Product Development Strategy
Maximize portfolio value & minimize risk with integrated clinical & commercial insights in your development planning.
To make the right calls on which drug candidates to pursue, you need early phase insights for more confident
The smartest product development strategies are informed by a clear grasp of market realities. The earlier you start, the better.
Integrating clinical and commercial objectives to maximize value and drive market adoptionAsset strategy – Positioning your product and your portfolio for success requires a thorough assessment of the growing number of stakeholders to anticipate their expectations for your product’s valueEvidence development – Optimizing your clinical, health economics & outcomes research to gather the right evidence from the start, saving time and effort after approval Go-to-market strategy – Strengthening your launch with pricing and reimbursement expertise, brand strategies and sales mobilization to ensure market success
Early Clinical Development
Answering the demand for pipeline productivity starts in early stage clinical development.
To make the right calls on which drug candidates to pursue, you need early phase insights.
Early clinical development requires specialized expertise to make better decisions earlier –
Proven early phase experience ~ 1,000+ studies from first-in-human trials to studies involving patients and special populations in all major therapeutic areas Best-in-class predictive tools to confirm compound viability – PK/PD modeling and simulation, early QT analysis and biomarkers Agility to adapt with new findings – Expertise in integrated protocols and adaptive trial designs Comprehensive early clinical capabilities – Global network of Phase 1 clinics, bioanalytical labs, ECG labs Commitment to ethics and safety – Protecting patient safety and meeting regulatory guidelines
Phase I/IIa Clinical Trials
Early development decisions can better inform your later phase trials.
Our Phase I/IIa scientists, seasoned project managers and clinical pharmacology units can help you assess safety, identify risks and set a sure course for development.
Phase I trials require facilities equipped with the latest medical technology while still offering healthy volunteers a safe, comfortable environment. Strategically located in Europe and the US, our Phase I units offer a comprehensive solution for your specific therapeutic area, geography, size and complexity. We’ll help you:
- Develop novel methods to accelerate proof of concept
- Determine dose escalation and titration regimens
- Access our deep bench of scientific experts and full pharmacokinetic / pharmacodynamic (PK/PD) services
- Establish definitive QT and perform TQT analysis with the industry’s largest staff of cardiologists
- Adhere to globally consistent quality standards for patient safety and regulatory guidelines
Phase II/III Clinical Trials
Faced with longer timelines, increasing regulatory demands and rising costs, your clinical trials are under more pressure to succeed.
It takes a pioneer’s perspective to maximize value and reduce risk every step of the way. Here’s how we can help.
Smarter clinical trial management for Phase II and Phase III trials
Optimize trial design with 30 years of experience and data insightsProvide therapeutic expertise at every stage of development Adapt as your trial progresses using advanced analytics Leverage local understanding of cultures and regulatory issues Accelerate patient enrollment – up to 87% of trials meet timelines Streamline clinical monitoring for better trial performance
Interventional Phase IIIb/Phase IV Clinical Trials
Post-marketing trials require agility and efficiency: Global infrastructure and site relationships to scale up to deliver large trials quickly and efficientlyIntegrated expertise in health outcomes, biostatistics, epidemiology and post-marketing regulations Streamlined operations that reduce time and cost
In the last three years, we’ve conducted more than 225 Phase IIIb and Phase IV trials to: Support new indications or label extensions Obtain or expand market access Support product differentiation and positioning Demonstrate efficacy and comparative effectiveness Meet post-marketing commitments Evaluate and monitor safety
Today’s health economics require you to navigate new terrain. Clinical and commercial endpoints are converging. Market planning can’t wait until submission. You need an integrated blueprint to align your clinical and commercial goals.
Entering new markets? AZR can help you understand all your stakeholders to support payer formulary adoption, negotiation of reimbursement, and messaging. The earlier we start, the better. We offer comprehensive expertise across the product continuum:
- Strategy – To differentiate your product, you must know what payers, providers and patients want and what evidence will demonstrate the value they look for.
- Evidence – Beyond clinical trials, you need to provide real-world outcomes to win market adoption. Moving with agility is key to streamline post-approval studies.
- Relationships – It’s critical to reach the right payers and decision makers with the right value proposition at the global, national and local levels.