The team on your study
Named specialists, visible ownership and independent review.
15Named professionals
8Study-delivery staff
7Leadership & enablers
Named functional owners stay visible from kick-off through final acceptance.
Clinical technology and biometrics
Better trials begin with connected expertise.
A specialist clinical research and technology partner for sponsors who need biostatistics, data management, CDISC programming, pharmacovigilance and eClinical software to move as one workflow, not as separate contracts.
Phase I–IV · BA/BE · FIH · oncology, vaccines and rare disease
One partner, one evidence chainServices and software from the same team
01 Expert services
- Clinical data managementeCRF, cleaning, coding, lock
- Biostatistics & programmingSAP, randomisation, TLFs
- CDISC standardsSDTM, ADaM, define.xml
- PharmacovigilanceICSRs, E2B(R3), DSUR/PSUR
02 Galax platform
+13 more modulesOne sign-in · one audit trail · 21 CFR Part 11
03 Submission-ready evidence
- Clean locked database
- SDTM / ADaM
- TLFs
- CSR & eCTD
Why Galax
Senior experience stays close to the work.
Galaxbiotech was built by professionals who have designed studies, programmed submission outputs, managed clinical databases and answered sponsor and regulatory questions themselves. The people shaping the solution stay involved in delivery and review.
Discuss your protocol with a specialist →
Gaurav ChauhanFounder & CEO
Leads Galax across clinical data science, biostatistics, CDISC, software and GxP compliance — and stays involved in study delivery and review.
- CDISC SDTM & ADaM
- BA/BE statistics
- 21 CFR Part 11 & ALCOA+
- ICH E6 / E9
How we work
- 01Senior-led delivery
Specialists who scoped the study stay on it through lock and submission.
- 02Named functional owners
One accountable lead per function, visible to the sponsor at every milestone.
- 03Independent QC & review
Outputs are checked by someone who did not produce them, with documented sign-off.
Services
Everything your evidence journey needs. Connected by design.
Our systems and experts share the same clinical context. That means fewer handoffs, clearer ownership and a continuous line of traceability.
Clinical Data
Clinical Data Management
CDASH-aligned eCRFs, edit-check validation, live cleaning, external-data reconciliation, medical coding, database lock and archival.
- Data management plan
- eCRF & edit-check specs
- Query management
- MedDRA / WHODrug coding
- Database lock
Biometrics
Biostatistics & Programming
Study design, randomisation, SAPs, DSMB support, efficacy and safety analysis, BE/PK statistics, ADaM, TLFs and agency responses.
- SAP & sample size
- Randomisation
- SDTM / ADaM
- TLFs & QC
- PK / BE statistics
Patient Safety
Pharmacovigilance
Case processing, SAE reconciliation, E2B(R3), aggregate reporting, signal support and safety analytics.
- ICSR processing
- SAE reconciliation
- E2B(R3) submissions
- DSUR / PSUR
- Signal management
Technology
Connected eClinical Suite
Every module runs on one validated Galax platform with a single sign-on, one audit trail and shared study metadata, configured around your study workflow.
Data capture & trial operations9
Analytics, standards & AI2
Safety, quality & compliance4
Regulatory submissions2
Engage us at any stage
Clear ownership. Defined deliverables.
From an individual statistical question to full study delivery, every engagement begins with the protocol, the regulatory objective and an agreed responsibility matrix.
01
Study design & start-up
Sample size, endpoint strategy, randomisation, statistical sections, data standards strategy and protocol review.
Outputs
SAP framework · eCRF strategy · shells · specifications
02
Database build & conduct
EDC configuration, edit checks, DMP, UAT, medical coding, reconciliation, cleaning and lock readiness.
Outputs
Validated database · DMP · UAT evidence · clean data
03
Standards & statistical analysis
SDTM, ADaM, define.xml, reviewer guides, PK/NCA, modelling, TLF programming and independent QC.
Outputs
Submission datasets · TLFs · QC records · interpretation
04
Reporting & submission support
CSR statistical sections, integrated review, traceability, responses to questions and inspection support.
Outputs
CSR content · submission package · response support
Pipeline
Active work. Clear scope. Visible progress.
An NDA-safe view of representative projects across the delivery lifecycle. Sponsor names and protocol identifiers are withheld; detailed references are available during qualification.
7 projects · 4 delivery stages
Ongoing
GB-ONC-26-01Dose-escalation oncology program
- Therapeutic area
- Oncology
- Study design
- Phase I · Dose escalation / expansion
- Region
- United States
Current milestoneDose-escalation data reviews
Galaxbiotech scope
- Biostatistics and SAP
- SDTM and ADaM
- TLF programming and QC
- DSMB support
Ongoing
GB-END-26-02Multiple-dose endocrine study
- Therapeutic area
- Endocrinology
- Study design
- Phase I · Single-arm, multiple dose
- Region
- North America
Current milestoneClinical database conduct
Galaxbiotech scope
- EDC build and validation
- Clinical data management
- Medical coding and reconciliation
- Biometrics support
Products
One evidence chain. No disconnected systems.
Every Galax module runs on the Galax System: one sign-in, one role model, one set of e-signatures and one hash-chained audit trail. Deploy a single module for one study or connect the full stack.
Explore all 17 modules
Galax EDC & eCRF
Clean clinical data—from protocol to database lock.
- Global, client and sponsor form and study-schema libraries
- Edit checks, derivations, query lifecycle, SDV, medical review and PI signature
- Role- and mode-based sign-in across EDC, IWRS, ePRO, eTMF, Safety, Lab, eCDT, RBQM and Site Monitoring
Galax IWRS
Randomisation and drug supply in one controlled workflow.
- Screening, randomisation schemas and subject allocation
- Dose-escalation study support
- Kit preparation, inventory, depots and shipments
Galax ePRO
Make the patient experience part of the evidence chain.
- Assessment configuration and participant schedules
- Guided patient data capture
- Completion oversight and data review
Galax LUP
One language from raw data to signed-off TLFs.
- GLX language with Code, Visual, Graphical and Guided views
- SDTM conversion with a drafted, reviewable SDA mapping
- Demographics, disposition, AE, findings, shift and frequency tables
Also on the Galax System
13 more modules, one validated core.
Every module shares the same sign-in, role model, e-signatures and audit trail.
- Data capture & operations
- Analytics & AI
- Safety, quality & compliance
- Regulatory
LABLab DataCentral & local labseCDTeCDTVendor data transferRBQMRBQMRisk-based qualitySMSite MonitoringSite oversightCTMSCTMSTrial managementeTMFeTMFTrial master fileAIGalax Gen AIGenerative AI · in trainingPVSafety DatabasePharmacovigilanceGSRSSafety Reporting SystemSafety reportingeQMSeQMSQuality managementTMSTMSTraining recordseCTDeCTD PublishingRegulatory publishingRIMRIMRegulatory information- Explore all 17 modulesCapabilities, videos and validation scope for every module.View catalogue
Case studies
Evidence of delivery.
NDA-safe engagement summaries. Detailed scope, sample artifacts and references are available during qualification.
Five FDA-submission studies executed through a controlled data lifecycle.
Three Phase I studies, including SAD/MAD first-in-human, one Phase III and one Phase IV study used Galax EDC for protocol interpretation, CDASH-aligned build, formal UAT, live cleaning, controlled change and SDTM-ready delivery.
5FDA-submission studies
4 weeksBuild to go-live
23%Queries auto-fired
0Data-integrity findings
Rare disease, oncology and vaccine programs shaped from SAP through submission.
Estimand-driven SAPs, oncology TU/TR/RS and vaccine IS domains, ADTTE/ADRS/ADIS derivations, survival and immunogenicity methods, specialized graphics and independently programmed primary endpoints.
30+Complex studies delivered
P21-cleanCDISC packages
4 weeksDSMB output cycles
No reworkPFS/OS censoring logic
Delivery model
A delivery model designed to reduce sponsor risk.
Strong work is not only about technical capability. It requires visible ownership, reproducibility and timely decisions throughout the engagement.
Senior people on the study
The experience that wins the work is the experience that runs it, without a handover to a junior bench after kick-off.
Continuity of expertiseStatistics and data management in one room
Analysis intent shapes collection design, so mapping and cleaning do not become repair work later.
Fewer late fixesWe own the technology
No licence markup and no waiting for a separate vendor release cycle when a study configuration needs to change.
Faster change, lower costSubmission-shaped from the start
CDISC structures, traceability and define-readiness are built during conduct, not reconstructed at the end.
Submission-ready dataTime-zone advantage, used deliberately
Overnight review cycles are planned when the study calendar is under pressure, without weakening review discipline.
Shorter turnaroundCommercially proportionate
A specialist India-based delivery base gives sponsors senior capability at a workable cost structure.
Senior capability, fair costThe specialists behind deliveryOne integrated team, not a chain of subcontractors.
- Biostatisticians
- Statistical programmers
- Clinical data managers
- EDC & validation specialists
- Pharmacovigilance professionals
- Quality reviewers
Therapeutic experience
Depth where study design gets difficult.
Senior specialists bring clinical and statistical context to complex endpoints, dense schedules and evolving regulatory expectations.
Complex study contexts
- BA/BEBioavailability & bioequivalence
- FIHFirst-in-human
- SAD/MADSingle & multiple ascending dose
- DEDose escalation
- XOCrossover & replicate designs
- I–IVGlobal Phase I–IV
- ONCOncology & hemato-oncology
- VAXVaccines & infectious disease
- CNSNeurology & CNS
- IMMImmunology & rheumatology
- RARERare & orphan diseases
- ENDOEndocrinology & metabolic
- CVCardiovascular
- RESPRespiratory
- RENALRenal & nephrology
- GIGastroenterology & hepatology
- DERMDermatology
- WHWomen’s health
Quality
Ready for scrutiny at every step.
Controlled, documented workflows designed for regulated clinical research—not quality added at the end.
21 CFR Part 11ICH-GCPCDISCALCOA+CSV / IQ-OQ-PQRole-based security
01Risk assessment
GAMP 5 category and risk scope defined before configuration.
02Specification
Requirement-to-specification traceability maintained.
03Qualification
IQ/OQ/PQ evidence reviewed and deviations resolved.
04Controlled change
Every change re-enters the documented control loop.
Available during sponsor qualification
Quality-system overview · SOP index · validation summary · security and backup overview · audit-support approach
Request the qualification packageContact
What can we help you solve?
Share your protocol synopsis or delivery gap. We will respond with a senior point of contact, proposed scope, key assumptions, deliverables and an achievable timeline.
Clinical data science · biostatistics · CDISC · GxP compliance
in Connect on LinkedInStart a conversation
- Protocol synopsis or study design
- Timelines and key milestones
- The scope or delivery gap you need covered
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