Regulatory & Medical Writing

Agreeing to Submission Document Timelines and Sticking to Them: Fairy Tale or Reality?

Steve Sibley

Does the thought of developing a submission for the marketing approval of a new drug fill you with dread? How do you avoid losing all of your holidays and weekends when developing a submission? Or burning out your team? In my career, I’ve helped teams develop robust submissions with minimal disruption to people’s lives and […]

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Topics: Regulatory & Medical Writing

New FDA Commissioner Endorses Use of M&S to Advance Drug Development

Suzanne Minton

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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Topics: Clinical Transparency & Disclosure, Model-based Meta-analysis, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing

Best Practices for a Successful eCTD Submission

Rob Connelly

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, […]

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Topics: Regulatory Submissions Management

Things About eCTD You May Not Have Known

Rob Connelly

In helping clients with their regulatory operations and electronic publishing needs, I’m often asked about preparing regulatory submissions in the electronic common technical document (eCTD) format. While a lot of us have been working in the eCTD format for many years, new start-up companies focusing on rare diseases and new technologies to treat patients are […]

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Topics: Regulatory & Medical Writing, Regulatory Submissions Management

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

Avoiding Pitfalls in Plain Language Summaries of Clinical Trial Results

Behtash Bahador

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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Topics: Clinical Transparency & Disclosure, Regulatory & Medical Writing

How AI Tech Is Changing Regulatory Writing

Nirpal Virdee

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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Topics: Clinical Transparency & Disclosure, Regulatory & Medical Writing

Certara’s Best of Blogs 2016

A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) 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 and sharing clinical trial results.

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Certara’s Synchrogenix Division Named to the 2016 Inc. 5000 List of the Fastest-growing Private Companies in America

PRINCETON, NJ – Aug. 29, 2016 – Certara, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today announced that Synchrogenix, its medical and regulatory writing consultancy, has been named to the 2016 Inc. 5000 list of the fastest-growing private companies in America.

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Meet Pharma Transparency Mandates & Engage Study Participants

Behtash Bahador

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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Topics: Clinical Transparency & Disclosure, Regulatory & Medical Writing

Certara’s Synchrogenix Division and PleaseTech Partner to Streamline Document Redaction Services

PRINCETON, NJ – Aug. 4, 2016 – Certara®, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today announced that its regulatory and medical consultancy, Synchrogenix, is partnering with document co-authoring and collaborative review specialist PleaseTech Ltd. to deliver a seamless regulatory document creation process.

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