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AI Won’t Replace Writers, But Writers Who Use AI Will Outpace The Rest with Bilal Bham
Manage episode 522518207 series 3526489
What if the documents behind a clinical trial were written with the patient’s voice in mind and delivered at the speed modern science deserves? We sit down with writer, consultant, and patient-advocate Bilal Bham to unpack how protocols, clinical trial applications, and clinical study reports actually get made, why structure beats chaos, and where AI genuinely shortens timelines without cutting corners. From first protocol outlines to final submissions, Bilal shares a process that blends proprietary AI with rigorous human review to turn dense source data into clear, regulator-ready narratives.
The conversation gets real about the craft. Bilal argues that new writers still need to learn documents end-to-end: where to find truth in source files, how to build arguments across sections, and how to keep stakeholders aligned from biostats to clinical operations. AI helps when you feed it the right ingredients, starting with comprehensive bullet-pointed outlines rather than instant prose. That discipline shaves weeks off delivery and keeps quality high, especially when regulators are exploring AI on their side of the table and expect traceability, accuracy, and transparent logic.
We also explore the power of inclusion. Living with Graves’ disease and thyroid eye disease, Bilal explains how patient experience sharpens trial design, consent language, and symptom reporting. Diversity is not a banner; it is better science. Recruiting across local communities in the UK, US, and Europe strengthens external validity and reveals gene-environment differences that change safety and efficacy. Pair that with plain-English patient summaries, fair compensation, and trusted community partners, and you get trials that are faster to run, easier to understand, and more likely to help the people who need them most.
If you care about clinical trials, regulatory writing, medical communications, AI in pharma, and building inclusive studies that actually work in the real world, this conversation is for you. Subscribe, share with a colleague, and leave a review with your take: where should inclusion start in clinical research?
Transformation in Trials is a podcast investigating how we can change life sciences to get treatment to patients faster.
I have been independently producing this episode since 2021. You can now support the show by Buying Us a Coffee. Each episode costs 99USD/ 85 EUR to produce.
Join the show as a guest - apply via this Form.
________
Reach out to Ivanna Rosendal
Join the conversation on our LinkedIn page
Chapters
1. AI Won’t Replace Writers, But Writers Who Use AI Will Outpace The Rest with Bilal Bham (00:00:00)
2. Framing The Patient-Advocacy Lens (00:01:03)
3. What Regulatory Writers Actually Do (00:02:36)
4. Breaking Into Medical Writing (00:05:28)
5. How AI Changes The Writing Workflow (00:08:19)
6. Training, Skills, And Limits Of AI (00:12:41)
7. Build-Out: Proprietary AI And Process (00:16:51)
8. Sponsor Investment, Speed, And Cost (00:21:06)
86 episodes
Manage episode 522518207 series 3526489
What if the documents behind a clinical trial were written with the patient’s voice in mind and delivered at the speed modern science deserves? We sit down with writer, consultant, and patient-advocate Bilal Bham to unpack how protocols, clinical trial applications, and clinical study reports actually get made, why structure beats chaos, and where AI genuinely shortens timelines without cutting corners. From first protocol outlines to final submissions, Bilal shares a process that blends proprietary AI with rigorous human review to turn dense source data into clear, regulator-ready narratives.
The conversation gets real about the craft. Bilal argues that new writers still need to learn documents end-to-end: where to find truth in source files, how to build arguments across sections, and how to keep stakeholders aligned from biostats to clinical operations. AI helps when you feed it the right ingredients, starting with comprehensive bullet-pointed outlines rather than instant prose. That discipline shaves weeks off delivery and keeps quality high, especially when regulators are exploring AI on their side of the table and expect traceability, accuracy, and transparent logic.
We also explore the power of inclusion. Living with Graves’ disease and thyroid eye disease, Bilal explains how patient experience sharpens trial design, consent language, and symptom reporting. Diversity is not a banner; it is better science. Recruiting across local communities in the UK, US, and Europe strengthens external validity and reveals gene-environment differences that change safety and efficacy. Pair that with plain-English patient summaries, fair compensation, and trusted community partners, and you get trials that are faster to run, easier to understand, and more likely to help the people who need them most.
If you care about clinical trials, regulatory writing, medical communications, AI in pharma, and building inclusive studies that actually work in the real world, this conversation is for you. Subscribe, share with a colleague, and leave a review with your take: where should inclusion start in clinical research?
Transformation in Trials is a podcast investigating how we can change life sciences to get treatment to patients faster.
I have been independently producing this episode since 2021. You can now support the show by Buying Us a Coffee. Each episode costs 99USD/ 85 EUR to produce.
Join the show as a guest - apply via this Form.
________
Reach out to Ivanna Rosendal
Join the conversation on our LinkedIn page
Chapters
1. AI Won’t Replace Writers, But Writers Who Use AI Will Outpace The Rest with Bilal Bham (00:00:00)
2. Framing The Patient-Advocacy Lens (00:01:03)
3. What Regulatory Writers Actually Do (00:02:36)
4. Breaking Into Medical Writing (00:05:28)
5. How AI Changes The Writing Workflow (00:08:19)
6. Training, Skills, And Limits Of AI (00:12:41)
7. Build-Out: Proprietary AI And Process (00:16:51)
8. Sponsor Investment, Speed, And Cost (00:21:06)
86 episodes
All episodes
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