Check every PSP conversation, not a sample of it.
Patient support calls carry your adverse-event signal, your consent record, and your adherence story. Most quality control listens to a few percent of them. This checks all of them, in near-real-time, onshore.
Built for PSP 2.0 in China. Prepared for Syneos Health.
The conversation is the richest signal in the program, and the least controlled.
A patient support program runs on conversations. A nurse educator talks to a patient about how the therapy is going, which side effects appeared, whether the dose is right, whether they are still taking it. Those calls hold what matters most to a sponsor and a regulator: adverse events, consent, adherence. Today most of that signal is heard once, by one person, and then lost.
Quality assurance samples. A reviewer listens to a small share of calls after the fact. The rest is unverified. That gap is where the real exposures sit:
- Pharmacovigilance leakage. Adverse events mentioned on a call must be reported. Sampling cannot guarantee they all were. Under-reporting surfaces at inspection, not before.
- Off-label drift. A nurse who strays toward an unapproved use or a dosage suggestion is a direct liability for the marketing authorization holder. At scale, no one sees it happen.
- Consent integrity. Informed consent has to be obtained and recorded correctly, every time. Under PIPL, sensitive health data raises the bar further.
- The value-proof gap. Sponsors ask what the program is worth. The data that would show its effect on days-on-therapy and dropout is sitting in audio that gets discarded.
- Cost-to-serve. PSRs spend their time writing records instead of talking to patients, and the program economics reflect it.
In China there is one more gap. Global patient-engagement platforms were not built on WeCom, mini-programs, or Douyin, and they do not guarantee a PIPL-clean, onshore path for the original audio. Running this well in China takes a local layer.
What we check, and what we commit to.
The system checks each conversation across six categories. The same model runs whether the call is an enrollment, a routine follow-up, a serious-event escalation, or a compliance-sensitive exchange.
ICF obtained and recorded before any personal data is collected.
Required fields gathered: AE details, dosage, concomitant meds, adherence.
Mandatory messages said: how to report a side effect, administration, safety warnings.
Off-label, dosage advice, and comparative claims caught as they form.
Steps in the right order, none skipped (consent before data, AE interview after an AE).
Serious adverse events, pregnancy, product complaints, dropout intent.
Every completed conversation is quality-checked against these six categories, and the system assures collection completeness within seconds of a gap.
Prompting the PSR during the call, on a 4G route, is near-real-time: a few seconds end to end. We prove the latency and the onshore path before we promise them.
What it changes, in your terms.
| Capability | Pain it addresses | Outcome |
|---|---|---|
| 100% conversation QC | PV under-reporting, off-label exposure | Closes the audit gap. Every call checked, not a sample. |
| Near-real-time collection assurance | Missed required fields, post-visit rework | Fewer gaps caught while the patient is still there. |
| Onshore PIPL and GVP architecture | China data-localization risk | A defensible compliance posture, original audio never leaves your environment. |
| Longitudinal patient record | The value-proof gap | Days-on-therapy and dropout you can measure and show a sponsor. |
| Documentation automation | Cost-to-serve | PSR time back on patients, lower cost per interaction. |
| QC dashboard and KPI evidence | ROI questions from sponsors | A number to put in front of the brand. |
The China-local layer under your program.
We are not a CRO, and we are not here to replace your operation. We run underneath your patient support program as the part a global stack does not cover in China: the conversation intelligence in Chinese, the onshore compliance path, and the local engagement rails on WeCom and mini-programs.
Built once, the same architecture templates across your programs and sponsors. You carry the patient relationship and the brand. We make the conversation inside it verifiable, compliant, and measurable.
Onshore throughout · PIPL Art. 28 · GB/T 45574-2025 · NMPA GVP · the hardware vendor is not in the data chain
A proof of concept is the honest next step.
One program, one hospital setting. We validate the latency, the onshore path, and the Chinese medical transcription, and you see the quality control and the patient record on real conditions before anything scales.