Preview Release  ·  Module 02 of 11 live now  ·  Remaining modules in active development  ·  Early-access licensing available
Sparsh Strategic Consulting
DOKIMA
by Sparsh Strategic Consulting  ·  doh-KEE-mah
ICH E6(R3) · GCP

GCP Training That Thinks Like an Inspector.

dokimazō  (δοκιμάζω)
Ancient Greek · To test until genuine quality is proven beyond doubt. The examination Athens required of every public official before office. Not assumed. Proven.

Half of all FDA investigator site inspections find GCP non-compliance. Informed consent is consistently among the highest-frequency findings across FDA and EMA inspections.

The sites that failed had complete training records. The problem was never knowledge. It was judgement. DOKIMA trains the judgement that prevents the finding.

50%+
EMA inspection findings rated critical or major · GCP Inspectors Working Group, 2023
#3
Informed consent — consistently top-five FDA finding
11
ICH E6(R3) principles — 13 inspection-readiness modules
COMPOSITE TRAINING CASE · Based on recurring inspection patterns
Illustrative Training Case · Not a real FDA document
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"Subjects enrolled on superseded consent form version following Protocol Amendment 3.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
Where DOKIMA Fits

DOKIMA does not replace baseline GCP training. It closes the judgement gap that remains after baseline GCP training is complete.

The Full Curriculum
11 Principles. 13 Modules.
ICH E6(R3) · Effective July 2025
01
Ethical Principles
Coming Soon
02
Informed Consent
▶ Live Now
03
IRB / IEC Review
Coming Soon
04
Science & Protocol
Coming Soon
05
Investigator Qualifications
Coming Soon
06
Quality by Design
Coming Soon
07
Proportionality & Risk
Coming Soon
08
Data Integrity
Coming Soon
09
Sponsor Oversight
Coming Soon
10
Trial Master File
Coming Soon
11
Investigational Products
Coming Soon
+2
Extended Modules
Deep-dive topics
Licensing
Built for three types of buyer.
Three tiers. One method. Every learner tested, not just trained.
Tier 1 · Sites
Investigator Sites
USD 2,600
per site · per year  ·  SGD 3,500 for Singapore-based sites
per site · per year
  • Unlimited staff access
  • Auto-certification, unique ID
  • Training records export
  • Annual content refresh
Tier 3 · Enterprise
Pharma / Sponsors
From USD 20,000
enterprise · contact for scoping
  • Unlimited sites, one programme
  • Custom inspection findings library
  • Co-branded certification
  • Dedicated QA advisory access
  • Full 11-principle suite · 13 modules
The Founder
Sachin Pasumamula
Quiet Watchdogs
Quiet Watchdogs
The Unsung Heroes of GxP · Amazon KDP

Sachin Pasumamula

Founder & CEO · Sparsh Strategic Consulting Pte. Ltd.

DOKIMA is built by a Quality Assurance professional with twenty-five years across the GxP lifecycle in pharmaceuticals and biotechnology, with engagement experience spanning twelve health authorities including the FDA, EMA, PMDA, MHRA, TGA, Health Canada, Anvisa, NMPA, MFDS, Taiwan FDA, DCGI and HSA.

The judgement DOKIMA trains is not theoretical. It is drawn from a career spent holding the line between commercial urgency and patient safety, and from asking the questions that matter before the inspector does.

25 yrs
GxP Quality Assurance
12
Health authorities engaged
Author
Quiet Watchdogs · SQIP inventor
Inventor of the patent-pending Sparsh Quality Intelligence Platform (SQIP) · linkedin.com/in/sachinpasumamula
Inside the Platform

See how it works.

Every module moves from a real inspection finding, through branching judgement, to a defensible examination. Here is what a learner sees.

01 · The Finding
The Finding Before the Failure
"Subjects enrolled on a superseded consent form following Protocol Amendment 3."
The site knew the rule. The site did not own the reasoning. That gap is the module.
02 · The Judgement
The investigator asks: walk me through the consent timeline.
A"That must be a documentation error."
B"Let me establish the actual sequence from the records."
Your decision changes what the inspector does next.
03 · The Proof
Certificate of Completion
Your Name
Examination Score: 83% — Passed
Tested until genuine competence was proven.
Earned at 80% or above. Never given.
The Build

11 principles. Built in order of inspection risk.

DOKIMA is released module by module, highest-risk principles first. Design-partner and early-access licensees shape the sequence.

Live Now
Informed Consent
Principle 2 · with branching case
Q4 2026
Data Integrity
Investigator Qualifications
Science & Protocol
Q1 2027
IRB/IEC Review
Quality by Design
Proportionality & Risk
Q2 2027
Sponsor Oversight
Trial Master File
Investigational Products
Ethical Principles
Get in Touch
Start a conversation.

Talk to us directly.

Whether you are exploring a pilot, asking about licensing, or want to understand how DOKIMA fits your inspection readiness programme — we respond within 24 hours.

About the Founder

Sachin Pasumamula is the Founder and CEO of Sparsh Strategic Consulting Pte. Ltd. with 25+ years of GxP quality assurance expertise across Asia Pacific. He is also the author of Quiet Watchdogs: The Unsung Heroes of GxP and the inventor of SQIP — the world's first Causal Quality Intelligence Platform (patent filed, Singapore, April 2026).

Send a Message
Your message will be sent to info@sparsh.sg · We respond within 24 hours · Singapore PDPA compliant