Tim Hardman

AI generates text — but it doesn’t understand nuance, risk, or the ethical weight of data. In regulated environments, precision and accountability aren’t optional. Writing is thinking. AI can assist — it can’t replace. Are you reviewing rigorously?
🔗 lnkd.in/ePbKRR5h

The Evolution of Patient Voice - Niche - Clinical Research Organisation | Niche Science & Technology For much of the twentieth century, patients in clinical research were positioned primarily as subjects of experimentation rather than active partners

A recent Niche post on patient-reported outcomes sparked a wider debate on what we really mean by patient voice. It reminded me of a 2023 blog inspired by our RASP-UK program patient platform — where patient voice wasn’t a checkbox, it’s was architecture.
niche.org.uk/ptvoice

AI: Solving a Problem That Doesn’t Exist The implication that medical writers represent a bottleneck ripe for elimination is misplaced.

Everyone’s bowing to AI in clinical writing—but what if the Emperor has no clothes? This article exposes the myth, the hype, and the real reason CSRs take time. If you work in pharma, you need to read this. 👉 “AI: Solving a Problem That Doesn’t Exist” niche.org.uk/aicsrprob

The Enduring Problem of Under-Reporting of Clinical Trials When trial findings are not reported the resulting gaps in the scientific record distort evidence synthesis, misdirect clinical decision-making, and erode public trust in research.

Writing is hard but when trial findings are not reported the resulting gaps in the scientific record distort evidence synthesis, misdirect clinical decision-making, and erode public trust in research. Read on: niche.org.uk/undercsr

Medical Writing 2026: Adapting to AI and Rising Complexity | Niche Discover how artificial intelligence, economic pressure, and regulation are transforming medical writing, and what this means for quality and accountability.

Is 2026 an “axis year” for medical writing? AI, cost pressure, regulatory complexity, and geopolitics may be reshaping the profession faster than we realise. A timely reflection on what’s changing—and what still matters. niche.org.uk/medical-writ...

Typefaces, Fonts and Features | Niche Is your font choice affecting your message? Explore the communicative power of typography in medical writing and how deliberate design enhances clarity and professionalism.

Would the same scientific statement feel more believable in a different font? Typography quietly influences credibility, cognition, and clarity. This piece explains how — and why it matters. niche.org.uk/typeface

The Future of Drug Development: Data, AI, and Clinical Trials by 2050 | Niche - Science & Technology Learn how data, AI, and real-world evidence are transforming drug development and clinical trials, and what the pharma industry could look like by 2050.

In 2022, we tried to predict the future of drug development. Then AI exploded, venture funding cooled, regulation shifted, and Asia accelerated and still 25 years still to run to 2050. niche.org.uk/future-drug-...

Write Like an AI | Niche - Science & Technology Is writing just word optimization? Compare the smooth, predictable patterns of AI-generated text with the stylistic risks of human medical writing.

If your writing is flawless, predictable, and perfectly structured… it might already look like it was written by AI. Explore why that’s a problem — and what genuinely human writing still does better (imho). What do you think? niche.org.uk/writeai

Love, Leadership, and Life Sciences | Niche Beyond the Valentine's metaphor: Explore the neurochemistry of love, from dopaminergic circuits to oxytocin-mediated bonding and immune regulation.

Valentine’s Day meets life sciences 💘🔬
Love isn’t metaphor — it’s measurable biology. From dopamine circuits to digital biomarkers, emotional states are becoming drug-targetable, AI-quantified, and commercially strategic. niche.org.uk/love2-2

Our MD is part of the ICR 2026 Scientific Programme Committee lnkd.in/egg3fi22

CSRs used to be 30 pages. Now the synopsis can be 20+. Trial complexity is up. Risk aversion means everything stays in.

But longer ≠ better.

Concise, focused reports help regulators, patients & approvals. Lean CSR writing isn’t cutting corners it’s cutting clutter. 👇 niche.org.uk/increasingcsr

Estimand Framework in Clinical Trials | Niche Learn how the estimand framework improves clarity in clinical trials, how intercurrent events are handled, and why ICH E9 (R1) matters for regulators.

40 years of regulatory submissions. Same gold-standard document.

Now some want to rename it. Change without endorsement isn’t modernisation. It’s semantics.

Patients need better summaries, not rebranded appendices.

Substance > semantics. 📄

👇 Read why niche.org.uk/ctrcsr

MS Outlook: Between Mastery and Servitude For many of us, Microsoft Outlook has become not just an application but an organising principle for life. Its omnipresence in corporate environments makes it the de facto interface through which we m...

Feeling like you manage a team, but your inbox manages you? Outlook is meant to empower us, but has it instead turned us into reactive responders, outsourcing our memory, judgment, and even leadership to an app? Do you know how you will take back control? www.linkedin.com/pulse/ms-out...

Editing tip: Size is important - Niche - Clinical Research Organisation | Niche Science & Technology Writing that is short is vigorous.

As writers we know that sentence length shapes how readers move through a text: it controls pace, emphasis, and, crucially, whether people keep reading. Short sentences pull us forward. Longer ones invite reflection. niche.org.uk/size-is-impo...

Efficient Document Editing: A three-phase workflow - Niche - Clinical Research Organisation | Niche Science & Technology You can waste a considerable amount of time when reviewing and editing

Efficient document editing using a three-phase workflow. Written long before large language models began offering instant rewrites and automated suggestions (in 2012), this article sets out a thoughtful, disciplined approach to editing and its value niche.org.uk/manuscript-e...

2025 in Review: Ten Medical Breakthroughs Last year was another remarkable chapter in biomedical science. From discoveries that could reshape how we treat chronic disease to innovations that edge us closer to personalised medicine and regener...

2025 in Review: Ten Medical Breakthroughs: 🚀 The Year Your Cells Got Smarter, Your Gut Got Chatty, and AI Learned to Explain Itself. www.linkedin.com/pulse/2025-r...

The Growing Role of Patient-Reported Outcomes in Clinical Study Reports - Niche - Clinical Research Organisation | Niche Science & Technology Explore the growing role of patient-reported outcomes in clinical trials and how they inform clinical study reports for regulatory and research impact.

📢 Patient Voice Matters — Even in Your Clinical Study Report. We’ve all focused on endpoints, biomarkers and safety signals — but are we truly capturing what matters most to patients? 🧠👩‍⚕️Read the full article here: niche.org.uk/proscsr

We recently released the newest version of our Insider’s Insight on Clinical Study Reports. It’s rewarding to see a resource that started as practical guidance continue to evolve alongside the industry and remain genuinely useful. Sign up for your copy: lnkd.in/esRxkD2X

Healthcare professionals’ perspective on treatment burden and patient capacity in low-income rural populations: challenges and opportunities - BMC Primary Care Background The challenges of chronic disease self-management in multimorbidity are well-known. Shippee’s Cumulative Complexity Model provides useful insights on burden and capacity factors affecting h...

Rural providers struggle to balance care with systemic poverty. This study explores how financial stress and limited resources overwhelm patient capacity. A vital look at the gap between clinical demands and rural poverty.#RuralHealth #HealthEquity #PrimaryCare link.springer.com/article/10.1...

Rural providers struggle to balance care with systemic poverty. This study explores how financial stress and limited resources overwhelm patient capacity. A vital look at the gap between clinical demands and rural poverty.#RuralHealth #HealthEquity #PrimaryCare

link.springer.com/article/10.1...