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Month: April 2016

Medical Writing Solutions From Synchrogenix

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High quality medical 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.

Transparency & Disclosure in Clinical Trials

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The issue of transparency and disclosure of clinical trial data has been growing in importance over the past few years. Disclosing clinical trial information and creating transparency around the data are key steps toward increasing trust between the public and the industry. Increased transparency regarding data about ongoing research could spur new products or therapeutic approaches and potentially avoid unnecessary trials.

Phoenix Workflow Template Services

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Escalating drug development costs combined with the ever-increasing complexity in bringing novel drugs to market have challenged the biopharmaceutical industry to develop and adopt methods that boost efficiency and productivity. Tools to validate safety and efficacy analyses faster, or help achieve regulatory compliance, can result in significant time and cost savings.

Simcyp Simulator

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The Simcyp Population-based Simulator streamlines drug development through the modeling and simulation of pharmacokinetics and pharmacodynamics in virtual populations. The Simcyp Simulator is the pharmaceutical industry’s most sophisticated platform for the prediction of drug-drug interactions and pharmacokinetic outcomes in clinical populations.

Cardiac Safety Simulator

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The Cardiac Safety Simulator™ (CSS) is a systems biology-driven, modeling and simulation-based platform for the assessment of the pro-arrhythmic potency of drugs, new chemical entities, and other xenobiotics within the targeted clinical population.

Academic Licenses

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Simcyp grants academic licenses for the Simcyp Simulator to centers of excellence in research related to drug development. Academic license agreements differ from Consortium member contracts to reflect the not-for-profit nature of the research. This makes them more accessible to scientists on non-commercial budgets.

Optimizing Drug Development Decisions

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Certara is a global biosimulation and regulatory writing company that uses modeling and simulation technology to inform and optimize the most crucial drug development decisions. The company has amassed the most scientifically advanced modeling and simulation approaches and aligned them with proven regulatory strategies to increase R&D productivity and the probability of commercial success for our clients.

Partnering for Pharmacometric Impact

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• Quantifying clinical trial efficacy, tolerability, and safety information to enable informed drug development decisions
• Incorporating quantitative pharmacology models for the effects of treatment, time, and patient characteristics on therapeutic outcome
• Competitive positioning, quantitative definition of Best-in-Class, assessment of drug class characteristics, and optimizing clinical trial designs

Minimize the Exposure of Children to Experimental Therapies

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Certara® is a leading drug development and drug safety consultancy trusted by thousands of biopharmaceutical companies worldwide. Offering a broad range of scientific consulting services and software solutions, from early drug discovery, to clinical development through product commercialization, Certara is the most comprehensive single-source solutions provider in the market.