FAQ

No. ClinScreen is decision-support software for patient recruitment. It suggests protocol-grounded follow-up questions and produces a criteria-mapped summary with suggestions for the study team, but it does not make eligibility determinations. Decisions and next steps remain with the study team.

No. ClinScreen supports human-led pre-screening calls by flagging potentially relevant inclusion/exclusion criteria, tracking uncertainty, and suggesting clarifying questions. ClinScreen does not automatically determine protocol eligibility.

ClinScreen is primarily used by Patient Recruiters and Clinical Research Coordinators conducting pre-screening calls. It is designed to be easy for appropriately trained site staff to use, helping reduce protocol-specific ramp time and improve consistency. Recruitment leads and managers can also use ClinScreen to standardize handoffs across multiple study recruiters and protocols.

If a patient is not a good match for the originally intended study, ClinScreen can suggest alternative active studies configured by your site and show the criteria-level reasons. This helps sites salvage potential participants instead of losing them.

By design, no. ClinScreen is built to keep raw call audio and raw transcript text local on the device by default. Cloud services use study documents plus structured, non-identifying eligibility facts generated during the workflow. This design reduces PHI exposure and helps support compliance with applicable regulations and policies.

ClinScreen can operate without identifiers. Direct identifiers are optional and OFF by default. If enabled, the intent is to store identifiers locally only, based on each site’s preferences and policies.

By default, raw audio and raw transcripts remain on the device and are designed for session-only retention unless a site configures otherwise. Cloud retains only non-identifying structured call facts and administrative study data needed for functionality and auditability.

In most cases, a Business Associate Agreement (BAA) is not required because ClinScreen is designed to avoid transmitting raw transcripts/audio and direct identifiers to cloud services. Your compliance team should make the final determination based on your policies and implementation configuration.

ClinScreen does not require Part 11 validation because it is designed as decision support, and it is not a regulated e-records system of record. It provides controls such as role-based access control and audit logging for key actions, and produces exports that sites can incorporate into their established workflows.

ClinScreen is designed to support HIPAA-aligned workflows by minimizing PHI exposure by default. In Local-only mode, raw call audio and raw transcripts are designed to remain on the MacBook, and direct identifiers are optional and OFF by default. Whether HIPAA applies to your deployment (and whether a BAA is required) depends on your policies and configuration; your compliance team should make the final determination.

ClinScreen is not currently SOC 2 or ISO/IEC 27001 certified. SOC 2 is an independent audit report and ISO 27001 is a formal certification; both require external assessment. But our security program is aligned with these frameworks and built around common control expectations (e.g., access controls and least privilege, logging and monitoring, secure development practices, vulnerability management, and incident response). We can share security documentation and respond to vendor security questionnaires, and we plan to pursue formal SOC 2 and/or ISO 27001 soon.

ClinScreen is designed for on-device transcription during a pre-screening call. Whether that is treated as “recording” (and whether consent is required) depends on your site’s policies and applicable local laws. If a patient opts out, ClinScreen can run in a reduced-assistance mode without transcription for that call.

Typical steps include: upload protocols/ICFs, review and approve extracted criteria before activation, onboard users, verify audio capture and transcription setup, and produce structured summaries that your team can transfer into your existing workflow.

ClinScreen is designed for a two-device workflow: the recruiter runs the call on their phone, while ClinScreen runs on a shared site MacBook as the on-screen copilot. Audio capture can be as simple as speakerphone, or an optional wired tap kit for cleaner audio. We can share a short recommended setup list during onboarding.

ClinScreen supports structured exports (e.g., summary and criteria-mapped snapshot) that teams can transfer into their existing workflows. Integrations are limited at this time, but specific system integrations can be discussed based on a site’s situation.