Certara is the leading drug development consultancy with solutions spanning the discovery, preclinical and clinical stages of drug development.
Publicly available clinical trial data represent an underutilized source of information. If properly extracted and analyzed, the data provide valuable input for facilitating go/no go decisions, performing comparative effectiveness and portfolio evaluations in support of in/out licensing, and optimizing overall drug development decisions, including dose and dosing regimens. Clinical Outcomes Database Explorer, CODEx, is an […]
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Publicly available clinical trial data represents an underutilized source of information. If properly extracted and analyzed, they provide valuable information to support drug development decisions. When you think of the volumes of public information and databases that are available to determine, for example, commercial viability of a therapeutic in development, your first inclination is—“great!” But […]
Read MoreAbout our Clinical Trial Outcomes Databases Our Clinical Trial Outcomes Databases form a quantitative framework to leverage valuable external data, providing key development insights to maximize the probability of success for a new drug. Comparative effectiveness Endpoint and subpopulation relationships Biomarker efficacy and safety outcome Trial design optimization Competitive analysis and commercial viability Gathering, formatting, […]
Read MoreStrategic Modeling and Simulation Services for Autoimmune Disorders Certara Strategic Consulting scientists have extensive experience in immunological disorders. We have also leveraged comparator data to support Phase 2b dose selection for the treatment of autoimmune disorders. Disease Areas Rheumatoid arthritis Psoriasis Crohn’s disease Systemic sclerosis Multiple sclerosis Clinical Trial Outcomes Databases We have developed an […]
Read MoreOncology: Strategic Modeling and Simulation Services Certara has extensive experience supporting oncology drug development. In addition, we have applied a range of modeling techniques to address critical decisions from pre-clinical to late stage clinical for antibodies, proteins and small molecules, such as C-QT modeling, metadata analysis, preclinical to Phase 2 PK and TK analysis, and […]
Read MoreInfectious Disease: Strategic Modeling and Simulation Services Drug development for infectious diseases faces unique challenges including compliance, viral dynamics, and drug resistance. Certara has extensive experience in infectious disease projects, including many HIV and HCV viral dynamics/kinetics modeling projects over the past decade, in all clinical development phases. We have covered critical issues in trial […]
Read MoreEndocrinology: Strategic Modeling and Simulation Services Certara has broad expertise in endocrine diseases including diabetes, obesity, hypogonadism, and hypoparathyroidism. For example, our scientists have supported diabetes development programs for industry clients, from pre-clinical to Phase 4 commercial strategy. Our consultants have addressed critical issues in trial design, dose selection, extrapolation from animal to human, and development […]
Read MoreCentral Nervous System: Strategic Modeling and Simulation Services Certara has extensive experience supporting Central Nervous System (CNS) projects for industry clients, spanning all phases of clinical development. Our consultants have addressed key issues in trial design, choice of indication, and development strategy for drugs with novel mechanisms of action. We have developed models for assessing […]
Read MoreCardiovascular: Strategic Modeling and Simulation Services Certara has extensive experience in modeling and simulation to support cardiovascular drug development across all phases of clinical development. Our consultants have addressed key issues in trial design, dose selection, and development strategy for a broad range of cardiovascular diseases and conditions, including pulmonary arterial hypertension (PAH), congestive heart […]
Read MoreTherapeutic Areas of Expertise: Strategic Drug Development Services Certara’s global consulting team has unparalleled experience across all development phases and in all major therapeutic areas. We have collaborated with sponsors, both large and small to provide insight into key decisions, including dosing and toxicity; efficacy and biological impact; comparative effectiveness; clinical trial design; regulatory strategy; and […]
Read MoreClinical Trial Outcomes Databases Quantify Your Competitive Edge Along the development path of a compound, sponsors make critical decisions to ensure drug approval and market success. Success depends not only on the drug’s performance, but also on the competitive landscape, requiring reliable assessments—now and for the future—of your competition. Gain Faster Time to Insight What […]
Read MoreAn Innovative Strategy to Make Better Use of Available Data The difference between getting a new medication to patients, and it ending up in the scrap heap of failed programs lies in making the right choices. There is a surfeit of publicly available information on approved drugs as well as those currently in development. How […]
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