Recent Advances in Development and Application of Physiologically-based Pharmacokinetic (PBPK) Models: A Transition from Academic Curiosity to Regulatory Acceptance

There is a renewed surge of interest in applications of physiologically-based pharmacokinetic (PBPK) models by the pharmaceutical industry and regulatory agencies. Developing PBPK models within a systems pharmacology context allows separation of the parameters pertaining to the animal or human body (the system) from that of the drug and the study design which is essential to develop […]

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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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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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Rare Disease and Orphan Drug Development

There are 7,000 rare diseases impacting 350 million patients worldwide, yet only 300 of these diseases have approved treatments. This gap, impacting 95% of those suffering from rare diseases, represents a huge unmet medical need. Modeling and simulation approaches are not only ideal for the development of drugs for rare diseases, but are encouraged by regulators.

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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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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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Integrating Regulatory Writing and Biosimulation into the Drug Development Process

As the adoption of biosimulation for drug development expands, so too does the need to integrate it into the documentation submitted to regulatory agencies. Biosimulation—also known as model-based drug development—includes physiologically-based pharmacokinetic (PBPK) and pharmacokinetic-pharmacodynamic (PK/PD) modeling. This methodology is emerging as not just an internal decision-making aid to reduce expenses and time, but also […]

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Engaging the Public in the Clinical Research Process

The issue of transparency and disclosure of clinical trial data has been growing in importance over the past few years. Clinical trials are essential to developing new therapies for patients. But the individuals that participate in those trial put themselves at risk. In return, the medical community has an ethical obligation to disclose clinical trials […]

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6500 Narratives in 6 Weeks

This top-20 biopharmaceutical company specializes in the discovery, development, manufacturing, and marketing of medications, with a focus on Oncology, Cardiovascular and Metabolic Disease, Respiratory, Inflammation and Autoimmunity. Synchrogenix® (a Certara® company), has been working with this global, top-20 biopharmaceutical company for 10 years. In that time, Synchrogenix has been contracted to support many therapeutic areas, […]

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New Drug Application – Preparation and Summarization of Modules 1-5 in Less Than 5 Months

This emerging biopharmaceutical company’s goal is to bring innovative therapies to market that provide unique and meaningful advantages to patients with renal disease as well as to their healthcare providers. Currently, this company has one product approved in Japan and two submissions in review; a Marketing Authorization Application (MAA) has been submitted to the European […]

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Synchrogenix Helps Sponsor Achieve Document Quality to Support Regulatory Filings

This specialty pharmaceutical company is focused on the development and commercialization of an immunosuppressant for the prevention of organ rejection in kidney transplant patients. Currently a Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMA) and a New Drug Application (NDA) with Orphan Drug Status is under review with the US […]

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