Artificial Intelligence at BioAgilytix
BioAgilytix is thoughtfully introducing artificial intelligence and AI-assisted technologies to strengthen the quality, consistency, traceability, and reliability of selected workflows and services.
Our approach is grounded in a simple principle:
AI may assist our people and processes, but BioAgilytix remains accountable for the work we perform and the services we deliver.
AI-assisted capabilities may be in evaluation, validation, controlled introduction, or production use depending on the specific technology, intended use, and associated risk.
This page provides a current view of AI-assisted technologies used in connection with client services and will be updated as applicable technologies are introduced or materially changed.
How BioAgilytix Uses AI
Current and anticipated applications of AI-assisted technology include:
- assisting with preparation of scientific and technical documentation;
- extracting, organizing, and reconciling information from documents and data sources;
- identifying potential inconsistencies or information requiring human review;
- supporting data analysis and information retrieval;
- supporting consistent and well-controlled workflows; and
- improving access to relevant information and supporting consistent collaboration, project coordination, and software-enabled processes.
The specific capabilities used may vary by service, workflow, and stage of implementation.
AI-Assisted Technologies
BioAgilytix maintains information below regarding AI-assisted technologies used in connection with client services. The information is intentionally focused on the purpose of the technology and the controls relevant to client work, rather than proprietary implementation details.
This information will be updated as applicable AI-assisted technologies are introduced or materially changed.
| Technology / Provider | General Purpose | How It Is Used |
|---|---|---|
| Alchemi | AI-assisted preparation of scientific and technical documentation. | Supports BioAgilytix personnel in organizing source information and preparing draft content. BioAgilytix personnel remain responsible for required scientific review, quality activities, approval, and final deliverables. |
| OpenAI (ChatGPT Enterprise) | Enterprise AI platform supporting targeted AI-assisted solutions across scientific, operational, and business workflows. | Supports BioAgilytix personnel in reviewing, organizing, synthesizing, and acting on information within approved workflows. Uses are introduced under applicable security, privacy, quality, data-governance, and human-oversight controls. |
| Microsoft (Microsoft 365 Copilot and related AI tooling) | Enterprise AI capabilities within the Microsoft 365 and broader Microsoft environment. | Supports information synthesis, collaboration, project coordination, documentation, and targeted AI-assisted workflows. BioAgilytix personnel remain accountable for the accuracy, quality, and appropriate use of resulting work products. |
Last updated: August 2026
Is AI Making Scientific Decisions?
AI-assisted technologies may help organize, analyze, draft, summarize, or surface information for review.
They do not independently authorize scientific results, make final quality decisions, approve regulated deliverables, or replace required BioAgilytix scientific, QC, QA, or approval responsibilities.
The level of human oversight applied to a particular capability is based on its intended use and associated risk.
Will AI Replace Existing QC or QA Processes?
Introducing an AI-assisted capability does not, by itself, change established scientific review, QC, QA, or approval requirements.
Any future change to an established control or review process would require appropriate evaluation, approval, and implementation through applicable BioAgilytix quality and governance processes.
How Is Client Information Protected?
Protecting client and study information remains a core requirement when BioAgilytix evaluates or deploys AI-assisted technologies.
Before client information is processed, applicable technologies and providers are subject to appropriate:
- information-security review;
- privacy and data-protection review;
- contractual review;
- third-party/vendor governance; and
- quality or technology governance, where applicable.
The controls applied depend on the nature of the information being processed and the intended use of the technology.
Is Client Information Used to Train Public AI Models?
BioAgilytix does not permit client information to be used to train publicly available or general-purpose AI models for the benefit of other users.
Where a third-party technology provider processes client information on behalf of BioAgilytix, applicable contractual, confidentiality, security, privacy, and data-protection requirements are addressed through our third-party governance processes.
How Are AI-Assisted Technologies Tested and Assured?
The level of testing and documented assurance applied to an AI-assisted capability depends on its intended use, the potential impact of an error, and the controls within the associated process.
Where validation, qualification, testing, monitoring, or other documented assurance activities are appropriate, BioAgilytix applies a risk-based approach consistent with applicable procedures and regulatory requirements.
Will Every BioAgilytix Study Use AI?
No.
Use of a particular AI-assisted capability depends on factors including the applicable service, workflow, technology, contractual requirements, regulatory considerations, and stage of implementation.
Not every AI-assisted technology is applicable to every study or service.
Will BioAgilytix Introduce Additional AI Technologies?
Yes.
BioAgilytix expects its use of AI-assisted technologies to evolve as capabilities mature and additional use cases are evaluated.
Future applications may include additional AI-assisted capabilities that support client services and BioAgilytix operations. Specific technologies and use cases will be introduced through applicable BioAgilytix governance processes.
The technologies and providers supporting these capabilities may evolve over time. New uses remain subject to applicable BioAgilytix security, privacy, contractual, quality, regulatory, and technology-governance requirements.
Does This Change BioAgilytix’s Responsibility for My Study?
No.
BioAgilytix remains responsible and accountable for the services and deliverables we provide, including when AI-assisted technologies support portions of the underlying workflow.
Do I Need to Take Any Action?
No action is required solely as a result of BioAgilytix’s general notification regarding AI-assisted technologies, unless BioAgilytix separately contacts you regarding a requirement specific to your agreement, program, or study.
Questions About a Specific Study or Program
Clients with questions regarding the applicability of an AI-assisted capability to a particular study or program should contact their BioAgilytix representative.