Eupraxia Consulting
End-to-End Data Solutions for Regulatory Submission Excellence
Your trusted global CRO partner delivering FDA-aligned biostatistics, CDISC programming, and regulatory submission services across USA, Europe, India, Australia, and Africa.
FDA-Aligned
100% Regulatory Compliance
CDISC Standards
SDTM, ADaM, SEND
End-to-End
Preclinical to Submission
Global Reach
USA, EU, PMDA, TGA, Health Canada
Your Trusted Partner in Clinical Data Excellence
We deliver comprehensive, FDA-aligned data solutions that accelerate your regulatory journey from preclinical studies to market approval.
Eupraxia Consulting specializes in providing end-to-end data solutions for the clinical trial industry with global reach spanning USA, Europe, India, Australia, and Africa. Our team of experienced biostatisticians, statistical programmers, and data management experts ensures your regulatory submissions meet the highest standards of quality and compliance across ICH-GCP, FDA, EMA, PMDA, and HTA requirements.
Industries We Serve
Biotech
Pharmaceutical
Radio Pharma
Vaccine Development
Oncology
Respiratory
Cardiovascular
CNS
Our Core Services
Comprehensive data solutions across clinical development and CMC manufacturing excellence
Biostatistics Portfolio
Global regulatory expertise spanning FDA, EMA, PMDA, NICE, CADTH, and HTA agencies. Adaptive designs, Bayesian methods, and RFI-ready deliverables.
Learn MoreStatistical Programming
CDISC standards expertise: SDTM, ADaM, Define.xml, complete QC/validation aligned to FDA eSub requirements.
Learn MoreClinical Data Management
EDC system management, eCRF design, data validation, medical coding across all clinical trial phases.
Learn MorePreclinical & SEND
SEND dataset creation for toxicity, safety pharmacology, TK, DART, carcinogenicity, and specialized studies.
Learn MoreRegulatory Affairs & QA
Medical device support: Technical files, CE marking, 510(K) filing, ISO 13485 consultation.
Learn MoreStaffing Solutions
Specialized talent placement for biostatisticians, programmers, data managers, and regulatory specialists.
Learn MoreBioequivalence Studies
ABE and PBE studies per USFDA/EMEA guidelines, including particle size distribution analysis.
Learn MoreCMC Statistics
Chemistry, Manufacturing, and Controls statistical expertise: method validation, stability analysis, process validation, DoE/QbD, and Module 3 deliverables.
Learn MoreWhy Choose Eupraxia Consulting
FDA Regulatory Alignment
All our services comply with FDA guidance documents and regulatory requirements
CDISC Expertise
Deep expertise in SDTM, ADaM, SEND standards with highly experienced professionals
End-to-End Coverage
From preclinical studies through market submission and beyond
Global Standards
USFDA, EMEA, PMDA, NICE, IQWiG, HAS, PBAC, CADTH, and international HTA expertise
Our Services
Comprehensive, FDA-aligned data solutions across the entire clinical development lifecycle
Biostatistics: Driving Confidence in Every Phase
Effective clinical development begins with robust statistical planning. We provide a seamless framework spanning the full clinical lifecycle—from first-in-human Phase I studies to multinational Phase IV post-marketing programs. With unwavering ICH-GCP compliance, patient-first ethics, and adaptive methodologies, we empower sponsors to move confidently from bench to bedside.
Comprehensive overview of our biostatistical services, methodologies, and global regulatory expertise
Global Reach & Regulatory Expertise
Our global expertise extends across the USA, Europe, India, Australia, and Africa—delivering harmonized solutions that optimize timelines, elevate data integrity, and ensure regulatory submission readiness worldwide.
Our biostatistical consultancy is embedded at every stage of development, ensuring trials are designed, powered, and executed with scientific precision. We collaborate with sponsors to define clinically meaningful, statistically defensible endpoints while minimizing bias and maximizing efficiency.
Protocol Design & Sample Size Estimation
Clinically meaningful endpoints, bias-minimizing protocols, simulation-validated sample sizes, and robust randomization strategies for all trial phases
Statistical Analysis Plans (SAPs)
SAP development, review, and execution with ICH E9(R1) estimand framework integration and transparent handling of intercurrent events
TLF Development & Mock Shells
Preparation of TLF mock shells and regulatory-ready outputs aligned with ICH E3 standards
Interim & Final Analyses
Safety and efficacy analyses with group sequential designs (O'Brien-Fleming, Pocock boundaries), multiplicity adjustments, and Type I error control
DSMB Support & Safety Monitoring
Independent DSMB reporting, blinded/unblinded summaries, safety endpoint monitoring, and firewall protocols to protect trial integrity
FDA Briefing Book Preparation
Critical statistical inputs for draft protocols, briefing books, and FDA meetings (Type A, B, C) including sponsor training
Regulatory Deliverables & CSR Review
CDISC-compliant SDTM/ADaM datasets, TLF generation, Integrated Summaries of Safety (ISS) and Efficacy (ISE), statistical CSR review, and dossier contributions
Post-Hoc & Exploratory Analyses
Subgroup analyses, survival modeling, repeated measures, longitudinal modeling, PK/PD evaluation, and regulatory query responses (FDA RFIs)
Advanced & Adaptive Methodologies
Clinical development demands flexibility. Our statisticians design adaptive, model-based strategies that accelerate timelines while preserving scientific integrity.
Adaptive Trial Designs
Real-time interim decision-making with dose selection, arm dropping, enrichment strategies, and seamless Phase I/II and II/III transitions
Sample Size Re-Estimation (SSR)
Mid-trial recalibration based on variance, event rate, or effect size estimates—blinded or unblinded—while maintaining Type I error control
Bayesian Methods
Bayesian frameworks for robust inference under uncertainty, prior elicitation, and posterior probability assessments for complex oncology and rare disease trials
Model-Based Drug Development
Advanced PK/PD analytics, exposure-response modeling, dose optimization, and seamless integration of pharmacometric insights
Meta-Analyses & Network Meta-Analyses (NMA)
Indirect treatment comparisons, anchored analyses, and synthesis of evidence for regulatory and HTA submissions
Anticipating FDA Requests for Information (RFIs)
Our team has extensive experience preparing rapid, scientifically sound responses to FDA RFIs across all trial phases:
Phase I (FIH, SAD/MAD, PK/PD)
- PK/PD model clarifications and exposure-response relationships
- Dose proportionality and bioequivalence analyses
- First-in-human dose escalation justifications
Phase II (Proof-of-Concept)
- Dose selection justifications (efficacy/safety balance)
- Subgroup and sensitivity analyses
- Multiplicity adjustments across co-primary/secondary endpoints
Phase III (Pivotal/NDA/BLA)
- Missing data and intercurrent events (ICH E9[R1] estimands)
- Sample size and power justifications
- Randomization and blinding methodology
- Treatment-switching adjustments (RPSFTM, IPCW)
Phase IV (Post-Marketing/RWE)
- Post-hoc safety signal analyses
- Pharmacovigilance signal detection methods
- Real-world evidence (RWE) and HEOR analyses
Global Statistical Submission Expertise
Deep knowledge of country-specific regulatory and HTA requirements ensures submissions are compliant, persuasive, and market-ready across global jurisdictions:
Germany (AMNOG / IQWiG)
Module 4 dossiers with patient-relevant outcomes, time-to-event methods, validated responder analyses (≥15%), and anchored indirect comparisons
France (HAS)
SMR/ASMR evaluations emphasizing clinically meaningful benefit through head-to-head data or validated indirect evidence
United Kingdom (NICE)
Advanced survival modeling, treatment-switching adjustments, and extrapolation consistent with NICE DSU guidelines
European Union (EMA / EU-HTA)
ICH E9(R1) estimands, sensitivity analyses, and indirect/NMA evidence for joint clinical assessments
United States (FDA)
Multiplicity control, adaptive design simulations, pre-specification of endpoints, Type I error control, and transparent reporting
Japan (PMDA)
ICH E9(R1) estimand principles with sensitivity analyses and proactive consultation practices
Australia (PBAC)
Survival extrapolation, surrogate validation, and transparent uncertainty management for reimbursement dossiers
Canada (CADTH)
Non-inferiority margins, intercurrent event strategies, and real-world evidence integration for structured submissions
Why Our Biostatistics Services Excel
By embedding jurisdiction-specific insights into every deliverable, we support sponsors in achieving regulatory compliance and market access success across USA, Europe, Asia-Pacific, and emerging markets—accelerating your path from Phase I FIH studies to global commercialization.
Statistical Programming (CDISC Standards)
Expert statistical programming services utilizing CDISC standards to ensure your data submissions meet FDA eSub requirements with complete traceability and validation.
Comprehensive overview of our CDISC programming capabilities, QC processes, and eSub deliverables
SDTM Development
Study Data Tabulation Model datasets following CDISC SDTM Implementation Guide
ADaM Dataset Programming
Analysis Data Model datasets (ADSL, BDS, OCCDS, Other) for regulatory submissions
Define.xml & Metadata
Complete metadata documentation including Define.xml v2.1 specification
Reviewer's Guides
Study Data Reviewer's Guide (SDRG) and Analysis Data Reviewer's Guide (ADRG)
Full QC/Validation
Independent QC processes aligned to FDA validation requirements with complete audit trails
TLF Production
Tables, Listings, and Figures production with full validation and annotation
Clinical Data Management
Comprehensive clinical data management services ensuring data quality, integrity, and compliance across all phases of clinical trials using industry-leading EDC systems.
Detailed overview of our EDC expertise, data management processes, and medical coding services
EDC System Setup & Management
Expert support for Medidata Rave, Oracle Clinical, REDCap, Veeva Vault, and other EDC platforms
eCRF Design & Build
User-friendly electronic Case Report Form design with built-in data validation
Data Validation & Cleaning
Comprehensive edit checks, query management, and data cleaning processes
Medical Coding
MedDRA, WHODrug, and other standardized medical coding dictionaries
Database Lock & Data Transfer
Controlled database lock procedures and CDISC-compliant data transfers
All Clinical Trial Phases
Phase I through Phase IV trial support with regulatory compliance
Preclinical & Nonclinical SEND Services
Specialized expertise in SEND (Standard for Exchange of Nonclinical Data) dataset creation and biostatistical analysis for preclinical and nonclinical studies following FDA and OECD guidelines.
Complete overview of our SEND dataset expertise, nonclinical study support, and FDA/OECD guideline compliance
SEND Dataset Creation
Complete SEND 3.0/3.1 dataset generation compliant with FDA eSub requirements
Acute Toxicity Studies
Single-dose toxicity study data conversion and analysis
Repeat Dose Toxicity Studies
Sub-acute, sub-chronic, and chronic toxicity studies (28-day, 90-day, 1-year)
Safety Pharmacology Studies
CNS, cardiovascular, respiratory safety pharmacology assessments
Toxicokinetic (TK) Studies
TK data analysis and SEND conversion with exposure-response assessments
DART Studies
Developmental and Reproductive Toxicity study data management and analysis
Carcinogenicity Studies
Long-term oncogenicity study data conversion and statistical analysis
Specialized Organ System Studies
Neurotoxicity, cardiotoxicity, and respiratory toxicity assessments
Biostatistical Analysis
Per FDA guidance and OECD guidelines for nonclinical studies
Regulatory Affairs & QA Consultation (Medical Devices)
Comprehensive regulatory affairs and quality assurance support for medical device companies navigating FDA, EU MDR, and international regulatory pathways.
Comprehensive overview of our medical device regulatory support, QMS consultation, and international compliance services
Technical File Preparation
Complete technical documentation packages for regulatory submissions
CE Marking (EU MDR/IVDR)
European regulatory compliance support including notified body interactions
510(K) Filing Preparation
FDA 510(K) premarket notification preparation and submission support
ISO 13485 Consultation
Quality Management System implementation and certification support
Risk Management (ISO 14971)
Medical device risk assessment and management documentation
Post-Market Surveillance
Post-market clinical follow-up (PMCF) and vigilance reporting
QMS Development
Quality Management System design, implementation, and maintenance
CMC Statistics: Manufacturing & Analytical Excellence
Specialized Chemistry, Manufacturing, and Controls (CMC) statistical expertise ensuring your manufacturing and analytical data withstand regulatory scrutiny. CMC statistical expectations differ significantly from clinical biostatistics—regulators evaluate specification justification, stability modeling robustness, equivalence margins, and control strategy defensibility.
Detailed overview of our CMC statistical services, methodologies, and Module 3 deliverables
Why CMC Statistics Matters
Our expertise reduces review cycles, deficiency letters, and approval delays by ensuring transparent handling of variability, robust statistical assumptions, and regulatory-aligned methodologies for Module 3 submissions.
Analytical Method Validation & Lifecycle Management
Precision, accuracy, linearity, and robustness evaluation. Variance component analysis, ANOVA models, measurement uncertainty estimation, method equivalence & transfer studies. ICH Q2/Q14 compliance support.
Specification Setting & Justification
Data-driven release and shelf-life specifications using tolerance interval approaches. Process capability (Cp, Cpk, Ppk) evaluation, clinical-to-commercial bridging, statistical rationale for impurity limits, and risk-based acceptance criteria design.
Stability Analysis & Expiry Dating
Shelf-life estimation using regression modeling, poolability and batch comparison testing, degradation kinetics and Arrhenius modeling, trend detection, OOT evaluation. ICH Q1 submission support.
Process Validation & Continued Process Verification (CPV)
Stage 1–3 statistical support, PPQ batch evaluation, control chart strategy design (Shewhart, EWMA, CUSUM), process capability studies, OOS/OOT investigations, and Annual Product Review trending analytics.
Comparability & Post-Approval Change Support
Site transfers and scale-up assessments, equipment or raw material change justification, equivalence testing (TOST frameworks), multivariate comparability modeling, and statistical bridging for regulatory supplements.
Dissolution & In-Vitro Performance Modeling
f2 similarity assessment with bootstrap confidence intervals, variability modeling, model-dependent dissolution approaches, and statistical justification of dissolution specifications.
Design of Experiments (DoE) & Quality by Design (QbD)
Screening and optimization studies, response surface modeling, design space establishment, interaction and robustness evaluation. Statistical defense of control strategies aligned with ICH Q8–Q12.
Multivariate Analytics & PAT Support
PCA/PLS model development, real-time release testing strategy, multivariate process monitoring, model validation, and lifecycle governance for Process Analytical Technology.
Comprehensive documentation for Module 3 submissions and regulatory queries:
Statistical Analysis Reports
Module 3 submissions with full traceability
Specification Justification
Data-driven acceptance criteria rationale
Stability Modeling Reports
Shelf-life estimation with statistical rigor
Process Capability Dossiers
Cp, Cpk, Ppk evaluation documentation
Equivalence Reports
Comparability and bridging analyses
Regulatory Query Responses
Rapid, scientifically sound RFI answers
Regulatory Scrutiny-Ready CMC Statistics
Our CMC statistical expertise ensures regulators find adequate specification justification, robust stability modeling, appropriate equivalence margins, defensible control strategies, aligned process capability, and transparent variability handling—accelerating approval timelines and minimizing deficiency letters.
Staffing Solutions (USA)
Specialized talent acquisition and staffing services connecting leading biotech, pharma, and medical device companies with highly qualified professionals.
Overview of our specialized staffing services and talent placement capabilities for biotech, pharma, and CRO sectors
Biostatisticians
PhD and Master's level biostatisticians with clinical trial expertise
Statistical Programmers
SAS programmers with CDISC standards expertise (SDTM, ADaM, SEND)
Clinical Data Managers
EDC-experienced data managers and data coordinators
Regulatory Affairs Specialists
FDA and international regulatory submission experts
Flexible Engagement Models
Contract, contract-to-hire, and permanent placement options
Industry Focus
Specialized placement for CRO, pharmaceutical, biotech, and medical device sectors
Bioequivalence Studies
Expert bioequivalence statistical analysis services following USFDA and EMEA regulatory guidelines for generic drug development and approval.
Detailed overview of our bioequivalence study expertise for USFDA and EMEA generic drug submissions
Average Bioequivalence (ABE)
Standard 2x2 crossover and higher-order designs per FDA guidance
Population Bioequivalence (PBE)
Complex PBE analyses for highly variable drugs and products
Particle Size Distribution Studies
PSD-based bioequivalence for locally acting products (OIP, nasal, topical)
BE Statistical Analysis
ANOVA, mixed-effects models, and non-parametric approaches
Regulatory Reporting
Complete statistical reports for ANDA and MAA submissions
USFDA & EMEA Guidelines
Full compliance with FDA and EMA bioequivalence guidance documents
Industries We Serve
Specialized data solutions for diverse therapeutic areas and sectors
Biotech
Supporting emerging biotech companies with comprehensive data solutions from early-stage research through regulatory approval. Our flexible engagement models scale with your development needs.
- Early-stage biostatistics consultation
- CDISC implementation for first submissions
- Regulatory strategy support
Pharmaceutical
Full-spectrum support for pharmaceutical companies across all development phases, from preclinical studies to post-marketing commitments, with proven regulatory submission expertise.
- Phase I-IV clinical trial support
- NDA/BLA submission packages
- Post-approval study management
Radio Pharma
Specialized expertise in radiopharmaceutical development including imaging agents and therapeutic radiopharmaceuticals with unique regulatory considerations.
- Dosimetry data analysis
- Specialized safety assessments
- FDA radiopharmaceutical guidance compliance
Vaccine Development
Comprehensive support for prophylactic and therapeutic vaccine trials including immunogenicity assessments, efficacy evaluations, and safety monitoring.
- Immunogenicity analysis
- Vaccine efficacy endpoints
- Accelerated approval pathways
Oncology
Deep expertise in oncology trials including innovative trial designs, tumor response assessments (RECIST), survival analyses, and biomarker-driven studies.
- Survival analysis (OS, PFS)
- Tumor response assessments
- Adaptive oncology designs
Respiratory
Specialized support for respiratory disease studies including asthma, COPD, and pulmonary fibrosis with expertise in pulmonary function testing and patient-reported outcomes.
- Pulmonary function test analysis
- Exacerbation rate modeling
- Quality of life assessments
Central Nervous System (CNS)
Expert support for CNS disorders including neurodegenerative diseases, psychiatric conditions, and pain management with specialized outcome measures and regulatory pathways.
- Cognitive assessment analysis
- PRO instrument validation
- CNS-specific safety evaluations
Cardiovascular
Comprehensive cardiovascular trial support including heart failure, hypertension, and lipid disorders with expertise in MACE analyses and cardiovascular safety assessments.
- MACE endpoint analysis
- Cardiovascular safety studies
- Long-term outcome trials
Immunology
Support for autoimmune and inflammatory disease studies including rheumatoid arthritis, IBD, and psoriasis with specialized immunological assessments.
- Disease activity score analysis
- Biomarker correlations
- Long-term safety monitoring
Infectious Disease
Expertise in infectious disease trials including antibacterials, antivirals, and antifungals with specialized endpoints and resistance monitoring.
- Microbiological response analysis
- Resistance pattern evaluation
- Special pathogen studies
Metabolic/Endocrine
Comprehensive support for diabetes, obesity, and metabolic disorders with expertise in glycemic control measures and cardiometabolic endpoints.
- HbA1c and glucose monitoring
- Weight management studies
- MACE safety analyses
Hematology
Specialized support for hematologic disorders including anemias, bleeding disorders, and hematologic malignancies with complex laboratory endpoint analyses.
- Hematologic response criteria
- Transfusion independence analysis
- Bleeding event adjudication
Dermatology
Expert support for dermatologic conditions with specialized assessments including PASI, IGA, and other validated dermatology scales.
- PASI score analysis
- Photographic assessments
- Quality of life measures
Ophthalmology
Comprehensive support for ophthalmic trials including retinal diseases, glaucoma, and ocular inflammation with specialized vision endpoint analyses.
- Visual acuity assessments
- OCT and imaging analysis
- Ocular safety evaluations
Rare Diseases
Specialized expertise in rare disease development with innovative trial designs, natural history studies, and regulatory pathway navigation including accelerated approval.
- Small population trial designs
- Natural history analyses
- Orphan drug designation support
Pain Management
Expert support for acute and chronic pain studies with specialized pain assessment methodologies and abuse-deterrent formulation evaluations.
- Pain scale analysis (VAS, NRS)
- Opioid abuse-deterrent studies
- Chronic pain trial designs
Why Choose Eupraxia Consulting
Your trusted partner for regulatory submission excellence
FDA & EMEA Regulatory Alignment
Every service we deliver is designed with regulatory requirements at the forefront. Our team maintains deep expertise in FDA guidance documents, EMEA guidelines, and international regulatory standards.
- Comprehensive knowledge of FDA guidance documents
- EMEA EMA guideline compliance
- ICH harmonized standards (E3, E6, E9, M2, M4)
- Proactive regulatory intelligence monitoring
- First-time approval optimization
CDISC Standards Expertise
Our team includes highly experienced CDISC professionals with extensive expertise in SDTM, ADaM, and SEND implementations across hundreds of regulatory submissions.
- Highly experienced CDISC statistical programmers
- SDTM 3.3/3.4 implementation expertise
- ADaM 2.1 compliant datasets
- SEND 3.0/3.1 for nonclinical studies
- Define.xml 2.1 metadata generation
- FDA Technical Rejection prevention
End-to-End Coverage
From preclinical studies through market authorization and beyond, we provide seamless support across the entire drug development lifecycle.
- Preclinical toxicology data management
- Phase I-IV clinical trial support
- IND/NDA/BLA submission packages
- Post-approval commitments
- Medical device regulatory pathways
- Generic drug bioequivalence
Global Standards Expertise
We navigate complex international regulatory landscapes, ensuring your submissions meet requirements across multiple jurisdictions.
- USFDA and EMEA submission experience
- OECD guideline compliance (nonclinical)
- WHO and ICH standards
- Regional regulatory pathway knowledge
- Multi-regional clinical trial (MRCT) support
Experienced Team
Our multidisciplinary team brings decades of combined experience from CROs, pharmaceutical companies, and regulatory agencies.
- PhD and Master's level biostatisticians
- Senior statistical programmers (SAS, R)
- Clinical data management experts
- Regulatory affairs specialists
- Therapeutic area expertise
Flexible Engagement Models
We adapt to your needs with flexible service models that scale with your development programs and budget constraints.
- Full-service CRO partnership
- Functional Service Provider (FSP) model
- Project-based engagements
- Staff augmentation
- Consulting and advisory services
Quality & Speed
We deliver exceptional quality without compromising timelines, ensuring your programs stay on track for regulatory milestones.
- Rigorous QC processes (independent double programming)
- SOPs aligned with industry best practices
- Efficient project management
- Rapid turnaround capabilities
- 21 CFR Part 11 compliance
Innovation & Technology
We leverage cutting-edge technology and innovative methodologies to deliver superior data solutions.
- Advanced statistical methodologies
- Automation and validation tools
- Modern EDC platforms
- Cloud-based collaboration
- AI-assisted data review capabilities
Partner with Excellence
Join the biotech and pharma companies who trust Eupraxia Consulting for their most critical regulatory submissions.
Start a ConversationLet's Accelerate Your Regulatory Journey
Connect with our team to discuss how we can support your clinical development programs
Get in Touch
We're here to answer your questions and discuss how our end-to-end data solutions can accelerate your path to regulatory approval.
pkirkire@eupraxiaconsulting.com
linkedin.com/company/eupraxia-consulting
Global Office Locations
United States (Headquarters)
Eupraxia Life Sciences LLC
3000 Hadley Road, 3rd Floor
Office 233
South Plainfield, NJ 07080
United States
India - Vadodara Office
Eupraxia Centre for Clinical Excellence LLP
204-209, Sarathi Complex
Opp: Nutan Bharat Club, Alkapuri
Vadodara, Gujarat - 390007
India
India - Bangalore Office
Eupraxia Centre for Clinical Excellence LLP
No.18, 3rd Cross, Mcechs Layout
Thanisandra, Rachenahalli
Bengaluru, Karnataka, 560077
India
What We Offer
- Free initial consultation
- Customized service proposals
- Rapid response times
- Flexible engagement models