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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. […]

Author(s): Kelley Kendle
Solution: Clinical Transparency & Disclosure, Regulatory & Medical Writing
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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 […]

Solution: Regulatory & Medical Writing
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Synchrogenix Transparency Service Case Study: Sponsor A

Sponsor A, a top-10 pharmaceutical company, committed to publishing Clinical Study Reports (CSRs) for clinical outcome trials for all medicines that reached the market, dating back to the formation of the company since its last merger. Sponsor A set an objective to become the most transparent pharmaceutical company in the industry and provide leadership that […]

Solution: Clinical Transparency & Disclosure
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Synchrogenix Transparency Service Case Study: Sponsor B

Sponsor B, a top-10 pharmaceutical company, supports policies and actions that seek to appropriately enhance scientific exchange. They are committed to providing access to anonymized patient data and full Clinical Study Reports (CSRs) from their clinical trials to qualified scientific researchers. They are supportive of the European Federation of Pharmaceutical Industries & Associations (EFPIA) and […]

Solution: Clinical Transparency & Disclosure
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Certara’s ClinGenuity Named a “Cool Vendor” in Gartner’s 2015 Life Sciences Report

PRINCETON, NJ – Apr. 30, 2015 – Certara®, the global biosimulation technology-enabled drug development consultancy, today announced that its ClinGenuity company has been named a “Cool Vendor” in Gartner, Inc.’s 2015 Life Sciences report1. ClinGenuity was acquired by Synchrogenix, Certara’s regulatory writing company, in January 2015. “We are delighted that Gartner has recognized us,” said […]

Solution: Clinical Transparency & Disclosure
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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 […]

Solution: Clinical Transparency & Disclosure, Regulatory & Medical Writing
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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 […]

Speaker(s): Tatyana Wanderer
Solution: Clinical Transparency & Disclosure, Regulatory & Medical Writing
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Avoiding Pitfalls in Plain Language Summaries of Clinical Trial Results

In this webinar, Tatyana Wanderer and Behtash Bahador provided insights and recommendations gained from working with leading sponsors on portfolio-wide implementation and pilot programs to create plain language summaries of clinical trial results.

Speaker(s): Tatyana Wanderer, Behtash Bahador
Solution: Clinical Transparency & Disclosure, Regulatory & Medical Writing
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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 […]

Author(s): Behtash Bahador
Solution: Clinical Transparency & Disclosure, Regulatory & Medical Writing
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