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Achieving Compliance with the FDA’s eCTD Mandate

The US Food and Drug Administration (FDA) has set May 5, 2018 as the compliance date for submitting many types of files—Drug Master File (DMFs) and commercial investigational new drugs (INDs)—in the electronic Common Technical Document (eCTD) format. A DMF provides confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, […]

Author(s): Rob Labriola
Solution: Regulatory & Medical Writing
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New FDA Commissioner Endorses Use of M&S to Advance Drug Development

With the swearing in of Dr. Scott Gottlieb as Commissioner of Food and Drugs in May, many have wondered as to the climate he will set for the US FDA. Certara’s mission and business thesis aligns with the FDA’s July 7 announcement regarding the steps it is taking to implement the 21st Century Cures Act. […]

Author(s): Suzanne Minton
Solution: Clinical Transparency & Disclosure, Model-based Meta-analysis, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing
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Best Practices for a Successful eCTD Submission

The eCTD struggle is real. Regulatory submissions must conform to the electronic common technical document (eCTD) format to be successfully received and reviewed by health authorities. And while this might seem simple, this complex technical process is actually rife with risk if you lack expertise in medical writing and regulatory publishing. In this blog post, […]

Author(s): Rob Connelly
Solution: Regulatory & Medical Writing
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Best Practices for Writing Clinical Study Protocols

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 […]

Author(s): Kelly Kendle
Solution: Clinical Transparency & Disclosure, Regulatory & Medical Writing
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Avoiding Pitfalls in Plain Language Summaries of Clinical Trial Results

Building trust with clinical trial participants is critical to the success of drug development programs. One of the best ways to earn that trust is by meeting their expectations regarding learning study results. In fact, a 2015 study by the Center for Information and Study of Clinical Research Participation (CISCRP) showed that 73% of clinical […]

Author(s): Behtash Bahador
Solution: Clinical Transparency & Disclosure, Regulatory & Medical Writing
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Avoiding Pitfalls in Plain Language Summaries of Clinical Trial Results

In this webinar, Tatyana Wanderer and Behtash Bahador provided insights and recommendations gained from working with leading sponsors on portfolio-wide implementation and pilot programs to create plain language summaries of clinical trial results.

Speaker(s): Tatyana Wanderer, Behtash Bahador
Solution: Clinical Transparency & Disclosure, Regulatory & Medical Writing
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How AI Tech Is Changing Regulatory Writing

Did you know that you’re likely using artificial intelligence (AI) in your everyday life? For example, the digital music service, Spotify, creates “mood-based” playlists that are curated to users’ musical preferences. Spotify generates these customized play lists using a machine learning algorithm that has learned your unique musical preferences based on your previous interactions with […]

Author(s): Nirpal Virdee
Solution: Clinical Transparency & Disclosure, Regulatory & Medical Writing
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