Clinical and AI expertise for your next development decision
Need input on a study concept, AI system, workflow or product? We define the question, assess the available evidence and agree on a specific deliverable. Clinical, technical and regulatory contributions are matched to the project.
We review intended use, clinical relevance, existing evidence and important failure modes. Depending on the agreed scope and available data, the work may include performance, bias and robustness assessment, evaluation planning and review of human oversight.
Outputs may include
An evaluation plan, evidence-gap report or assessment report with prioritised next steps. Validation activities, datasets, evaluation criteria and technical resources are agreed separately.
For clinical development and medical affairs teams, we provide focused input on study concepts, protocols and clinical questions. Formats include protocol or synopsis review, expert consultation and targeted advisory boards.
Outputs may include
Annotated documents, prioritised clinical recommendations or a consolidated report. Subspecialist contributions are confirmed according to the question.
For product teams, healthcare organisations and investors, we examine the clinical problem, intended workflow and proposed product claims. We connect clinical assessment with practical tool-development considerations and the evidence needed for the next decision.
Outputs may include
A decision brief, use-case requirements or a development and evaluation roadmap. Any tool development, integration or deployment is scoped separately, with explicit responsibilities and resources.
Advanced capabilities with explicit project scope.
Qualify AI agents for regulated drug development
We coach, challenge and assess AI agents against defined intended uses and GxP expectations. Each project specifies the system version, decision boundaries, human oversight, test approach and acceptance criteria.
The agreed review can cover
Data integrity and audit trails, validation approach and change control, decision rights, review and override points, accuracy, consistency and source traceability.
Outputs
Qualification plan, challenge test report, oversight model and a readiness decision brief.
1
Coach
Define intended use, role, boundaries and escalation rules.
2
Challenge
Test edge cases, adversarial inputs and failure scenarios; examine reasoning and uncertainty handling.
3
Qualify
Assess reliability, traceability and fitness for the agreed intended use; document findings, limitations and remaining gaps.
Scope and acceptance criteria are agreed before testing. A readiness assessment is limited to the defined use and evidence reviewed; it does not promise regulatory approval.
We examine regulatory questions affecting AI models and agents in drug development and help teams define the evidence, oversight and documentation needed for their intended use. The applicable context, scope and deliverable are agreed for each project.
We are open to co-developing oncology precision medicine and clinical decision support models with partners. Rani Abraham contributes hands-on model-building experience and regulatory innovation expertise. Dr. Mohammed Alfarra contributes clinical expertise, AI education, hands-on tool development and clinical translation. Roles, data access, technical resources, ownership and responsibilities are agreed per project.
Dr. Mohammed Alfarra, Founder & Executive Director, provides strategic direction and brings clinical expertise, AI education and hands-on tool development to project scoping and clinical translation. Rani Abraham, Chief Operating Officer, contributes regulatory innovation, AI validation, agent qualification and model co-development expertise. Project leadership, specialist contributions, availability and conflicts are confirmed before an engagement is accepted.
We can explore scoped tool and model development with suitable collaborators. Hosting, production operation and integration require separate agreement.
Do you deliver entire clinical trials or provide site and patient access?
Our initial focus is scoped specialist work. Trial delivery requires separately confirmed capabilities. Institutional participation, patient access and data access require separate agreements.
