Proven expertise and experience you can count on

Certara’s global consulting team has unparalleled experience across all development phases and in practically every therapeutic areas.

We have collaborated with sponsors, both large and small, to provide insight into key decisions, including:

  • What programs should be advanced in a strategic drug portfolio?
  • How can trials be designed to achieve technical and regulatory success? 
  • What are the optimal dose and regimen?
  • How can we minimize regulatory risk and expedite pathways?  
  • How do we optimize value and expand market access?

With the largest and most diverse, expert team of its kind, Certara’s 650+strong team of scientists, regulatory, and market access specialists have worked in virtually all therapeutic, including novel therapies and combination products, across the full range of regulatory pathways.

How we help our clients

Cardiovascular

We 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 failure (CHF), hypertension, deep vein thrombosis (DVT), and hyperlipidemia.

Central Nervous System

Our experience covers a broad range of diseases and conditions within the CNS, such as depression, epilepsy, Alzheimer's, multiple sclerosis, and more. We have developed models for assessing the probability a drug in development will be competitive with the standard of care and strategy for drugs with novel mechanisms of action.

Endocrinology

Our expertise in endocrine diseases includes diabetes, hypogonadism, hypoparathyroidism,, and obesity. We have supported diabetes programs from pre-clinical to Phase 4 commercial strategy. We have extensive knowledge on therapies such as glucagon-like peptide-1 (GLP-1) analogs and sodium/glucose cotransporter 2 (SGLT-2).

Immunology

Our projects in immunological disorders include rheumatoid arthritis, psoriasis, Crohn's disease, multiple sclerosis, and many more. We have also leveraged comparator data to support Phase 2b dose selection for the treatment of autoimmune disorders.

Infectious Disease

Drug development for infectious diseases faces challenges including compliance, viral dynamics, and drug resistance. Our experience includes viral dynamics/kinetics modeling and encompasses all development phases. We have covered most mechanisms of action including protease inhibitors, NNRTIs, NRTIs, and novel mechanisms.

Oncology

We have applied a range of modeling techniques to address critical decisions in oncology programs, 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 PBPK modeling and simulation.

Orphan/Rare Disease

Modeling and simulation approaches are not only ideal for orphan drugs but also encouraged by regulators. Certara has supported the approval of scores of orphan drugs using our pharmacometric solutions, including physiologically-based pharmacokinetics (PBPK) and population PK, and our deep regulatory and market access expertise.
Certara's better drug development process

We design and implement drug development strategies using quantitative science such as pharmacometrics, clinical pharmacology modeling, and model-based meta analysis . Our integrated approach weaves together many disciplines including regulatory science and evidence, value & access so that we can anticipate risks and inform critical decisions to achieve major milestones.

  • Get to proof of concept faster
  • Optimize trial design
  • Reduce trial size or avoid certain trials altogether
  • Expedite regulatory submissions
  • Expand patient access to medicines

We have scores of case studies and drug approvals to back our experience and success.

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Our partnership model

Drug development, the Certara way, is a team sport.  The high quality and outcomes of our partnerships are the result of dedication, collaboration, and deep expertise.

By choosing to partner with Certara, you tap into the expertise and insights of leading drug development, regulatory, and market access experts who are committed to finding the right answers and increasing the probability of your success.

We navigate complexity through flawless execution and stewardship with our top scientists and experts in pursuit of your goals.

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