D
Diabeasy / Sponsor
A Caresoft programme
AM
RWE
VAULT
Premium evidence tier · Audit-controlled access

Real-World Evidence Data Vault

De-identified longitudinal records aggregated under ICMR National Ethical Guidelines (2017) and the DPDP Act 2023. Exportable for medical affairs, regulatory submissions and peer-reviewed publication.

Total records
1,247,392
Across 38,420 enrolled patients
Atlas/ Sponsor Portal/ Real-World Evidence Vault
Premium Tier

Data Vault & Evidence Exports

Reusable, audit-trailed, longitudinal — sold separately from the core PSP licence as outcomes data products.

Demographics

Patient register

38,420
22 fields · age, sex, BMI, region, comorbidities
Completeness98.4%
Lab values

HbA1c & biochemistry

186,420
12 fields · HbA1c, FBS, PPBS, lipids, eGFR
Paired baseline+12mon=8,142
Pharmacy

Refill records

428,180
9 fields · drug, dose, fill date, source pharmacy
Validated100%
Patient-reported

Glucose logs

512,640
5 fields · timestamp, value, context, source
App-verified87%
Clinical

Consultation notes

82,732
structured + free-text · NER-tagged
Encoded ICD-1091%
Export Builder

Compose a data export request

Each request enters review queue. Audit trail captures requester, purpose, fields and SHA hash of delivered file.
Purpose
Medical affairs publication Regulatory submission Internal analytics Health economics study Conference abstract
Cohort
All Care+ enrolled (n=38,420) Ryzodeg only Tresiba only Insulin-naïve subset 12-mo paired HbA1c (n=8,142)
Variables
Demographics Baseline HbA1c Follow-up HbA1c MPR Refill timeline Glucose self-monitoring Concomitant therapies Adverse events Comorbidities + 14 more
Time window
90 days 6 months 12 months Programme-to-date Custom date range
De-identification
HIPAA Safe Harbor (18 identifiers removed) k-anonymity (k=5) Aggregated only (no patient-level)
Format
CSV Parquet SAS XPT CDISC SDTM Statistical summary PDF

Export history & downstream artifacts

Every export creates a permanent audit record
Request ID Purpose Cohort Records Hash Status Requested
RWE-2026-0142 Medical affairs publication
"Real-world adherence with co-formulated insulin"		 12-mo paired cohort 8,142 0x4F2E…A91C Delivered 02 May 2026 Audit log →
RWE-2026-0138 Health economics study
Cost-per-outcome analysis · payer pitch		 Programme-to-date 38,420 0x71BE…F03A Delivered 28 Apr 2026 Audit log →
RWE-2026-0141 Conference abstract
RSSDI 2026 · poster		 South India subset 12,840 pending Ethics review 08 May 2026 View request →
RWE-2026-0140 Regulatory submission
CDSCO post-marketing surveillance		 Full safety cohort 38,420 0x91AB…E2D7 Delivered 15 Apr 2026 Audit log →
RWE-2026-0139 Internal analytics
Brand strategy review		 Discontinued cohort 2,586 0x3D9F…7B12 Delivered 12 Apr 2026 Audit log →
142 exports YTD · 3 publications in preparation · 1 conference abstract accepted
Compliance Posture

Regulatory & Ethical Framework

Data protection
  • DPDP Act 2023 — consent, purpose limitation, deletion rights
  • ISO 27001:2022 — certified Mar 2026
  • HIPAA Safe Harbor — 18-identifier de-identification
  • SOC 2 Type II — audit cycle in progress
Research ethics
  • ICMR National Ethical Guidelines (2017) — secondary use
  • Independent IRB review · MEC of Caresoft Systems
  • CDSCO post-marketing surveillance template
  • STROBE / RECORD-PE reporting alignment
DPDP
2023
VERIFIED
DOC-ID: PSP-NN-2026-04 / RWE-VAULT DATA-STEWARD: Dr. Meera Iyer, Caresoft MEC
All exports logged · Vault audit cycle: monthly