Every discipline your trial needs, under one roof
From first site activated to last safety report filed — the entire clinical research lifecycle, covered end to end.
Think Quality, Think Excelion Research
Your Strategic Quality Partner
Seven divisions, one click away
Division 01
ExcelSite
Site Management
Sites that perform. Trials that deliver.
Site management organization (SMO) support that keeps trials moving — data-led patient recruitment, standardized site infrastructure, investigator training, and audit-ready documentation across a network of experienced research sites.
- Patient Recruitment
- Site Infrastructure
- Investigator Training
- eISF / ISF Documentation
40% Faster
Site Enrollment Speed
Division 02
ExcelSure
Independent GCP Audit
Quality proven, not presumed.
Independent GCP audits, mock inspections, CAPA management, and risk-based quality oversight that surface compliance gaps before they become regulatory findings.
- GCP & Vendor Audits
- Mock Inspections
- CAPA Management
- RBQM
- Quality Consulting
60% Drop
In Protocol Deviations
Division 03
Excel360
Clinical Trial Monitoring
Every site. Every data point. In view.
Hybrid on-site and centralized risk-based monitoring from site initiation to close-out — strengthening protocol compliance, subject safety, and continuous inspection readiness.
- SQV, SIV, SMV, SCV
- Centralized RBM
- SDV / SDR
- KRI Analytics
- Compliance Oversite
60% Reduction
In Monitoring Findings
Division 04
ExcelRegX
Regulatory Affairs
From strategy to submission, without friction.
Strategic regulatory guidance from pre-IND engagement through marketing authorization — eCTD submissions, agency liaison, and lifecycle compliance across FDA, EMA, and CDSCO.
- IND / NDA / ANDA (eCTD)
- Agency Liaison
- Regulatory Strategy
- Lifecycle Management
95% First-Cycle
Acceptance Performance
Division 05
ExcelPV
Pharmacovigilance
Safety engineered. Confidence delivered.
End-to-end pharmacovigilance across the product lifecycle — ICSR management, aggregate safety reporting, signal management, PSMF, and inspection-ready PV quality systems.
- ICSR Management
- PSUR / PBRER / DSUR
- Signal Management
- PSMF
- Literature Surveillance
End-to-End
Lifecycle Safety Coverage
Division 06
ExcelStat
Biostatistics
Evidence, engineered with statistical rigor.
Biostatistics and statistical programming across the study lifecycle — study design, statistical analysis plans, CDISC-compliant datasets, and submission-ready statistical deliverables.
- Study Design & Sample Size
- SAP Development
- CDISC SDTM / ADaM
- TLF Programming
- DSMB Support
CDISC
Submission-Ready Standards
Division 07
ExcelCSV
Computer System Validation
Trusted systems. Defensible data.
GAMP 5 risk-based computer system validation for GxP systems — from validation planning and IQ/OQ/PQ execution through data integrity assessment and periodic review.
- GAMP 5 Validation
- 21 CFR Part 11 / Annex 11
- IQ / OQ / PQ
- Data Integrity (ALCOA+)
GAMP 5
Risk-Based Validation
One partner across the entire clinical lifecycle
Wherever your program stands today, a division is already in position — with ExcelSure and ExcelCSV active at every phase.
- 01
Study Design & Start-Up
Protocol strategy, site activation & regulatory groundwork
- 02
Trial Conduct
Enrollment, monitoring & clinical safety oversight
- 03
Analysis & Submission
Statistical evidence & marketing authorization
- 04
Post-Marketing
Surveillance, safety reporting & lifecycle compliance
In clinical research, precision isn't just a metric — it's a moral imperative. Our commitment to precision guides every step of our scientific process.
Mr. Niraj Thakkar
Co-founder & Director, Excelion Research