Our Services

Full-spectrum CRO services. Built around your study.

From first-in-human to post-marketing, CRONCOX delivers integrated clinical research services with a sharp specialism in clinical data management and biometrics.

Service 01

Clinical Data Management

End-to-end ownership of your study database — from protocol-aligned CRF design to fully locked, CDISC-compliant data packages ready for analysis and submission.

Detailed Capabilities →
✓CRF & eCRF design (CDASH-aligned)
✓EDC build (Rave, InForm, Veeva Vault, OpenClinica)
✓Edit check programming & UAT
✓DMP authoring & maintenance
✓Query management (24-hr SLA)
✓Medical coding (MedDRA, WHODrug)
✓SAE reconciliation
✓Database lock & transfer
✓Statistical Analysis Plan (SAP) authoring
✓SDTM dataset generation (CDISC v1.8+)
✓ADaM analysis datasets (v1.3)
✓Tables, Listings, Figures (TLF) production
✓SAS, R, and Python programming
✓define.xml & ADRG generation
✓Sample size & power calculations
✓Interim analyses & DMC support
Service 02

Biostatistics & Programming

SAS, R, and Python-based statistical programming delivered against CDISC standards. From sample size justification through submission-ready TLFs, our biostatistics team integrates with your protocol from day one.

Service 03

Clinical Operations

Phase I through IV trial execution with rigor and pace. Our clinical operations team brings deep ICH-GCP expertise across feasibility, site selection, monitoring, and project management.

✓Protocol feasibility & site selection
✓Site initiation & monitoring (SIV, MV, COV)
✓Risk-based monitoring (RBM)
✓Project management & vendor oversight
✓eTMF management
✓Investigator meetings & training
✓Patient recruitment strategy
✓CRO-sponsor co-monitoring
✓Clinical protocol authoring
✓Investigator's Brochure (IB)
✓Informed Consent Forms (ICF)
✓Clinical Study Reports (CSR – ICH E3)
✓FDA IND, EMA CTA, CDSCO submissions
✓Common Technical Document (CTD)
✓Manuscript & abstract preparation
✓Regulatory response strategy
Service 04

Regulatory & Medical Writing

From protocol concept to submission dossier — our medical writers and regulatory professionals craft documents that withstand the toughest agency scrutiny across FDA, EMA, CDSCO, and PMDA.

Service 05

Pharmacovigilance & Safety

Drug safety is a continuous obligation — and a regulatory minefield. Our pharmacovigilance team manages case processing, signal detection, and aggregate reporting with global compliance.

✓ICSR / SAE case processing
✓MedDRA & WHODrug coding
✓Argus / ArisGlobal safety database
✓PSUR / PBRER preparation
✓DSUR authoring
✓Signal detection & risk management
✓E2B (R3) electronic reporting
✓Literature surveillance
✓Observational study design
✓Patient registries
✓EHR & claims data analysis
✓PRO / ePRO instrument design
✓Health economics outcomes research
✓Comparative effectiveness studies
✓Burden of illness studies
✓Post-marketing surveillance
Service 06

Real-World Evidence

Beyond the clinical trial — we help sponsors generate evidence from the real world. Observational studies, patient registries, EHR analytics, and PRO instruments calibrated for regulatory acceptance.

Have a study in mind? Let's scope it together.

Request a Proposal →