Clinical Transparency & Disclosure

Best Practices for Writing Clinical Study Protocols

Kelley Kendle

The pharmaceutical industry has long grappled with the problem of poorly written clinical study protocols. The study protocol describes the conduct of a study, its objectives, methodology, design, and statistical considerations and ensures the safety of participants and integrity of data collected. The teams generally responsible for protocol writing are the medical writing and regulatory […]

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Topics: Clinical Transparency & Disclosure, Regulatory & Medical Writing

Certara’s Best of Blogs 2015

A selection of short essays from our blog, written to empower our customers with biosimulation and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing.

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Do the Right Thing: Ethical Mandates for Clinical Trial Transparency

Kelley Kendle

The history of biomedical research in the United States has long been plagued with ethical problems. Writer Rebecca Skloot details a famous example of this history in her book, “The Immortal Life of Henrietta Lacks.” The non-fiction work recounts the origin of the HeLa cells—derived from the tumor of a Baltimore woman named Henrietta Lacks. […]

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Topics: Clinical Transparency & Disclosure, Regulatory & Medical Writing

Strategic Regulatory Writing for Drug Development Success

Kelley Kendle

Happy New Year! The start of a new year brings the promise of new opportunities for growth—both personally and professionally. As the CEO for Synchrogenix, Certara’s regulatory writing consultancy, I’ve been thinking a lot lately about how changes in the regulatory writing landscape will shape the drug development process in 2015. It’s becoming more and more […]

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Topics: Clinical Transparency & Disclosure, Regulatory & Medical Writing
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