Clinical Research & Data Analysis
Precision in Clinical Data. Clarity in Every Analysis.
Fragrance Trails India Private Limited delivers expert clinical trial data analysis, biostatistics, and data management services to pharmaceutical companies, CROs, and biotech firms worldwide.
100+
Trials Supported
20+
Years Combined Expertise
Global
Regulatory Standards
About Us
Fragrance Trails India Private Limited provides end-to-end data science and statistical services for the pharmaceutical and healthcare research industry, supporting clinical trials from protocol design through regulatory submission.
Our Services
End-to-End Clinical Data Solutions
From study design to regulatory submission, we provide the statistical and data management expertise your clinical program demands.
CRF Annotation
Systematic annotation of Case Report Forms (CRFs) with CDISC CDASH and SDTM variable mappings. We produce annotated CRFs that serve as the authoritative bridge between data collection instruments and submission-ready datasets, ensuring traceability from source data to final analysis.
SDTM Specifications & Dataset Programming
End-to-end SDTM specification development and dataset programming aligned with CDISC SDTM Implementation Guides (SDTMIG). We author detailed mapping specifications, program all SDTM domains (DM, AE, CM, EX, LB, VS, and more), and produce submission-ready datasets with compliant define.xml and reviewer's guides.
ADaM Dataset Programming
Development of Analysis Data Model (ADaM) datasets — including ADSL, ADAE, ADCM, ADLB, ADTTE, and custom analysis datasets — per CDISC ADaM Implementation Guides. We author ADaM specifications, program datasets in SAS or R, and validate outputs to support all primary and secondary efficacy and safety analyses.
Tables, Listings & Figures (TLFs)
Production of all clinical study report outputs — summary tables, patient data listings, and statistical figures — programmed to sponsor shells and regulatory standards. Our TLF programming covers efficacy, safety, PK/PD, and subgroup analyses, with full QC and validation documentation.
Statistical Analysis Plans (SAPs)
Regulatory-compliant Statistical Analysis Plans covering estimands, primary and secondary endpoints, sensitivity analyses, handling of missing data, and randomization methodology. We develop SAPs for Phase I–IV trials, adaptive designs, and complex innovative designs.
Clinical Data Management
Full-service CDM including CRF design, database build, edit check programming, data validation, query management, and database lock. All processes are aligned with CDISC CDASH standards, 21 CFR Part 11, and Good Clinical Practice requirements.
Safety Reporting & Pharmacovigilance
Adverse event coding (MedDRA), CIOMS and SAE narratives, safety data tabulations, and signal detection support. We help sponsors meet global pharmacovigilance requirements for IND safety reports, DSURs, and periodic safety update reports.
Regulatory Submissions Support
Preparation of complete submission packages for NDA, BLA, MAA, and CTD Module 5 — including SDTM/ADaM datasets, define.xml, ADRG, SDRG, and reviewer's guides — aligned with FDA, EMA, PMDA, and CDSCO requirements.
Regulatory Expertise
Deep knowledge of FDA, EMA, and PMDA guidelines ensures your data meets the highest global standards.
Data Integrity
Rigorous quality control processes and audit-ready documentation at every stage of the data lifecycle.
End-to-End Support
From protocol design and SAP development through final submission, we are your single partner for clinical data excellence.
Ready to Advance Your Clinical Program?
Partner with a team that understands the precision and regulatory rigor your clinical trials demand.