Clinical Research & Clinical Trial Management | Project Owner

Is cross-system clinical trial automation failing not because workflows cannot be executed, but because protocol terminology cannot be interpreted consistently across systems and clinical studies? Discussions about automating clinical trials often focus on advanced technologies such as workflow engines, interoperability standards, and AI/ML. In practice, cross-system automation most often breaks much earlier, at a far more basic level: inconsistent naming conventions .  Clinical protocols are written in natural language, where the same term can legitimately carry different meanings depending on study design, therapeutic area, or regulatory intent. Software systems, by contrast, assume that identifiers are stable, explicit, and unambiguous. This mismatch creates friction long before questions of execution logic or governance arise. Several academic and industry initiatives have proposed encoding protocol elements, such as eligibility criteria, visits, milestones, consen...

Why promising concepts have not translated into practical implementation? Lessons Learned. The idea of using blockchain to automate clinical trials emerged from a compelling analogy: if financial contracts can be expressed as executable smart contracts, why not clinical protocols? 

Platforms, GenAI, and modular services. How can this impact Project Management?  Work organization is evolving across many knowledge-intensive industries. Digital platforms, GenAI-assisted production, and global access to qualified specialists are changing how services are offered, priced, and evaluated . This development is visible even in domains traditionally characterized by strong regulation and institutional structures, like clinical research. Rather than asking whether regulated projects are “moving” to open platforms, a more precise question is:

Clinical trial timelines in Switzerland are tightly linked to the efficiency of submissions to Swissmedic . Delays at this stage do not remain confined to regulatory milestones. They cascade into site activation, contracts, budgets, and overall project duration . From a project-management perspective, Swissmedic approval is frequently on the critical path . Even minor, avoidable issues (missing annexes, outdated guidance, inconsistent documents) can postpone study start by weeks or months.

What changes if we consider life as a project? Projects fail rarely because of one catastrophic event. They fail because small deviations accumulate , risks go unnoticed, and performance is not tracked against expectations. Aging may follow a similar pattern. Instead of asking “How do we defeat aging?” , we can ask a different question: What if we consider life as a long-running project, and manage it using basic project control logic? This reframing does not promise immortality. It proposes something more modest and potentially more useful: governance of healthspan over time . Project management analogy: Planned, Actual, and Longevity Value

Advances in mobile technology have opened new pathways for clinical research that go beyond traditional site-centric models. Mobile apps now play a growing role in study visibility, participant engagement, and data collection , both within regulated clinical trials and in healthy-population research. Rather than replacing clinical trial systems, these platforms operate at a different layer: they connect people to research , standardise how participation occurs, and enable more continuous, real-world data capture. Over time, this may support more structured datasets, easier study access, and more reliable evidence for analysis and decision-making. Below are two groups of mobile platforms illustrating this shift. Mobile Platforms Supporting Clinical Trial Participation (Patient-facing, trial-specific apps) Science 37 — Studies App Focus: Decentralized and hybrid clinical trials Science 37’s Studies App allows participants to discover, consent to, and take part in clinica...

One trial, one purpose or many stakeholder perspectives? The expression “fit for purpose” appears 14 times in ** ICH GCP ICH E6(R3) . This repetition is not accidental. It signals a deliberate regulatory shift away from rigid, one-size-fits-all compliance toward a more contextual, risk-based understanding of quality, proportionality, and oversight in clinical research. At the same time, the phrase itself is deceptively simple. According to the Cambridge Dictionary , fit for purpose means: “Suitable and good enough to do what it is intended to do.” Fit for Purpose in ICH GCP (R3) Within ICH GCP E6(R3) , fit for purpose is used to describe a wide range of elements, including trial processes, quality management systems, oversight mechanisms, data handling approaches, and supporting technologies. Across all these contexts, the underlying principle is consistent: systems and processes should be appropriate for their intended use , proportionate to risk, and focused on ...