End-to-End Biometrics · Submission Ready

Where rigorous data
meets regulatory
precision.

Principal-level statistical programming, biostatistics, and regulatory submission biometrics — built for FDA, EMA, and PMDA. Inspection-ready deliverables from Phase I through NDA/BLA submission, without remediation at the end.

Scope Your Engagement → Explore Services
Principal-level experience across leading global CROs & pharma
13+ Years· Phase I–III· 12+ Therapeutic Areas· FDA · EMA · PMDA
13+
Years’ biometrics
experience
AUDIT
READY
Every deliverable
FOREST PLOT · HAZARD RATIO · PRIMARY EFFICACY ENDPOINT AUDIT READY HR 1.0 Subgroup A 0.72 [0.58, 0.89] Subgroup B 0.79 [0.63, 0.99] Subgroup C 0.65 [0.50, 0.84] Overall 0.68 p < 0.001 95% CI: 0.54–0.86 CDISC ADaM Submission Package eCTD MODULE 5 KAPLAN–MEIER · OVERALL SURVIVAL (ADTTE) · n=575 1.0 .75 .50 .25 Treatment (n=286) Control (n=289) 0 12 24 36 mo SDTM 3.4 · ADaM 1.3 · PINNACLE 21 VALIDATED · 21 CFR PART 11
CDISC SDTM 3.4• ADaM 1.3• define.xml 2.1• Pinnacle 21 Enterprise• ICH E9(R1) Estimands• eCTD Module 5• FDA · EMA · PMDA• 21 CFR Part 11• SAS 9.4• ISS / ISE Integration• NDA / BLA / MAA• SDRG & ADRG• CDISC SDTM 3.4• ADaM 1.3• define.xml 2.1• Pinnacle 21 Enterprise• ICH E9(R1) Estimands• eCTD Module 5• FDA · EMA · PMDA• 21 CFR Part 11• SAS 9.4• ISS / ISE Integration• NDA / BLA / MAA• SDRG & ADRG•
13+
Years’ Experience
Phase I through NDA/BLA submission biometrics — full stack
12+
Therapeutic Areas
Oncology, gene therapy, CV, rare disease, neurology & more
Audit
Ready
Every Deliverable
Regulatory documentation built in from day one — never retrofitted
FDA
EMA
PMDA
Regulatory Agencies
Multi-regional submission experience — all three major agencies
Track Record

Principal-level
experience, at scale.

13+ years across the full biometrics stack — CRF review to eCTD submission — at the world’s leading CROs and across all three major regulatory agencies.

Phase I – IIIFull Spectrum
SAS CertifiedAdvanced Programmer
CDISC SDTM 3.4Data Standard
ADaM 1.3Analysis Data
define.xml 2.1Submission Metadata
Pinnacle 21Validation
ICH E9(R1)Estimands
eCTD Module 5Regulatory
21 CFR Part 11Compliance
NDA / BLA / MAASubmission Types
ISS / ISEIntegrated Summaries
Principal LevelEvery Deliverable
Phase I – IIIFull Spectrum
SAS CertifiedAdvanced Programmer
CDISC SDTM 3.4Data Standard
ADaM 1.3Analysis Data
define.xml 2.1Submission Metadata
Pinnacle 21Validation
ICH E9(R1)Estimands
eCTD Module 5Regulatory
21 CFR Part 11Compliance
NDA / BLA / MAASubmission Types
ISS / ISEIntegrated Summaries
Principal LevelEvery Deliverable
FDA
CDER / CBER · United States
EMA
European Medicines Agency
PMDA
Pharmaceuticals & Medical Devices · Japan
eCTD
Module 5 Submission-Ready
What We Deliver

Three pillars. One integrated team.

Every deliverable inspection-ready from first draft — built to clear FDA, EMA, and PMDA review without end-of-programme remediation.

01 · BIOSTATISTICS

Biostatistics &
SAP Development

Statistical Analysis Plans authored to ICH E9(R1) estimand framework — pre-specified, documented, and fully traceable from protocol through final analysis report and regulatory submission.

SAP / SARICH E9(R1)EstimandsSample SizeAdaptive DesignMissing Data
Discuss your programme →
02 · PROGRAMMING

CDISC Statistical
Programming

SDTM and ADaM in SAS — Pinnacle 21 clean on first run. TLF production with validated shell libraries and full traceability. Programming specifications maintained throughout for regulatory archive.

SDTM / ADaMTLF Productiondefine.xml 2.1SAS 9.4Pinnacle 21ADRG / SDRG
Discuss your programme →
03 · REGULATORY

Regulatory Submission
Biometrics

NDA, BLA, MAA, and CSR biometrics packages for FDA, EMA, and PMDA — ISS, ISE, Reviewer’s Guides, define.xml, and eCTD-ready datasets. Full audit trail structured for agency reviewers from day one.

NDA / BLA / MAAISS / ISECSReCTD Module 5FDA · EMA · PMDA
Discuss your programme →
End-to-End Delivery

From protocol to eCTD submission.

Five integrated stages — each with full documentation, traceability, and principal review before handoff to the next stage.

01
Protocol &
CRF Review
Protocol feasibility
CRF annotation review
Data collection gap analysis
Biostatistics
02
SDTM Mapping
& Programming
SDTM 3.4 mapping specs
Pinnacle 21 validation
define.xml 2.1
Statistical Programming
03
SAP &
Analysis
Statistical Analysis Plan
ICH E9(R1) estimands
Pre-specified sensitivity
Biostatistics
04
ADaM Programming
& TLF Production
ADaM 1.3 datasets
ADSL, ADAE, ADLB, ADTTE
ADRG & traceability
Statistical Programming
05 ★
Submission
Package
TLFs · CSR sections
ISS / ISE · Reviewer’s Guides
eCTD Module 5 · All agencies
Regulatory Submission
Jagadeesh Thandlam
Jagadeesh Thandlam
Founder · Principal Statistical Programmer
MSc Biotechnology & Management · University of East London
Certified Advanced SAS Programmer
13+ years · Phase I–III · FDA, EMA & PMDA
About Vinilytics

Precision programming,
personally accountable.

Jagadeesh Thandlam is a Certified Advanced SAS Programmer with over 13 years of experience across the full clinical programming spectrum — SDTM and ADaM development, TLF production, define.xml, CDISC Reviewer’s Guides, and regulatory submission packages delivered to FDA, EMA, and PMDA.

He has held senior and principal programming roles at Quanticate, Quintiles (IQVIA), PAREXEL, ICON, and TFS Health Science — working across pharma, biotech, and medical device programmes spanning Phase I to III across more than twelve therapeutic areas.

Vinilytics was founded to bring that cross-industry principal-level depth to sponsors with direct, accountable engagement on every programme — before it leaves our hands. Every define.xml, programming specification, and Reviewer’s Guide is built to the documentation standard agencies expect at submission and through inspection.

Therapeutic Areas
Gene TherapyOncology HaematologyImmunology CardiovascularRespiratory OphthalmologyRenal EndocrinologyNeurology Medical DevicesInfectious Disease Dermatology
Why Vinilytics

Built for inspection
from the inside.

The gap between a submission that clears review and one that generates queries often traces back to decisions made during CRF review and SDTM mapping — assumptions buried in derivation logic, metadata gaps in define.xml, ADaM structures that don’t align with the SAP. We prevent those problems upstream.

Inspection-ready by design — not after

Regulatory documentation, programming specs, and audit trail built into the workflow from the start. No retroactive compliance packaging at the end of a programme.

Principal-level review on every deliverable

Every dataset, TLF, and submission package reviewed at principal level before it leaves our hands. Your programme is never delegated once the SOW is signed.

CDISC precision from CRF review through lock

Mapping specifications built from CRF review — fewer SDTM assumptions, cleaner derivations, and ADaM datasets that don’t need structural remediation before lock.

FDA, EMA, and PMDA — all three agencies

Multi-regional submission experience with eCTD packages adapted to each agency’s reviewer standards from programme start, not converted from an FDA template at the end.

CDISC & Regulatory Standards
CDISC SDTM 3.4Data Standard
ADaM 1.3Analysis Data
define.xml 2.1Submission
eCTD Module 5Regulatory
ICH E9(R1)Estimands
Pinnacle 21Validation
SAS 9.4Programming
21 CFR Part 11Compliance
Regulatory Agencies
FDACDER / CBER
EMAEuropean Medicines Agency
PMDAJapan
Engagement Models

Full-service biometrics partner · Functional Service Provider (FSP) · Standalone SAP or programming consultation — structured around your programme, not a fixed delivery model.

Start a Conversation

Ready to scope
your programme?

Tell us about your study — phase, therapeutic area, current biometrics gaps, and timeline. Jagadeesh will respond personally with an honest assessment of fit and a proposed engagement structure.

hello@vinilytics.com
Gallery Building, Hubflow, 65–69 Dublin Rd,
Belfast, BT2 7HG, United Kingdom
Response within one business day
NDAs available on request before programme discussion
Confidential engagement — NDA on request before any programme discussion begins
No delegation — direct response from Jagadeesh Thandlam, Founder
No sales calls before we understand your programme.
Project Intake — Scope Your Engagement
Reviewed personally by Jagadeesh · Response within 1 business day
Vinilytics Ltd · hello@vinilytics.com
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Vinilytics · CDISC & Biometrics Expert

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Pinnacle 21
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