Our Services

Comprehensive Clinical Data Services

From CRF annotation and SDTM mapping through ADaM programming, TLF production, and regulatory submission — we deliver every layer of clinical trial data expertise under one roof.

The Full Data Lifecycle, Covered

Fragrance Trails India provides end-to-end clinical data services for pharmaceutical sponsors, CROs, and biotech companies. Our team brings deep expertise in CDISC standards, SAS/R programming, and global regulatory requirements — ensuring your clinical data is accurate, submission-ready, and audit-proof at every stage.

CRF Annotation

Bridging Data Collection to CDISC Standards

Annotated Case Report Forms (aCRFs) are the foundational traceability document connecting your data collection instruments to submission-ready SDTM datasets. Our team produces fully annotated CRFs that map every data point to its corresponding CDISC CDASH and SDTM variable, domain, and codelist.

CDASH-to-SDTM variable mapping for all CRF pages
Annotation of paper and electronic CRFs (EDC systems)
Codelist and controlled terminology alignment (CDISC CT)
Traceability matrices linking CRF fields to SDTM variables
Reviewer-ready aCRF PDF packages for regulatory submissions
Compliance with FDA and EMA aCRF submission requirements

SDTM Specifications & Dataset Programming

Submission-Ready SDTM Datasets, Built Right

Study Data Tabulation Model (SDTM) datasets are the cornerstone of every regulatory submission. We develop detailed SDTM specifications and program all required domains to the latest CDISC SDTMIG, producing datasets that pass FDA and EMA validation checks first time.

SDTM mapping specifications for all domains (DM, AE, CM, EX, LB, VS, MH, DS, and more)
Dataset programming in SAS (PROC SQL, DATA step) and R
SUPPQUAL and RELREC relationship datasets
define.xml (Define-XML 2.0/2.1) and Study Data Reviewer's Guide (SDRG)
Pinnacle 21 / OpenCDISC validation and issue resolution
FDA eSubmission and EMA XEVMPD compliance checks

ADaM Dataset Programming

Analysis-Ready Datasets for Every Endpoint

Analysis Data Model (ADaM) datasets are the direct input to all statistical analyses and TLF programs. We develop ADaM specifications and program datasets that support primary, secondary, and exploratory endpoints — with full traceability back to SDTM source data.

ADSL (Subject-Level Analysis Dataset) for all demographic and baseline variables
ADAE (Adverse Events) with treatment-emergent flag derivations
ADCM (Concomitant Medications) with standardized coding
ADLB (Laboratory) with CTCAE grading and shift analyses
ADTTE (Time-to-Event) for survival and event-rate analyses
Custom efficacy and PK/PD analysis datasets
Analysis Data Reviewer's Guide (ADRG) and define.xml

Tables, Listings & Figures (TLFs)

Precise, Validated Clinical Study Report Outputs

TLFs are the visible output of every clinical trial — the evidence that regulators, medical reviewers, and safety boards rely on. Our TLF programming team delivers all summary tables, patient data listings, and statistical figures to sponsor shells and regulatory standards, with rigorous double-programming QC.

Demographic and baseline characteristic tables
Efficacy summary and responder analysis tables
Adverse event, SAE, and CIOMS safety tables
Laboratory, vital signs, and ECG shift and change-from-baseline tables
Kaplan-Meier survival curves and forest plots
Patient data listings for all safety and efficacy parameters
Subgroup and sensitivity analysis outputs
Full double-programming QC with discrepancy resolution

Statistical Analysis Plans (SAPs)

Rigorous Statistical Planning from Protocol to Report

A well-constructed SAP is the statistical backbone of a clinical trial. We develop regulatory-compliant SAPs that pre-specify every analysis decision — estimands, endpoints, handling of missing data, sensitivity analyses — eliminating ambiguity and protecting the integrity of your results.

Estimand framework per regulatory addendum
Primary, secondary, and exploratory endpoint specifications
Randomization and stratification methodology
Handling of missing data and intercurrent events
Sensitivity and supplementary analyses
Multiplicity adjustments and alpha-spending strategies
Adaptive design statistical considerations
SAP amendments and version control

Clinical Data Management

Data Integrity from First Entry to Database Lock

Reliable clinical data starts with rigorous data management. We provide full-service CDM — from CRF design and database build through edit check programming, query management, and database lock — all aligned with CDISC CDASH, 21 CFR Part 11, and Good Clinical Practice.

CRF design and eCRF build (Medidata Rave, Oracle InForm, REDCap)
Data Management Plan (DMP) authoring
Edit check and validation rule programming
Data query management and resolution tracking
External data reconciliation (lab, ECG, PK, ePRO)
Medical coding (MedDRA, WHO Drug)
Database lock and audit trail review
21 CFR Part 11 and GDPR compliance

Safety Reporting & Pharmacovigilance

Protecting Patients Through Precise Safety Data

Safety data accuracy is non-negotiable. We provide comprehensive adverse event analysis, MedDRA coding, safety narrative writing, and signal detection support — helping sponsors meet global pharmacovigilance requirements on time and to the highest quality standard.

Adverse event and SAE data tabulations
MedDRA coding and SMQ analysis
CIOMS I and SAE narrative writing
DSUR and PSUR safety data preparation
IND safety report support (15-day and annual reports)
Safety signal detection and aggregate analysis
Benefit-risk assessment data support
Regulatory authority query response support

Regulatory Submissions Support

Submission-Ready Packages for Global Agencies

Regulatory submissions demand flawless data packages. We prepare complete submission-ready data and documentation for NDA, BLA, MAA, and CTD Module 5 filings — covering SDTM/ADaM datasets, define.xml, reviewer's guides, and validation reports — aligned with FDA, EMA, PMDA, and CDSCO requirements.

NDA, BLA, and MAA data package preparation
CTD Module 5 clinical study report data support
define.xml (Define-XML 2.0/2.1) authoring
Study Data Reviewer's Guide (SDRG) and Analysis Data Reviewer's Guide (ADRG)
Pinnacle 21 validation and FDA Technical Rejection Criteria (TRC) compliance
FDA eSubmission gateway and EMA XEVMPD preparation
Regulatory authority data query response
CDSCO and PMDA submission alignment

Ready to Advance Your Clinical Program?

Tell us about your study and we will scope a tailored data solution.

Get in Touch