PK/PD Modeling & Simulation

Overcoming Pitfalls and Challenges with Software Validation

Noreen Muscat

As a quality consultant and quality system subject matter expert in the Life Sciences Industry for over 25 years, I have worked for many pharmaceutical companies both large and small and as a consultant with many clients in the pharmaceutical, biotech, and medical device industries. These clients possess a range of experience in software validation—from […]

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Topics: PK/PD Modeling & Simulation

Certara’s Best of the Blog 2017

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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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 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

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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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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How to Navigate “EMA Policy 70: Publication of Clinical Data” and Ensure Compliance

Nirpal Virdee

The issue of transparency and disclosure of clinical trial data has been growing over the past few years. Clinical trials are essential in offering new therapies to patients. However, individuals participating in these trials put themselves at risk, and therefore, the medical community is obligated to derive as much benefit from that risk as possible. […]

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Topics: Clinical Transparency & Disclosure

Regulatory and Medical Writing

High quality medical and regulatory writing is an essential part of any successful drug development program. Pharmaceutical and biotech companies need a trusted, agile, and experienced partner not only to write these documents, but also to act as a strategic partner and address key issues.

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