Beyond labs / Biopharma, CROs, and health systems

The consultation framework
extends well beyond
the clinical laboratory.

Pathologist-led interpretation of complex diagnostic data is valuable wherever a structured result needs to become a defensible clinical decision. That includes clinical trial central labs, biopharma research operations, contract research organizations, and integrated health systems.

/ 01 / Audience

Biopharma sponsors and
clinical trial operations.

For sponsors running trials that depend on consistent, defensible pathology interpretation across sites.

Clinical trials in infectious disease, oncology, immunology, and rare disease often hinge on how diagnostic results are interpreted across enrolled sites. When interpretation varies between sites, the data variance becomes the story instead of the therapy.

AICC provides centralized pathologist consultation for sponsor trials: consistent interpretation across every site, every case, every visit. Board-certified pathologists review the structured molecular or laboratory data, apply the protocol-specified clinical framework, and return a signed consultation that aligns with the sponsor's reporting requirements.

Used alongside a sponsor's central laboratory or as a specialist interpretation overlay on existing site-level testing.

Where this fits
  • Phase 2 and Phase 3 trials Centralized pathology interpretation for endpoint analysis where consistent reading matters more than site convenience.
  • Companion diagnostic development Pathologist consultation on biomarker results during co-development with a therapeutic.
  • Real-world evidence studies Standardized interpretation of decentralized diagnostic data for post-market and observational studies.
  • Adjudication and second-read panels Expert pathologist review for cases flagged at the site level or for data quality assurance.
/ 02 / Audience

Contract research
organizations.

For CROs running studies that need centralized clinical pathology interpretation without building it in-house.

Contract research organizations often manage diagnostic and laboratory operations for sponsor trials but do not maintain a board-certified pathology team for clinical interpretation. Building one is expensive, hiring one is competitive, and using one inconsistently introduces variability the sponsor will not accept.

AICC operates as a specialist interpretation partner for CROs: a credentialed pathology team available on a per-study basis, integrated into the CRO's existing data and reporting workflow, branded as the CRO requires. The CRO maintains the sponsor relationship. AICC supplies the specialist judgment behind the report.

This is the same engine-under-the-hood model we run for clinical laboratories, applied to the trial context.

Where this fits
  • Central laboratory operations Pathologist consultation overlay on CRO-managed central lab testing for infectious disease and molecular panels.
  • Specialty study support Per-study pathology consultation for trials that need specialist judgment without a permanent hire.
  • Sponsor-facing reporting Signed consultation reports formatted for sponsor data systems and protocol-aligned reporting requirements.
  • Surge capacity Pathologist availability during high-volume enrollment windows where internal teams would be stretched.
/ 03 / Audience

Integrated health systems
and hospital networks.

For health systems whose providers need real interpretive support on complex molecular results, system-wide.

Health systems often run molecular diagnostics across multiple sites, multiple instruments, and multiple provider workflows. The result is a flood of complex structured data with uneven interpretive support. Some providers know what a resistance gene cascade means. Most do not. The system-wide answer is often empirical broad-spectrum therapy, which is exactly what the system's stewardship committee is trying to prevent.

AICC fits in as a system-wide pathologist consultation layer. Every complex case across every site gets the same standard of interpretation: a board-certified pathologist's signed recommendation, anchored in current guidance, returned to the ordering provider in the system's reporting environment.

This is particularly valuable for systems with antimicrobial stewardship goals, broad geographic footprints, or rural and community sites that do not have specialist consultation available locally.

Where this fits
  • Stewardship-aligned reporting Consistent narrowest-effective-therapy recommendations across all system sites, with the pathologist's signature on every report.
  • Multi-site standardization One interpretive standard regardless of which hospital or clinic in the system ordered the test.
  • Rural and community site support Specialist pathology consultation for sites that cannot recruit or retain a dedicated specialist locally.
  • Provider satisfaction Real interpretive help for the clinicians ordering complex tests, not just data dumped into the EHR.

One consultation framework.
Three different contexts.

/ Same engine

Board-certified pathologist on every case.

Whether the request comes from a clinical laboratory, a sponsor trial, a CRO, or a health system, the underlying service is the same: a credentialed pathologist reviews the case and signs the consultation. The discipline does not change.

/ Same standard

Stewardship-aligned, evidence-anchored.

Every consultation recommends the narrowest effective approach the evidence supports. The standard is the same across contexts because clinical responsibility is the same across contexts.

/ Different delivery

Branded for the partner who delivers it.

Reports arrive branded as the laboratory, the CRO, the sponsor, or the health system. AICC is the specialist underneath, not the brand on the page. The partner relationship belongs to the partner.

/ Different integration

Fit to the partner's existing workflow.

Integration matches the operational reality of the partner. A clinical lab's reporting environment is different from a CRO's data system, which is different from a health system's EHR. The consultation flows in wherever the partner already operates.

Tell us what you are
trying to solve.