Distribution is easy. Proving acknowledgement is the work.
Sending a SUSAR letter takes a moment. Proving, months later, that a named investigator received and read a specific version is what takes weeks — because the evidence is a mailbox.
- Recipient targeting
- Per-person acknowledgement
- Escalation
- Filed evidence
- Recipients targeted
- 38
- Acknowledged
- 31
- Outstanding
- 7
- Overdue · escalated
- 2
- Evidence filed to eTMF
- Automatic
Per named person, not per site.
Distribution and evidence, without a third party.
The two usual options are a mail merge, which produces no evidence, or a vendor whose system knows nothing about your sites. Running it beside the delegation log removes both problems.
The recipient list builds itself
Derived from active sites and current delegation — who is there today, not who was.
Acknowledgement is a record
A named person confirms against their own account, for a specific version, with a timestamp.
Chasing is part of oversight
Outstanding acknowledgements appear in the CRA's preparation for that site's next visit.
Evidence files itself
Letter, version, recipients and acknowledgements land in the eTMF and each site file.
No extra vendor, no extra contract
One platform, one contract, one login. A vendor is another onboarding and another integration.
Sign-off before it goes out
Medical and regulatory approval gates distribution, rather than being a convention.
From letter to filed evidence.
Prepare
The letter is drafted or uploaded and versioned. Medical and regulatory sign-off is recorded before it can be sent.
Target
Recipients are derived from active sites and current delegation, so the list reflects who is actually there today.
Distribute
Each recipient is notified individually and sees the letter against their own account.
Acknowledge
Recipients confirm receipt per person and per version. The record is attributable and timestamped.
Escalate
Outstanding acknowledgements are reminded, escalated, and surfaced in monitoring visit preparation.
File
Letter, recipient list and acknowledgement record file to the eTMF and each site file automatically.
The parts that carry the evidential weight.
Sign-off before send
Medical and regulatory approval recorded as a gate, not as a convention.
Derived recipients
Built from active sites and current delegation rather than a maintained list.
Per-person delivery
Each recipient receives it against their own account, not a shared site mailbox.
Attributable acknowledgement
Who confirmed, which version, when — recorded rather than inferred.
Outstanding visible
The chase list is part of oversight, visible to CRAs preparing their next visit.
Evidence filed
The full distribution record files to the eTMF and site files as it is produced.
Common questions
How is the recipient list determined?
From the study's own records — which sites are active, who is currently delegated at each, and which roles a given letter must reach. It is derived rather than maintained as a separate distribution list, which is what stops it going stale.
What counts as acknowledgement?
A named recipient confirming, against their own account, that they have received and read the specific letter version. It is recorded per person with a timestamp, not inferred from an email open or a site-level reply.
What happens to recipients who do not acknowledge?
They stay outstanding and visible. Reminders can be sent, and the outstanding list is available to the CRA preparing the next monitoring visit, so chasing happens as part of normal oversight rather than as a separate campaign.
Is the evidence filed automatically?
Yes. The letter, its version, the recipient list and the acknowledgement record file to the eTMF and to each site's own file as they are produced.
Connected in the same platform
Bring a safety letter distribution you had to evidence.
30 minutes with a founder. We'll run the distribution and show what the acknowledgement evidence looks like at the point an inspector asks for it.