Integrate Clinical Claims Studies with Confidence
HelloBiome plugs directly into your existing studies, giving CROs a scalable way to deliver microbiome endpoints with scientifically rigorous, sponsor-ready results. Studies run faster, data quality stays high, and your team doesn’t need to build new infrastructure.
Clinical
Research
Organizations
Provide Your Sponsors with the Claim Studies They Want
As sponsors demand more advanced endpoints, CROs are under pressure to evolve. HelloBiome gives CROs a reliable, validated way to deliver them — with standardized workflows, CLIA/CAP-accredited analysis, and claims-ready outputs that meet the rigor sponsors expect.
Simple Operations
Testing kits and workflows integrate seamlessly with existing operations.
Reliable
Data
High sample quality and reproducible analysis from CLIA/CAP-accredited labs.
Advanced Endpoints
Add high-value microbiome endpoints to standard safety or efficacy studies.
Quick Turnaround
Microbiome analysis and structured reports delivered in days, not weeks.
HelloBiome Expands Your Clinical Claims Studies Capabilities Seamlessly
We work as your microbiome intelligence platform. You stay in control. We handle the complexity.
1. Seamless Expansion
Advanced Endpoints, Without the Headcount
HelloBiome plugs directly into your existing studies — letting you offer advanced microbiome insights without building internal bioinformatics infrastructure or hiring specialized staff.
2. Operational Lift
We Handle the Messy Middle
From sample kits to sequencing and quality control, we manage the operational complexity behind microbiome testing. Your team stays focused on execution, compliance, and timelines—not logistics.
3. Sponsor-Ready Outputs
Results Your Sponsors Can Act On
Complex data is only valuable if it’s usable. We translate microbiome results into clear, structured reports and visuals—so sponsors get insights they can understand, trust, and use immediately. From claims-ready datasets to strategic microbiome analysis, every output is designed to move decisions forward.
Clinical Claims Studies for CROs
Validate microbiome impact with the rigor and speed your sponsors expect — and deliver structured, claims-ready outputs that translate complex data into defensible results.
Expand Your Study Capabilities
Talk to our team and discover how HelloBiome helps you offer advanced microbiome endpoints without operational complexity.
Everything You Need to Know
Common questions about HelloBiome for clinical research organizations
How does HelloBiome integrate with existing studies?
HelloBiome works as a white-label platform that plugs directly into your existing study design. No disruption to your workflows, no new infrastructure required. We handle sampling logistics, sequencing, and analysis while you maintain full control over sponsor communication and final reporting.
What about sample handling?
Sampling is conducted on-site at the CRO facility under the control of your staff, using HelloBiome’s standardized collection kits. Kits are designed for ease of use with clear protocols and built-in quality controls — maintaining the data integrity required for defensible results without adding operational burden to your team.
How fast are the reports?
Microbiome analysis and structured reports are delivered in days, not weeks. Every output is designed to be sponsor-ready — clear visuals, interpreted results, and claims-relevant insights your team can hand over without additional formatting or translation.
Can we offer advanced endpoints?
HelloBiome enables CROs to add microbiome endpoints to standard safety or efficacy studies without building internal bioinformatics capabilities. This gives your team a competitive edge when sponsors are looking for more advanced, science-backed study designs.
What about data reliability?
All sequencing is processed through CLIA- and CAP-accredited laboratory workflows, profiling across 10,000+ species per sample. HelloBiome’s proprietary scoring models go beyond taxonomic tables to measure microbiome balance, stability, and functional shifts — ensuring every dataset is reproducible, defensible, and built to the highest scientific standards.