Ready for your vendor qualification
SOC 2 Type II report, an audit against your own checklist, and GDPR documents at onboarding.
What your qualification reviewer can check
Your QA team receives the documents behind these items in the qualification pack.
SOC 2 Type II
Independent audit of our security controls; the report is in the qualification pack.
Your data
Pseudonymized IDs, with encrypted transfer; processed and stored in the EU or US. The sponsor owns the study data, delivered by CSV, Parquet, API or into your eCOA or EDC.
Electronic records
Audit trail, role-based access and versioned analysis, designed to support 21 CFR Part 11 and EU Annex 11 requirements.
Traceability
Analysis version and named features on every reading; device, OS build and app version where the recording app provides them, otherwise the processing period, read from the audio.
Qualification packSent to your QA team
- SOC 2 Type II
- Independent audit report
- Quality management
- Structured on ISO 13485 principles
- Electronic records
- Designed to support 21 CFR Part 11 and EU Annex 11
Built for special-category data under GDPR
Speech recorded to measure health is health data under GDPR, handled from consent to withdrawal.
GDPR
DPIA, ROPA and a DPA for your study at onboarding. Retention and deletion agreed before any transfer, including recordings sent for Trial QC or re-analysis.
Consent
Consent to recording can be given separately from consent to trial participation.
Withdrawal
Collection stops; recordings already made are kept or deleted as the protocol and consent specify.
US participants
Designed to support HIPAA requirements, with a business associate agreement (BAA) where HIPAA applies.
A documented quality system behind every reading
Records your QA and regulatory teams can inspect, from capture to analysis.
Quality management
Our software is developed under a documented quality management system structured on ISO 13485 principles.
Quality at capture
Where Cephalgo records, noise, clipping and speech duration are checked during the session, with a retake requested before the session ends.
Regulatory
Evidence organized by context of use, to support your FDA and EMA interactions.
Validation evidence
Each measure evaluated stage by stage following the DiMe V3 framework, one indication at a time, and your study’s validation report follows the TRIPOD+AI guideline.
Qualification in two steps
You set the checklist; we supply the documents at each step.
Qualification pack
The documents listed above, sent to your QA team.
Remote or on‑site audit
At your request, against your own checklist.
Optional, at any step
If you have one, send your RFI, RFP or security questionnaire.
Who you contract with
Cephalgo SAS (société par actions simplifiée), founded October 2021 in Strasbourg, France.
Registered office
8 rue des Veaux, 67000 Strasbourg, France
Registration
RCS Strasbourg 904 447 323
VAT
FR72904447323
Share capital
€45,168
