Tim Hardman
@tim-hardman.bsky.social
Dr Tim Hardman is the Founder and Managing Director of Niche Science & Technology Ltd., a bespoke UK-based CRO he established in 1998. Tim has more than 40 years of experience in clinical research.
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
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
February 12, 2026 at 1:36 PM
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
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
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
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
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.
niche.org.uk
February 12, 2026 at 12:50 PM
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
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
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...
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...
www.linkedin.com
February 11, 2026 at 5:38 PM
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...
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...
Editing tip: Size is important - Niche - Clinical Research Organisation | Niche Science & Technology
Writing that is short is vigorous.
niche.org.uk
February 11, 2026 at 5:32 PM
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 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...
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
niche.org.uk
February 11, 2026 at 3:06 PM
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: 🚀 The Year Your Cells Got Smarter, Your Gut Got Chatty, and AI Learned to Explain Itself. www.linkedin.com/pulse/2025-r...
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...
www.linkedin.com
February 11, 2026 at 8:58 AM
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...
📢 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
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.
niche.org.uk
February 11, 2026 at 8:51 AM
📢 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
February 11, 2026 at 8:49 AM
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
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...
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...
link.springer.com
February 9, 2026 at 7:05 PM
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...
link.springer.com/article/10.1...
link.springer.com
February 9, 2026 at 7:04 PM
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...
link.springer.com/article/10.1...