Pharmacology to Payer

Pharmacology to Payer

Focus on Patient Centricity In traditional drug development, limited engagement—or engagement too late in the development program—between sponsors, regulators, and payers can result in unacceptable delays of patient access to life-saving medicines. While alternative approaches such as Adaptive Licensing, which includes staggered approval, managed entry, and progressive authorization have expedited the process, it addresses only […]

Read More
Topics:

Drug Development and Clinical Pharmacology Strategy

Strategic Drug Development Involves Thinking Without Borders™ Certara has demonstrated that a modern, state-of-the-art integrated drug development approach, using quantitative methods to inform, guide, and supplant traditional development methods, will dramatically improve efficiency and reduce costs. Creating unquestionable value for our clients is our objective. To achieve these objectives, Certara employs a strategic and programmatic […]

Read More
Topics:

Clinical Outcomes Databases for Specific Therapeutic Areas

About 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 More
Topics:

Immunology

Strategic 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 More
Topics:

Quantitative Systems Pharmacology

QSP: Integrating Quantitative Drug Data with Knowledge of Its Mechanism of Action One of the biggest challenges—and, hence, the biggest opportunity for QSP—is drug attrition in Phase 2 clinical trials. Investigational medicines are usually tested for the first time in patients in Phase 2 clinical trials. This is the point when many drug programs fail. […]

Read More
Topics:

Oncology

Oncology: 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 More
Topics:

Infectious Disease

Infectious 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 More
Topics:

Endocrinology

Endocrinology: 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 More
Topics:

Central Nervous System

Central 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 More
Topics:

Cardiovascular

Cardiovascular: 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 More
Topics:

Therapeutic Areas

Therapeutic 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 More
Topics:

Clinical Trial Outcomes Databases

Clinical 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 More
Topics:

Orphan Drug Development

Orphan Drugs: Unique Challenges Require Unique Development Approaches Developing drugs for rare diseases poses a range of clinical, regulatory and commercial challenges. The small number of patient populations are difficult to identify and recruit for clinical trials. Many orphan diseases are genetic. Often these patients have complex phenotypes that react very differently to proposed treatment […]

Read More
Topics:

PK/PD Drug and Disease Modeling and Simulation

Quantifying Drug, Disease, and Trial Information to Aid Efficient Drug Development For almost 20 years, our pharmacometricians have combined insight and innovation to build quantitative models of the interactions between the human body, drug effects, and diseases. Our team develops models that are fit-for-purpose and meet strategic objectives, are aligned with regulatory authority requirements and […]

Read More
Topics:
Learn More LinkedIn Twitter Facebook Email Subscribe to the Blog