Clinical Transparency & Disclosure

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

Certara Launches CODEx to Inform Comparative Effectiveness and Drug Development Decisions

PRINCETON, NJ – June 6, 2017 – Certara today launched its Clinical Outcomes Database Explorer (CODEx). An intuitive, web-based platform, CODEx enables drug development teams to easily visualize, explore, analyze and communicate content from Certara’s Clinical Trial Outcomes Databases and assess a given compound’s probability of success against competitor drugs.

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Quantify Osteoarthritis Pain Clinical Outcomes Database

The current version of the database includes clinical safety and efficacy information on treatment options currently approved or in development for osteoarthritis pain. The current version of the database includes information on all systemic pharmacological interventions. This includes mono and combination therapy with NSAIDs, acetaminophen, opioids, COX-2 inhibitors, norepinephrine reuptake inhibitors, anti-NGF, anti-epileptic drugs (AEDs), antidepressants, and muscle relaxants.

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Quantify HBV Clinical Outcomes Database

The Quantify HBV Database is developed to document clinical safety and efficacy information on different nucleosides (eg, entecavir, lamivudine, tenofovir disoproxil fumarate, telbivudine, adefovir and combination) focusing on 3 different endpoints: HBV DNA time course, HBsAG time course, and HBeAG seroconversion that are available in the public domain.

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Quantify Chronic Lower Back Pain Clinical Outcomes Database

The current version of the database includes clinical safety and efficacy information on treatment options currently approved or in development for chronic lower back pain. The current version of the database includes information on all systemic pharmacological interventions. This includes mono and combination therapy with NSAIDs, acetaminophen, opioids, COX-2 inhibitors, norepinephrine reuptake inhibitors, anti-NGF, anti-epileptic drugs (AEDs), antidepressants, and muscle relaxants.

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Quantify Neuropathic Pain Clinical Outcomes Database

The current version of the database includes clinical safety and efficacy information on treatment options currently approved or in development for painful diabetic neuropathy (DPN), post herpetic neuralgia (PHN), or fibromyalgia. Information on older treatment options (such as tricyclic antidepressants) was included if they are used as active controls.

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Quantify Glaucoma Clinical Outcomes Database

The Quantify Glaucoma Clinical Outcomes Database is developed to document clinical safety and efficacy information from all randomized placebo and active controlled trials in patients with ocular hypertension or (open angle) glaucoma treated with latanoprost, bimatoprost, travoprost, tafluprost, dorzolamide, brinzolamide or timolol (timolol is included as control only). Trials in the database also include washout designs and add on designs.

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Quantify RA Clinical Outcomes Database

The current version of the database includes clinical safety and efficacy information on all biologics as well as newer synthetic DMARDs currently approved or in development for rheumatoid arthritis (RA). Information on older treatment options (MTX and other DMARDs) was included if they are used as active controls.

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