by Sparsh Strategic Consulting
ICH E6(R3) · GCP
ICH E6(R3) · Principle 2 · Informed Consent

GCP Training That Thinks Like an Inspector.

Half of all FDA investigator site inspections find GCP non-compliance. Informed consent appears in the top three findings — every single year. This is not a compliance module. It is a reasoning module. Built on real findings. Designed to change judgement, not just test recall.

50%+
EMA findings classified critical or major
#3
Informed consent — FDA annual top findings
13
ICH E6(R3) principles — one module each
REF: FDA-WL-2024-IC-007
Inspection Case File
MAJOR
"Subjects enrolled on superseded consent form version following Protocol Amendment 3. IRB-approved version not implemented at time of enrolment."
This finding was preventable. The site knew the rule. The site did not own the reasoning.
DomainInformed Consent
PrincipleICH E6(R3) · P.2
Subjects affected6 of 31
ClassificationMAJOR FINDING
Viveka trains the reasoning that prevents this
The Full Curriculum
13 Principles. 13 Modules.
02
Informed Consent
▶ Live Now
01
Subject Rights & Wellbeing
Coming Soon
03
IRB / IEC Oversight
Coming Soon
04
Investigator Qualifications
Coming Soon
05
Scientific Soundness
Coming Soon
06
Protocol Compliance
Coming Soon
07
Risk-Based Quality
Coming Soon
08
Investigational Product
Coming Soon
09
Data Quality & Integrity
Coming Soon
10
Confidentiality
Coming Soon
11
IP Manufacturing & Handling
Coming Soon
12
Quality Systems
Coming Soon
13
Systems with Electronic Data
Coming Soon
Licensing
Built for three types of buyer.
Tier 1 · Sites
Investigator Sites
SGD 3,500
per site · per year
  • Unlimited staff access
  • Auto-certification, unique ID
  • Training records export
  • Annual content refresh
Tier 2 · CROs · Most Selected
CROs
USD 4,500
per cohort · up to 20
  • Cohort management dashboard
  • Branded completion reports
  • SCORM export for LMS
  • Sponsor-facing audit trail
  • Priority content updates
Tier 3 · Enterprise
Pharma / Sponsors
USD 20,000
enterprise · per year
  • Unlimited sites, one programme
  • Custom inspection findings library
  • Co-branded certification
  • Dedicated QA advisory access
  • Full 13-principle suite