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Healthcare · head to head

OpenClinica vs PathAI

OpenClinica logo

OpenClinica

Healthcare

Clinical trial EDC with a genuinely open source community edition alongside a quoted commercial platform

From
On request
Rated
-
PathAI logo

PathAI

Healthcare

Digital pathology image management with an FDA cleared platform for primary diagnosis

From
On request
Rated
-

The short version

  • Each has a real cost: OpenClinica the free community edition is a different and older product line from the commercial platform, so evaluating the open source build tells you little about what the paid product actually does.; PathAI aISight is labelled research use only and cannot be used for primary diagnosis; only AISight Dx carries the FDA clearance and CE-IVD mark, and laboratories regularly buy the wrong configuration and discover they cannot sign out on it.
  • They diverge on capability: OpenClinica covers Open source community edition, PathAI covers AISight image management.
  • Prices and features above were last checked on 1 September 2026.

Where they differ

Only the attributes on which OpenClinica and PathAI actually diverge.

Attributes where OpenClinica and PathAI differ
AttributeOpenClinicaPathAI
PlatformsWeb, Self-hosted, iOS, AndroidWeb

Identical on both: starting price (On request), pricing model (quote), free tier (No), user rating (Not yet rated), category (Healthcare).

What each one covers

Drawn from each product's published feature list. An absence here means we hold no record of it - not that the product lacks it.

Only in OpenClinica

  • Open source community edition
  • Electronic data capture
  • eConsent
  • eCOA and ePRO
  • Randomisation
  • EHR-to-EDC
  • Audit trail
  • Reporting and analytics

Only in PathAI

  • AISight image management
  • AISight Dx
  • Scanner interoperability
  • Case and worklist management
  • AI algorithm deployment
  • Biopharmaceutical research tooling
  • LIS integration

What people use each for

The jobs each tool is most often brought in to do.

OpenClinica

  • An academic coordinating centre running investigator-initiated trials that needs Part 11 compliant capture without an enterprise eClinical budgetnot PathAI
  • A registry or observational cohort study collecting structured data across many sites over yearsnot PathAI
  • A small device sponsor that needs eConsent and ePRO in the same system as its case report formsnot PathAI
  • An informatics group that wants to self-host the open source edition for a non-regulated internal studynot PathAI

PathAI

  • An academic medical centre going digital for primary diagnosis that needs the FDA cleared AISight Dx configuration rather than the research labelled versionnot OpenClinica
  • A reference laboratory consolidating subspecialty sign out across sites so a specialist pathologist can read cases from any locationnot OpenClinica
  • A pharmaceutical company needing consistent quantitative scoring of trial biopsies across many sites and readersnot OpenClinica
  • A laboratory with a mixed scanner estate that needs one image management layer rather than each scanner vendor viewernot OpenClinica

Where each one falls short

Documented limitations, not opinions. Every one is a constraint you would hit in normal use.

OpenClinica

  • The free community edition is a different and older product line from the commercial platform, so evaluating the open source build tells you little about what the paid product actually does.
  • The vendor provides no support or services at all for the community edition, which means outages, patching, database upgrades and validation documentation are entirely your problem.
  • Commercial pricing is not published, so you cannot benchmark it against alternatives without entering a sales process, and third-party figures around USD 1,000 a month are indicative rather than contractual.
  • Study build is skilled work: complex edit checks, randomisation schemes and integrations usually mean paying for vendor or consultant configuration services on top of the licence, which is a frequently underestimated line in the budget.
  • As a smaller vendor than the large eClinical suites it has a thinner partner and consultant ecosystem, so finding experienced build staff or a CRO already fluent in the platform is harder than with the market incumbents.

PathAI

  • AISight is labelled research use only and cannot be used for primary diagnosis; only AISight Dx carries the FDA clearance and CE-IVD mark, and laboratories regularly buy the wrong configuration and discover they cannot sign out on it.
  • The software licence is usually the smallest line in a digital pathology project, behind scanners, storage and network capacity, so a business case built around the software cost understates the real investment by a wide margin.
  • Whole slide images are very large, so a laboratory that does not model storage growth and retention policy from the start faces storage costs that grow faster than case volume and dominate the renewal.
  • Clinical validation is required per subspecialty rather than once for the platform, which means dermatopathology, gastrointestinal and breast each need their own concordance study and pathologist time before go live.
  • PathAI competes against pathology incumbents that also sell the scanners, and a laboratory buying an independent image management layer takes on the integration risk between scanner vendor and software vendor itself.

Pricing, plan by plan

OpenClinica

On request
  • Community Edition$undefined/year
    • Free and open source under the LGPL
    • Self-hosted, on the older 3.x line
    • No vendor support or services of any kind
  • OpenClinica Enterprise$undefined/year
    • Pricing only through a sales process
    • Hosted and validated instance
    • EDC, eConsent, eCOA, randomisation and analytics modules

PathAI

On request
  • AISight$undefined/year
    • Priced by annual slide or case volume and by pathologist seats
    • AISight Dx, the clinically cleared configuration, quoted separately from research use AISight
    • Image storage priced by capacity and retention policy

Which should you pick?

Choose OpenClinica if

  • You need open source community edition.
  • You work on Web, Self-hosted, iOS, Android.
  • You also want electronic data capture.

Choose PathAI if

  • You need aisight image management.
  • You also want aisight dx.

Questions people ask

Is OpenClinica or PathAI better?
Neither clearly leads. OpenClinica starts at On request and PathAI at On request, and user ratings are close enough to be indistinguishable. Choose on capability and platform support.
Which is cheaper, OpenClinica or PathAI?
OpenClinica starts at On request and PathAI at On request.
Does OpenClinica or PathAI run on more platforms?
OpenClinica runs on Web, Self-hosted, iOS, Android. PathAI runs on Web.
What is OpenClinica best used for?
OpenClinica is most often used for an academic coordinating centre running investigator-initiated trials that needs part 11 compliant capture without an enterprise eclinical budget, a registry or observational cohort study collecting structured data across many sites over years, a small device sponsor that needs econsent and epro in the same system as its case report forms, an informatics group that wants to self-host the open source edition for a non-regulated internal study. Of those, an academic coordinating centre running investigator-initiated trials that needs part 11 compliant capture without an enterprise eclinical budget and a registry or observational cohort study collecting structured data across many sites over years are not what PathAI is typically brought in for.
What can OpenClinica do that PathAI cannot?
OpenClinica covers Open source community edition, Electronic data capture, eConsent, eCOA and ePRO. PathAI covers AISight image management, AISight Dx, Scanner interoperability, Case and worklist management.

Answered from the vendors’ own pages

OpenClinica: Is OpenClinica free?

There is a genuinely free, LGPL licensed community edition you host yourself with no vendor support. The commercial platform with eConsent, eCOA and a validated hosted instance is quoted and paid.

PathAI: What is the difference between AISight and AISight Dx?

AISight is for research use only and not for clinical diagnostic use. AISight Dx received FDA 510(k) clearance in June 2025 for primary diagnosis and is CE-IVD marked in the EEA, UK and Switzerland. Only the Dx configuration can be used to sign out cases.

OpenClinica: Is the open source version still maintained?

Yes, releases on the 3.x line continued through 2025, but it is a separate and older architecture from the commercial product.

PathAI: Can we use our existing scanners?

Yes. AISight is designed to ingest images from multiple whole slide scanner vendors, which is one of the main reasons laboratories choose an independent image management layer.

OpenClinica: Does it meet 21 CFR Part 11?

The commercial hosted platform is built for Part 11 and GCP compliance. If you self-host the community edition, compliance and validation are entirely your responsibility.

PathAI: Do the AI algorithms carry the same clearance as the platform?

No. The platform clearance covers image management for primary diagnosis. Individual algorithms have their own labelling, and many are research use only. Check each one separately.

OpenClinica: What does the commercial version cost?

Not published. Third-party listings suggest enterprise arrangements from around USD 1,000 per month, but real cost depends on study count, subjects, modules and build services.

PathAI: Is pricing published?

No. It is quoted by slide or case volume, pathologist seats and storage, with the clinically cleared configuration priced separately.

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