Overview

Platform overview

Biome is a self-serve clinical operations platform for research teams. You bring a ready study — Biome runs the operational layer: recruitment, screening, sample-kit logistics, milestone and compliance tracking, a document vault, and compensation payouts. Everything you need to run your study independently, on your terms.

Research teams get a single place to manage the full operational lifecycle of a human research study, with a complete audit trail from first applicant to final report.

What Biome is

Biome is operations infrastructure. It moves a study from "we need a screened cohort" to "our cohort has completed the protocol, every sample is accounted for, and every payout is documented."

Specifically, Biome provides:

  • Recruitment and screening: applicant sourcing, eligibility screening, and cohort selection tools
  • A document vault: IRB/ethics approval, study protocol, agreements, and consent forms stored with clearance-based access, with contracts e-signed in place
  • Sample-kit logistics: kit dispatch, returns, and chain-of-custody tracking for every sample
  • Milestone and compliance tracking: a per-person checklist of protocol checkpoints with verification and dropout-risk alerts
  • Compensation infrastructure: budgets deposited upfront and held, payouts released against verified completion, with a full audit trail
  • Compliance export: a complete record bundle and final report at study close

What Biome is not

Biome is not a sponsor, a medical provider, or an ethics board. Researchers remain fully responsible for the design, conduct, safety, and regulatory compliance of their studies. Biome provides operational infrastructure — not clinical oversight.

Biome does not provide or obtain IRB or ethics approval. You bring your own approval from your institution or an independent board. Biome stores it in your study's document vault and verifies it is on file before your study can launch.

Biome also does not design studies, provide medical advice, or guarantee study outcomes.

How a study runs on Biome

The researcher flow follows a defined sequence:

  1. 1Request an estimate — submit an intake describing your study scope (cohort size, sample types, duration, geographies)
  2. 2Scoping call and operations plan — review a transparent, line-item quote and agree the ops plan before committing
  3. 3Document vault setup — upload your IRB/ethics approval, study protocol, and agreements; e-sign the service contract; consent forms are managed with clearance-based access
  4. 4Study setup — define milestones, screening criteria, and the compensation schedule
  5. 5Recruitment and screening — applicants apply, are screened against your criteria, and you select your cohort
  6. 6Live operations — kit logistics with chain-of-custody, milestone tracking, pseudonymised messaging with research partners, and dropout-risk alerts
  7. 7Compensation payouts — released against verified completion, with a full audit trail
  8. 8Compliance export and final report — a complete record bundle at study close

Key concepts

Study— A research protocol run on Biome with defined milestones, screening criteria, duration, and a compensation schedule.
Research partner— A person who applies to studies, completes milestones, and receives compensation for verified participation.
Researcher— A member of a research team who sets up and manages studies, screens applicants, verifies milestones, and oversees payouts.
Document vault— The secure store for each study's IRB/ethics approval, protocol, agreements, and consent forms, with clearance-based access and in-place e-signing.
Milestone— A required task or checkpoint within a study protocol. Milestones are organized by week and form the basis of compliance scoring.
Compliance score— The share of verified milestones completed out of total milestones required. This determines compensation eligibility.
Chain of custody— The tracked record of every sample kit from dispatch, through collection and transit, to lab receipt.
Operations fee— Biome's fee for running your study, quoted per study as part of a transparent line-item estimate.
Participant ID— A permanent, anonymized identifier in the format P-XXXX-XXXX assigned to every research partner at registration.
Pseudonym— A permanent, randomly generated display name (e.g., SilentOrbit221) used in place of real names across the platform.