The Certara Blog: Clinical Transparency & Disclosure

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. […]

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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 […]

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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 […]

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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 […]

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EMA Policy 0070 Compliance Tips from James Bond

In many ways, the strategic planning required to comply with EMA Policy 0070―a requirement to publish anonymized versions of clinical study reports (CSRs) and other submission documents―is similar to a secret agent’s mission: sponsors must keep the identities of people named or referred to in those documents top-secret while maintaining the document’s clinical utility. In […]

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Streamline Your Approach to EMA Policy 0070

Policy 0070― published by the European Medical Agency (EMA) in October 2014― has made the world of regulatory writing a more complicated place. The policy requires specified submission documents to be made public for all marketing authorization applications (MAA’s) submitted as of January 1, 2015 and for all indication extensions and line extensions submitted as […]

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Best Practices for Complying with EMA Policy 70

EMA Policy 70 requires sponsors to publish anonymized versions of clinical study reports (CSRs) and submission documents submitted in support of a marketing authorization application (MAA) after January 1, 2015. Sponsors must prevent re-identification of people named or referred to in those documents. In March 2016, the detailed guidance document was published. This blog post […]

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Meet Pharma Transparency Mandates & Engage Study Participants

Most clinical study participants want to know the results of trials they participated in. However, few are actually informed. Lack of communication and transparency jeopardizes the success of the clinical research enterprise. In this blog post, I’ll discuss a new model for communicating trial results in lay language with minimum added burden on sponsors and […]

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Improve Your Approach to Sharing Clinical Trial Data

Transparency and disclosure of clinical trial data has been a hot topic, growing in prominence and strategic discussions over the past few years. Disclosing clinical trial information and creating transparency around clinical trial results are key steps toward increasing trust between the public and the industry. Increased transparency regarding data about ongoing research could spur […]

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What You Need to Know about the Precision Medicine Initiative

Last month, I was fortunate to be able to represent Certara at the BIO International Conference in Philadelphia, PA. One of the most exciting sessions that I attended was the Personalized Medicine Plenary with Dr. Francis Collins, the director of the NIH. He discussed how the Precision Medicine Initiative (PMI) will revolutionize the approach to […]

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How to Explain the Value of Modeling and Simulation to Your Grandma

As most scientists can attest, it’s not always easy to communicate the importance of your work to non-scientists. I personally experienced this when my fiercely intelligent grandmother, a former elementary school teacher, asked to read a copy of my dissertation. When I asked her what she thought of it, I realized that her understanding of […]

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Do the Right Thing: Ethical Mandates for Clinical Trial Transparency

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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Clinical Data Transparency Mandates Are Reshaping Regulatory Writing

New European and U.S. clinical trial data transparency initiatives—such as EMA Policy 70, which goes into effect this month—are creating additional disclosure compliance requirements for pharma and biotech companies. In this blog post, I’ll discuss the implications of these data transparency initiatives and present how Synchrogenix, powered by ClinGenuity and a Certara company, is addressing this emerging […]

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Strategic Regulatory Writing for Drug Development Success

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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