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

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

EMA Policy 0070 Compliance Tips from James Bond

Lora Killian

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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Topics: Clinical Transparency & Disclosure

Streamline Your Approach to EMA Policy 0070

Lora Killian

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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Topics: Clinical Transparency & Disclosure

Best Practices for Complying with EMA Policy 70

Lora Killian

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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Topics: Clinical Transparency & Disclosure

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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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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A New Model to Meet BioPharm Transparency Mandates and Engage Participants as Clinical Research Partners

Studies consistently show that 90% of clinical trial volunteers expect to be told the overall results of their trial. Unfortunately, most never hear anything back from the Sponsor or research center after the last study visit, leaving many volunteers wondering if their participation was valued or appreciated. Over the past five years, the nonprofit Center […]

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Artificial Intelligence Technology

Through the use of Artificial Intelligence technology, Synchrogenix has developed a solution in the area of regulatory and medical writing that truly meets the promise of automated authoring, and is also the most effective and efficient approach to mitigate risk for meeting data transparency requirements.

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Synchrogenix ClinGenuity Redaction Management Solution (CRMS)

Synchrogenix’s unique AI engine, has created an engine that is built on natural language processing and recognition. Because of the power behind our unique AI, the engine can be configured to identify PPD and CCI the same way an individual would be trained on these definitions. The process of identifying and redacting sensitive information becomes automated and significantly more accurate.

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