Transform drug development for good

Start with the end in mind. Build the body of scientific evidence global regulators require from the start of your development process with expert regulatory strategy, advice and support. Use the same tools the regulators do to explore, analyze and interpret data. Anticipate feedback and questions while ensuring your data is available for review in the required industry-standard formats. Simplify workflows, accelerate document creation, and ensure error-free regulatory requirements are met across the globe.

Start strong by mitigating risks and prioritizing the right compounds for development. Streamline your design-make-test-analyze cycle with our services for due diligence, competitive landscape analysis, target product profile (TPP) development, cheminformatics and biosimulation to make predictive, data-driven decisions that enhance efficiency and improve your chances of discovering breakthrough therapies.

Progress your in vitro and early in vivo studies with the aid of biosimulation and proven drug development strategies. Build evidence and gain insight into your therapeutic window assessment and nonclinical plans (including CMC, toxicology, DMPK, clinical pharmacology, biomarker and regulatory strategies, First-in-Human design, and IND support). Explore dosing regimens, trial designs and drug interactions virtually before the trial commences. These crucial insights improve your chances of success.

We empower you to find the optimal path from the deluge of nonclinical, pharmacokinetic, pharmacodynamic, and clinical data to design the best strategy for trials and justify dosing with modeling and simulation. Interpret confounding data, target responding populations, maximize safety and efficacy tradeoffs, and predict the right dose. As your close partner, we streamline the journey from data to decisions, with the goal of informing comprehensive regulatory submissions.

Optimize pivotal trial designs to make the most of every enrolled patient. Use biosimulation to understand your therapy’s impact on different types of patient populations with virtual trials. Understand your data better with population modeling required to support comprehensive regulatory submissions. Achieve data standardization and prepare robust statistical analysis to support confident and compliant regulatory submissions. Leverage data to solidify your trial design and dosing strategy. Explore clinical trial outcomes, real world uptake scenarios and compare your therapy to others with AI-powered insight. Validate data for accuracy, and streamline decision-making across all trial phases for optimal results.

Achieve your product’s full potential with effective pricing, reimbursement, and patient access strategies aligned to your target product profile. Leverage real-time, real-world insights to strengthen your market positioning, secure optimal coverage, and ensure broad accessibility across markets. Demonstrate your therapy’s value over the competition with confidence and achieve success in your reimbursement negotiations, patient care and superior outcomes.