Tax. Prices are in US dollars and exclude sales tax, which is added where the customer's state taxes the service.

Price hold and notice. The price you sign at holds for 24 months from your first invoice, and any later change is announced 90 days ahead. You can leave with 30 days' notice, effective at the end of the billing month in which the notice ends.

7. Delivery, availability and support

Reading time. An item that reaches us is read and in your queue within 30 minutes of arriving. If the model is unavailable, items go into the queue unread within the same time and are marked so, so nothing waits on the model.

Silence alerts. Each stream's usual gaps are learned during the parallel run. When a stream sends nothing for longer, we email your head of pharmacovigilance the same day, because a broken copy rule looks like a quiet week.

Model versions. Retraining runs on the cadence in your change control plan, monthly unless your head of pharmacovigilance sets another. A new version is switched on only after she signs its test report, and the previous version stays ready for 90 days so she can switch back.

Support. Support is by email and phone in English on US business days, 8 a.m. to 6 p.m. Eastern time. A queue that does not load or a stream that stops is answered within one hour in those hours.

Support. Support is by email at [email protected]. We aim to reply within one business day. That is a target, not a guarantee.

8. The item trail, model versions and corrections

The item trail. Every item carries a dated trail: when it arrived and from which stream, what the model proposed and which model version proposed it, who confirmed or corrected it and when, and the case number the safety database gave it. Trail lines are appended and never rewritten.

Model versions and test reports. Each version of your model is kept with its training date, the pairs it was trained on, its result on the held-out test set against your acceptance criteria and your head of pharmacovigilance's signature, for as long as any trail it appears in is kept.

Correcting the record. If a confirmation or a day zero was wrong, one of your scientists adds a correction with a reason. The original entry stays readable beside it, and both are dated.

Exports. Every quarter, and whenever you ask, the trails, the streams page and the version history are exported to you as PDF/A and CSV, so your record does not depend on our service.

9. What we promise, and what we don’t

We promise to provide the service with reasonable skill and care, and that we have the right to provide it.

We do not promise that the model finds every case, proposes the right seriousness or the right day zero, or reads an item that never reached us because a copy rule or connection was changed on your side or a contractor's; every mark it makes is a proposal for one of your scientists to confirm or correct. We do not promise that a stream's line, once signed, stays right as the stream changes, which is why every change to it is signed again.

Beyond that we give no other warranty. As far as the law allows, we exclude all implied warranties, including merchantability, fitness for a particular purpose and non-infringement.

10. Liability

10.1 Neither of us limits liability for death or personal injury caused by negligence, for fraud or fraudulent misrepresentation, or for anything else the law says can’t be limited.

10.2 Losses neither of us covers. Neither of us is liable for lost profit, revenue, expected savings, business, goodwill or reputation, or for any indirect or consequential loss, however it arises.

10.3 Specific exclusions. We are not liable for a late or missing submission to FDA, for a case your scientists confirmed, corrected or left unconfirmed, or for an FDA inspection finding or enforcement action, which stay with the applicant under the law; for items that never reached us because a stream's copy was stopped or changed outside our service; or for what your safety database, its case processors or your contractors do with a confirmed item.

10.4 Cap. Our total liability to you in any 12-month period is limited to the fees you paid us in that period, or $25,000 if that is more. Loss we cause by fraud, willful misconduct or gross negligence falls outside the cap, and so does a breach of the data processing agreement in our handling of patient data, which is capped at three times that amount.

10.5 You accept that the limits in sections 9 and 10 are a fair way to share risk, given the price and your part under section 4, and that we could not offer the service at this price without them.

11. Confidentiality and data

Your items, case lists, proposals, corrections, handoff counts, streams page, model versions and test reports, and the fact that you use Dagnul, are your confidential information. We use them only to run your intake and do not disclose them to anyone, except to an inspector or a court where the law requires it and with notice to you where the law allows.

How we handle personal data is set out in our Privacy Policy and in the data processing agreement between us, which forms part of these terms. If the DPA and these terms disagree about personal data, the DPA wins.

12. Who owns what

The app, the connectors, the base model and the corpus it is trained on, and our validation templates are ours, and run only as our service.

Your items, trails, handoff counts and exports are yours. Your own model layer is trained only on your pairs and used only for you; it is deleted with the pairs when the contract ends. The validation package and test reports we write for you are yours to keep and to cite in your written procedures and in FDA inspections.

You may not use our name or logo in public, and we may not use yours, without written permission first.

13. How long this lasts, and how it ends

13.1 The contract starts when you sign up and runs until one of us ends it.

13.2 You can end it. Cancel at any time. It takes effect at the end of the current billing month, unless section 6 sets a minimum term.

13.3 We can end it. We can end it with 30 days’ notice. We can end it immediately if you seriously break these terms and don’t fix it within 14 days of being told, if you become insolvent, or if your use exposes us to legal risk.

13.4 What happens then. We stop delivering and stop billing. You keep everything already delivered to you, and your right to use it continues. We delete or return our working copies as the DPA says. Sections 9, 10, 11 and 12 continue to apply.

14. Changes to these terms

We may update these terms. A change that matters takes effect 30 days after we email you about it. If you don’t accept it, you can end the contract before then. Using the service after that date means you accept the change.

15. Contact

Dagnul, Inc., 451 D Street, Suite 702, Boston, MA 02210, United States
[email protected]

← Back