Welcome to the Medical Valley network, Lucie – Trusted Trials!
We are pleased to welcome Lucie – Trusted Trials as the newest member of our network. Lucie – Trusted Trials is an end-to-end software platform for electronic data capture, uniting electronic Patient Informed Consent, electronic Patient Questionnaires and electronic data capture in a single integrated environment – designed specifically for organisations conducting clinical studies such as post-market studies.
In an interview with Dr. Dominik Lysek, CEO of Lucie by PharmaTrail AG, we gain further insights into the company.
What is “Lucie – Trusted Trials,” what services does it offer, and how do sponsors and research teams benefit from it?
Lucie is an end-to-end Electronic Data Capture (EDC) software platform built for organisations conducting clinical investigations like post-market studies. The platform combines electronic consent (eConsent), electronic patient questionnaires (ePRO), electronic data capture, study manager, real-time dashboards, and data export and archival in a single, integrated environment.
What sets Lucie apart is that it is the only EDC platform to anchor clinical data to an immutable private blockchain. Every data entry is cryptographically timestamped and hashed to a structurally separate ledger – meaning the audit trail cannot be altered by any user, including administrators. This moves data integrity from assertion to proof. For sponsors, this translates directly into inspection readiness, reduced risk of regulatory rejection, and stronger confidence in submitted findings. For research teams, it means a tamper-evident record from the first patient through database lock without adding complexity to day-to-day workflows.
For sponsors and research teams, the practical value of this is significant. Tamper-proof audit trails reduce the likelihood of regulatory rejection, shorten due diligence timelines for investors, and increase the company’s sale valuation because repetitive trials are not needed to reconfirm the product’s efficacy.
In a world where trust in data is increasingly scrutinised, immutable records mean that findings can be independently verified because they reflect exactly what occurred.
How does your platform specifically support small and medium-sized enterprises in conducting clinical studies, and what benefits are seen in practice?
For small and mid-size organisations, the most immediate benefit Lucie offers is simplicity. The study setup is fast and intuitive – full configuration in two weeks and site onboarding is streamlined with roles, permissions, and training materials ready out of the box. The interface is designed to minimise site training and support for typical tasks. When sites can work confidently and independently, the workload on study managers drops significantly – which is why our internal motto is “Happy Sites, Happy Life”.
Built-in compliance is the second major advantage. Audit trail management, role and permission frameworks, and plausibility checks are pre-configured to meet regulatory requirements. Studies can be supervised by a small team – even one without daily experience in clinical systems – without sacrificing data quality or regulatory rigour. This is particularly valuable for medical device manufacturers working toward MDR approval, where verified data integrity strengthens clinician confidence and advocacy, leading to faster market adoption.
In practice, one of our clients, a first-time sponsor in Germany with no prior experience in clinical trial operations, was able to design, configure, and launch their first study with our support – and then went on to independently run subsequent trials, applying what they had learnt. That transition from guided support to independent ownership is exactly what the platform is designed to enable.
How does Lucie ensure the quality and regulatory compliance of study data, and what role does the “Data Integrity by Design” approach play in this?
Lucie and its underlying blockchain framework is built to meet the compliance requirements of clinical investigations from the ground up. The platform is aligned with EU MDR 2017/745 and FDA 21 CFR Part 11, privacy-by-design for GDPR and HIPAA, EU Annex 11, and ISO 14155 (GCP). This means organisations are not retrofitting compliance onto a general-purpose system – the regulatory framework is embedded in how the platform works.
The foundation for data quality in clinical research is the ALCOA++ principle: data must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available. These are not just process expectations – they are what regulators look for during inspections, and what auditors need to verify. Lucie is specifically designed to make each of these attributes independently demonstrable, not merely asserted.
This is where the blockchain integrity layer matters. Rather than relying on an audit trail that lives inside the same database it is meant to protect, Lucie anchors every data event to a structurally separate, tamper-evident ledger. If any record is altered after the fact, it is immediately detectable. No patient identifiable data is ever stored on-chain – only cryptographic fingerprints – so privacy requirements are met by design. The practical result is that sponsors and auditors can verify data integrity directly, without having to take the system’s word for it. For organisations preparing for regulatory submissions or inspections, that difference is significant.
Which functions or workflows contribute most to making data collection more efficient and less error-prone?
Our motto is “Happy Sites, Happy Life” and we mean it practically. If sites can use the platform easily, the workload of study managers drops significantly. Every design decision points toward simplicity and the minimum number of clicks.
eCRFs in Lucie are dynamically structured: fields that are not relevant to a specific patient situation do not appear at all. This is grounded in real clinical workflows and eliminates a meaningful source of error – data entered in the wrong context, or fields left blank because they did not apply. Automatic validations run as data is entered: if a value falls outside a defined range, the site receives an immediate notification rather than a manual query weeks later. This prevents correction loops and keeps data consistent throughout the study.
Role-based task overviews consolidate everything that is open – pending visits, missing data, monitoring questions – in one place. For teams that do not work with study management every day, this creates orientation and reduces the risk that tasks fall through the gaps. For decentralised or hybrid studies, mobile input options allow data to be captured directly in clinical practice and flow into the study without transmission errors.
The platform’s development team has deep operational experience in monitoring, study management, and data management. Many features trace directly to situations we have encountered in the field – which is why they tend to fit real workflows rather than requiring users to adapt their work to the software.
Your platform is used in multiple countries. What experiences have you gained from international projects, and how are these insights incorporated into the further development of Lucie?
Lucie has been deployed across studies in Europe and the United States, spanning medical device investigations, post-market surveillance registries, and randomised controlled trials in sectors including dentistry, cosmetic medicine, and broader MedTech. International projects have taught us things that domestic deployments simply do not surface.
One lesson that has consistently shaped the platform is the importance of language-independent usability. In international studies, English is rarely the first language of every investigator or site coordinator. If a platform requires users to interpret ambiguous instructions or navigate a complex interface under time pressure, errors follow. This has driven our commitment to clear, simple user interface design – the kind that allows a site to begin enrolling patients within 24 hours of activation, regardless of where they are based. The same principle applies to patient-reported outcomes: because our team came from the clinical trial industry, we understood early on that ePROs need to be available in the patient’s own language to capture the most accurate data. Lucie supports multilingual ePRO delivery as a standard capability.
International experience has also shaped how we handle data protection and storage requirements. Some jurisdictions require local data storage or specific access controls. Lucie is built as a flexible platform where configurations can be adapted to meet local requirements without compromising the integrity or consistency of the overall study. Working across time zones has further reinforced the value of asynchronous monitoring and review functions – teams can see at any time what has been completed and where action is still needed, independent of when or where they are working.
As a member of Medical Valley, what opportunities do you see for cooperation, knowledge exchange, or joint projects with other MedTech companies?
Medical Valley brings together precisely the ecosystem that matters for what Lucie does – medical device developers, clinical research organisations, technology providers, and academic institutions working in proximity. That combination creates real collaboration opportunities rather than generic networking.
The most natural area of collaboration is with small and mid-size MedTech companies at an early stage of their clinical evidence journey. Many of these organisations have strong device development capabilities but limited experience with the operational and regulatory requirements of structured clinical investigations. Lucie can serve as both platform and practical partner in that transition – and the Medical Valley network is a way to make those connections early, before companies have committed to approaches that may not serve them well at scale.
We also see value in knowledge exchange around data integrity and regulatory preparedness. The EU MDR clinical evidence requirements are a significant operational challenge for many device manufacturers, and the standards around data governance – ALCOA+, Annex 11, E6(R3) – are evolving. Sharing practical experience across the network on what inspection-ready data infrastructure looks like in real studies is valuable in both directions.
Finally, there is an opportunity for collaborative model development with CROs and clinical consultancies operating within the network. Lucie is designed to work alongside CRO partners – combining operational execution with platform-level data integrity – and building those relationships within a structured ecosystem like Medical Valley is something we are actively interested in.