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Clinical Trial Disclosures

Clinical Trial Disclosures can be daunting, but I have extensive experience with navigating and writing them, so I can help you achieve full compliance in whatever is necessary. 

Clinical Trial Disclosure

I have extensive experience in clinical trial disclosure, having successfully registered and posted results from hundreds of trials to platforms such as ClinicalTrials.gov and EudraCT. I ensure your trial data is transparently and compliantly shared.

Redactions

My expertise includes managing the preparation of thousands of documents for redaction, including successful execution of over 50 Policy 0070 submissions. I can help you achieve full compliance and meticulously protect sensitive data within your disclosures.

Plain Language Summaries

I specialize in developing clear and accessible plain language summaries, translating complex scientific information for diverse audiences. Additionally, I can assist in developing plain language style guides tailored to your needs, ensuring consistency and clarity across all your studies and communications.

Why are medical writers important?

Deeper Knowledge

Medical writers play a crucial role, from breaking down complex scientific research for regulatory agencies to helping biopharma and health companies engage their audiences. As a physician, I offer a unique clinical perspective, ensuring your content not only meets these standards but also deeply understands and reflects the realities of patient care and medical practice.

Faster Time-To-Write

While no one possesses universal knowledge, medical writers - especially physician writers - excel at rapidly assimilating new therapeutic areas, complex concepts, and specialized terminology. In the fast-paced biopharmaceutical and medical device industries, this agility is invaluable, empowering companies to remain at the forefront of innovation.

Multiple Skillsets

Beyond core scientific knowledge, writing proficiency, and project management, a highly effective medical writer often possesses a unique skill that enhances outcomes—be it biostatistics expertise or specialized publication management. For your projects, I add to this foundation with my unique physician's perspective, proven statistical analysis acumen, and a strategic understanding of digital content, copywriting, and SEO to maximize your impact.

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