Clinical Data Management
CDASH-aligned eCRFs, edit-check validation, live cleaning, external-data reconciliation, medical coding, database lock and archival.
Discuss your studyClinical 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 study, one evidence chainEvery artifact traceable to the protocol
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 remain involved in delivery and review.
Discuss your protocol with a specialist →The team on your study
Named specialists, visible ownership and independent review.
Eight study-delivery specialists are supported by executive, quality, regulatory, technology and operational leadership. Named functional owners stay visible from kick-off through final acceptance.
15Named professionals
8Study-delivery staff
7Leadership and enablers
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.
Biostatistics & Programming
Study design, randomization, SAPs, DSMB support, efficacy and safety analysis, BE/PK statistics, ADaM, TLFs and agency responses.
Discuss your studyConnected eClinical Suite
Validated EDC, IWRS, ePRO, eTMF, LUP analytics/CDISC and safety platforms configured around the study workflow.
Discuss your studyPharmacovigilance
Case processing, SAE reconciliation, E2B(R3), aggregate reporting, signal support and safety analytics.
Discuss your studyEngage 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, randomization, 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 shown · 4 delivery stagesOngoingGB-ONC-26-01
Dose-escalation oncology program
Therapeutic areaOncology
Study designPhase I · Dose escalation / expansion
RegionUnited States
Current milestoneDose-escalation data reviews
Galaxbiotech scope
- Biostatistics and SAP
- SDTM and ADaM
- TLF programming and QC
- DSMB support
OngoingGB-END-26-02
Multiple-dose endocrine study
Therapeutic areaEndocrinology
Study designPhase I · Single-arm, multiple dose
RegionNorth 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.
Capture, control, standardize and analyze clinical data through validated products designed around the way regulated studies actually operate—with study-by-study deployment or a connected full stack.
Explore the productsGALAXConnected evidence
EDCData captureIWRSRandomizationePROPatient dataeTMFTrial master file
LUPAnalytics & CDISCSafetyICSR & signal oversight
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.
Statistics and data management in one room
Analysis intent shapes collection design, so mapping and cleaning do not become repair work later.
We own the technology
No licence markup and no waiting for a separate vendor release cycle when a study configuration needs to change.
Submission-shaped from the start
CDISC structures, traceability and define-readiness are built during conduct—not reconstructed at the end.
Time-zone advantage, used deliberately
Overnight review cycles are planned when the study calendar is under pressure, without weakening review discipline.
Commercially proportionate
A specialist India-based delivery base gives sponsors senior capability at a workable cost structure.
The specialists behind delivery
BiostatisticiansStatistical programmersClinical data managersEDC & validation specialistsPharmacovigilance professionalsQuality 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.
Oncology & hemato-oncology
Vaccines & infectious disease
Neurology & CNS
Immunology & rheumatology
Rare & orphan diseases
Endocrinology & metabolic
Cardiovascular
Respiratory
Renal & nephrology
Gastroenterology & hepatology
Dermatology
Women’s health
Complex study contextsBA/BEFIHSAD/MADDose escalationCrossoverGlobal Phase I–IV
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.
info@galaxbiotech.com+1 (609) 945-0088+91 916 916 5284Gaurav ChauhanFounder and CEO, on LinkedIn