Invite and consent
Eligible patients are invited by their clinician and consent to structured SafeMed follow-up.
Controlled access evidence generation
Real-time safety and evidence for novel medicines.
SafeMed helps pharmaceutical companies and clinical teams offer supervised early access to novel treatments while capturing validated safety, effectiveness, and resource-use evidence in real time.
Validated pharmacovigilance
Clinician-led prescribing
Initial UK focus
100%
structured follow-up expectation for every enrolled patient
No report - No treatment
No treatment is released until the safety protocol is satisfied
What SafeMed is
A controlled access platform for supervised treatment, follow-up, and clinical evidence generation.
SafeMed is a consent-driven pharmacovigilance and follow-up platform for treatments where efficacy is promising but long-term safety, tolerability, real-world effectiveness, or cost-effectiveness evidence is still incomplete.
Patients report on a defined schedule. Adverse events are reviewed by SafeMed pharmacovigilance clinicians and the treating clinician. Prescribing decisions remain with the patient's clinician; SafeMed provides the control, validation, and evidence infrastructure around that decision.
By collecting a numerator (events submitted by patients via follow-up forms) and a denominator (treatment dose and duration), SafeMed generates data on the outcomes of exposure.
The gap
Clinical trials can show efficacy. The uncertainty starts when real-world patients need access.
Rare serious adverse events, long-term safety, effectiveness in usual care, and resource-use evidence often emerge slowly. For orphan drugs, rare, serious, or patients who have exhausted all treatments, waiting years for perfect certainty can also be an ethical problem.
Delayed insight
Conventional post-authorisation studies provide delayed data on effectiveness and adverse outcomes in usual care.
Benefit-risk balance
Whilst efficacy is clear, the lack of safety data is often a barrier to full market authorisation. Continuous data on exposure and outcome with conditional licensing is one possible solution.
Real-world data
Pharmaceutical companies, regulators and payers need high quality effectiveness, exposure, outcomes, toxicity, tolerability, and resource-use data.
The SafeMed model
Controlled supply, continuous follow-up, validated action.
The memorable rule is simple: no report, no treatment. The clinical reality stays nuanced: every reported event is assessed by the SafeMed pharmacovigilance team, while the treating clinician remains in control of prescribing or access.
Capture baseline
Medication, demographics, clinical context, and relevant outcomes are collected before exposure.
Follow up in real time
Patients complete scheduled forms and can report new safety concerns whenever they arise.
Validate events
SafeMed reviews adverse events using structured coding and clinical validation workflows.
Inform decisions
Clinicians receive timely safety context while aggregate evidence supports pharmaceutical companies and regulators.
For pharmaceutical companies
A practical route to generate the evidence conditional pathways need.
- Support controlled access, early access, post-authorisation safety studies, and real-world effectiveness programmes.
- Capture validated exposure, adverse event, outcome, and resource-use data from the start of treatment.
- Build a stronger evidence package for UK conditional marketing authorisation discussions and future reimbursement.
- Deploy a prebuilt platform that can be configured for protocol-specific follow-up and reporting needs.
For regulators and clinicians
Risk management without taking control away from the treating clinician.
- Validated adverse event review, expectedness, relatedness, severity, and decisions on treatment continuation.
- Real-time secure aggregate reporting and anonymised data outputs for oversight and evidence review to assist regulators.
- Clear follow-up requirements that connect treatment continuation to patient safety participation.
- Clinical collaboration model: SafeMed supports, the patient's clinician decides.
System overview
Mobile-first patient follow-up, backed by clinical and regulatory workflows.
SafeMed gives patients a simple reporting experience while creating the structured audit trail needed by clinicians, pharmacovigilance teams, pharmaceutical sponsors, and regulators.
Scheduled and event-triggered follow-up forms
Medication and task readiness tracking
Novel artificial intelligence symptom reporting system with ICD-10 aligned adverse event coding workflows
Two-factor authentication (2FA) and role-based access for clinical and SafeMed team accounts
Confidential ledger-backed audit tables for regulated actions and operational traceability
Electronic signature records with signer identity, timestamp, signature meaning, and payload hash
Optional bring-your-own-key encryption controls for sensitive data environments
Evidence outputs
Designed for the questions sponsors, payers, and regulators ask after access begins.
Safety and tolerability
Continuous adverse event capture, clinical validation, and structured follow-up for every enrolled patient creates adverse event data.
Effectiveness in usual care
Patient-reported outcomes and protocol-specific measures show how treatment performs outside trial conditions.
Resource utilisation
Health-economic evidence can be collected alongside safety and outcome data to contribute to supporting payer conversations.
Operational delivery
SafeMed can contract with research organisations and specialist partners for regulatory, legal, operations, data management, and statistics.
See SafeMed's core features in action.
Watch how the patient follow-up experience, controlled treatment release, and validated safety workflows come together to support supervised access and real-world evidence generation. Contact us at info@getsafemed.com for a full system demonstration.
Our team
Built by pharmacovigilance and regulated healthcare specialists.
CEO
Professor Thomas MacDonald
Emeritus Professor of Clinical Pharmacology and Pharmacoepidemiology, and consultant physician at the University of Dundee School of Medicine at Ninewells Hospital, with decades of leadership in drug safety, clinical trials, pharmacoepidemiology, and real-world medicines evidence. Professor MacDonald established and led MEMO Research, co-chaired ENCePP, and has served as past President of both ISPE and BIHS, and is a fellow of the Faculty of Pharmaceutical Medicine. At SafeMed, this clinical and regulatory experience drives the vision for a platform that makes medicine monitoring more proactive, scalable, and reliable by generating data.
CTO
Kris Zutis
A research and technology background spanning clinical trial software, medical image analysis, signal processing, machine learning, and applied AI. Over 10 years at MEMO Research, work alongside Professor MacDonald included leading the development of clinical trial software used by thousands of participants, with a focus on study workflows, data capture, and safety monitoring. At SafeMed, this experience has shaped the platform from the ground up, turning complex medicine safety workflows into robust, secure, and usable software.
Start the conversation
Have a promising medicine that needs a safer route into real-world use?
Talk to SafeMed about early access, validated follow-up, and the real-world evidence package needed for confident regulatory and clinical decisions.