About Us

Clinical Data Experts. SAS Programmers. Regulatory Specialists.

Fragrance Trails India Private Limited is built on deep domain expertise in clinical trial data analysis, CDISC programming, and regulatory submissions — delivered by a team with decades of combined experience in pharmaceutical and biotech research.

CDMSDTMADaMTLFsSAPsClinical Data Delivery Pipeline

Our Mission

Precision Data. Trusted Results.

We exist to give pharmaceutical sponsors, CROs, and biotech companies the clinical data expertise they need to bring safe, effective treatments to patients faster. Every dataset we program, every TLF we produce, and every submission package we prepare is built on a foundation of scientific rigor, regulatory knowledge, and an uncompromising commitment to data integrity.

Core Expertise

What We Know Best

SAS Programming

Advanced SAS programming for SDTM, ADaM, and TLF production. Our programmers are proficient in Base SAS, SAS/STAT, SAS/GRAPH, PROC SQL, macro programming, and ODS for clinical reporting.

CDISC Standards

Deep expertise in CDISC SDTM, ADaM, CDASH, and controlled terminology. We stay current with the latest SDTMIG and ADaMIG versions and FDA/EMA submission requirements.

Regulatory Knowledge

Hands-on experience with FDA, EMA, PMDA, and CDSCO submission requirements. We understand what reviewers look for and build datasets and documentation accordingly.

Statistical Analysis

Biostatistics expertise spanning Phase I–IV trials, adaptive designs, survival analysis, mixed models, and non-inferiority studies — aligned with global regulatory frameworks.

Our Team

The Expertise Behind Every Deliverable

Our team combines years of hands-on clinical programming experience with deep knowledge of CDISC standards, SAS, and global regulatory requirements.

Lead SAS Programmer

Senior Clinical Programmer

10+ yearsSDTM & ADaM Programming

Extensive experience in SDTM and ADaM dataset programming for Phase I–IV trials across oncology, cardiology, and rare disease therapeutic areas. Proficient in Base SAS, PROC SQL, SAS macros, and Pinnacle 21 validation. Has delivered submission-ready datasets for multiple NDA and MAA filings.

Key Skills

Base SASSAS MacrosSDTM ProgrammingADaM ProgrammingPinnacle 21define.xmlSDRG/ADRG

Biostatistician

Statistical Analyst

8+ yearsSAPs & Statistical Analysis

Specializes in developing regulatory-compliant Statistical Analysis Plans and performing primary and secondary endpoint analyses for confirmatory trials. Experienced in survival analysis, mixed models for repeated measures (MMRM), logistic regression, and non-inferiority testing.

Key Skills

SAS/STATMMRMSurvival AnalysisSAP DevelopmentAdaptive DesignsR Programming

TLF Programmer

Clinical Reporting Specialist

7+ yearsTables, Listings & Figures

Expert in producing all clinical study report outputs — safety tables, efficacy summaries, patient listings, and statistical figures — using SAS ODS, PROC REPORT, and PROC SGPLOT. Experienced in double-programming QC and sponsor shell implementation across multiple therapeutic areas.

Key Skills

SAS ODSPROC REPORTPROC SGPLOTTLF ProgrammingDouble-Programming QCCSR Support

CDM Specialist

Clinical Data Manager

9+ yearsData Management & CRF Design

Experienced in end-to-end clinical data management including CRF design, EDC database build, edit check programming, query management, and database lock. Proficient in Medidata Rave, Oracle InForm, and REDCap. Deep knowledge of CDISC CDASH, 21 CFR Part 11, and Good Clinical Practice.

Key Skills

Medidata RaveOracle InFormREDCapCDASHEdit Check Programming21 CFR Part 11Good Clinical Practice

Standards & Compliance

Built on Global Regulatory Frameworks

CDISC SDTM

Study Data Tabulation Model

CDISC ADaM

Analysis Data Model

CDISC CDASH

Clinical Data Acquisition Standards Harmonization

21 CFR Part 11

Electronic Records & Signatures

FDA eSubmission

Technical Conformance Guide

EMA Standards

XEVMPD & EMA Data Standards

Work With Our Team

Tell us about your clinical program and we will match the right expertise to your needs.

Fragrance Trails India Private Limited