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 Even minor, avoidable issues (missing annexes, outdated guidance, inconsistent documents) can postpone study start by weeks or months.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 ...

What is  Quality by Design  according to ICH GCP E6(R3)?  E6(R3) Good Clinical Practice (GCP) places Quality by Design as a a key and recurring principle across the guideline. The concept is introduced in the context of clinical study design, risk identification, and planning , and is reinforced at multiple points throughout the document as follows:

FDA warning letters are most often associated with manufacturing or product-related issues, but they can also be issued directly to clinical investigators when significant regulatory concerns are identified during inspections.  These letters are typically issued months after the underlying events , following: an on-site inspection, documented observations, and review of written responses provided by the investigator or site. As a result, a warning letter may appear long after the clinical activity in question has already concluded. Here are 2 examples from December 2025: Example 1  -  https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/purushothaman-damodara-kumaran-md-721325-12222025 Example 2 - https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/devalingam-mahalingam-md-phd-721145-12112025 What such letters generally indicate

Guiding Principles of Good AI Practice in Drug Development, January 2026  ( https://www.fda.gov/media/189581/download ) In January 2026, the U.S. Food and Drug Administration , together with international regulatory partners, published ten principles for Good AI Practice in Drug Development : Human-centric by design Risk-based approach Adherence to standards Clear context of use Multidisciplinary expertise Data governance and documentation Model design and development practices Risk-based performance assessment Life cycle management Clear, essential information These principles are presented as a foundation for further work rather than a finalized implementation framework. They describe what regulators consider important when AI is used to generate evidence across the drug product life cycle, without defining how these expectations should be met in specific technical or organizational settings. At this stage, the document is intentional...

According to remarks reported by the Regulatory Affairs Professionals Society, the FDA Center for Drug Evaluation and Research (CDER) issued 50% more warning letters in fiscal year 2025 than in the previous year. This is a notable increase and suggests a change in enforcement activity that warrants closer examination. Whether this reflects a shift in regulatory posture, changes in industry behavior, or increased scrutiny of emerging areas remains an open question. Rather than treating this figure purely as a headline about enforcement intensity, it is useful to consider what such an increase may indicate about where regulatory attention is currently focused and how oversight adapts as technologies, business models, and supply chains evolve. Enforcement volume as a signal, not just an outcome Warning letters are often viewed as the final step in regulatory enforcement. From a systems perspective, they can also be understood as lagging indicators . By the time a warning ...

Clinical research software is often associated with large, enterprise platforms. Alongside these established systems, however, a growing group of specialized and innovation-focused solutions addresses specific pain points such as protocol planning, budgeting, recruitment, operational oversight, and documentation. These tools are frequently adopted as complements to core systems rather than replacements, particularly in regulated environments. This overview highlights selected software providers that are commonly referenced in discussions about digital transformation in clinical research , with a focus on planning, feasibility, budgeting, and operational coordination. Protocol Design, Planning, Budgeting and Feasibility Espero Health  (Sweden) develops software focused on protocol-driven budgeting and feasibility assessment in clinical research. The platform emphasizes deriving cost and effort estimates directly from structured protocol activities and Schedule of Event...

FDA warning letters are publicly available and can be read in full. They are one of the most transparent regulatory resources for understanding how quality and compliance issues are identified and described by regulators. Official FDA Warning Letter Repository All FDA warning letters are published on the official FDA website: 👉 FDA Warning Letters Database https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters This repository is maintained by the U.S. Food and Drug Administration and is updated regularly. How the repository is structured On the FDA warning letters page, you can: Browse warning letters by year Filter by FDA center (e.g. drugs, biologics, devices) Search by company name Search by subject or keyword Each entry links to a PDF or HTML letter issued directly by the FDA. What to look for when reading a warning letter For educational purposes, it is useful to read warning letters systema...

What recent publications and reports are pointing to. Evidence and open questions. Clinical trials are essential for evaluating the safety and efficacy of new therapies, but the operational and financial burden of modern trials has grown significantly over recent decades. Trials are becoming more complex, expensive, and difficult to execute. These often require elaborated protocol designs, extensive regulatory documentation, and multi-site coordination. All of which contribute to longer timelines and higher costs. Recent analyst commentary on the clinical trials industry highlights complexity as a core challenge limiting feasibility . https://www.clinicaltrialsarena.com/features/clinical-trials-challenges-expect-2025 At the same time, funding disruptions have had measurable impacts on clinical research feasibility. A study published in JAMA Internal Medicine reported that NIH grant terminations disrupted approximately 3.5 % of active federally funded clinical trials, a...

Blogging in 2026 looks questionable. Most people no longer read blogs and long posts. Information is searched, skimmed, or delegated to generative AI. Even thoughtful posts may attract little attention, while AI can generate fluent text instantly. Against this background, blogging no longer functions reliably as a communication channel. The relevant question is therefore not how to grow a blog, but whether blogging still serves a meaningful purpose. One answer is epistemic. Blogging has increasingly become a way of documenting reasoning rather than broadcasting information. Generative AI produces language at scale, but it does not assess novelty, truth, or justification. It optimizes for plausibility, not for being right for the right reasons. When humans write carefully, make assumptions explicit, and acknowledge uncertainty, they leave traces of reasoning that are qualitatively different from synthetic text. Blogging, in this sense, preserves human judgment in public form...