Next Generation Clinical Development

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Unlocking Program Value and Differentiation for Competitive Advantage in Next-Gen Research

As diseases become "smaller" and evidence sufficiency goal posts continue to shift, getting an asset’s development agenda right, while maintaining focus on successful adoption, requires a nuanced (and up-to-date) understanding of stakeholder value drivers, points of differentiation, evidence requirements and uncertainty.

Driving Productivity Across Your Development Portfolio

We have invested in three core proprietary services and related infrastructure to drive break-through productivity across your development portfolio.

Our Next Generation Product Development Value Levers:

1. Integrated Development Solutions (iDS) for clinical/commercial convergence

These are designed to ensure that trial design and execution leverage critical adoption criteria, such as patient nuance, and payer and provider value drivers, to accelerate launch success. Solutions include strategic program planning, precision development, translational tools, modeling and simulation (M&S), and evidence management.

  • Translational tools provide early evidence of therapeutic success, through disease model validation, human pharmacology models, molecular characterization (including biomarkers), and bioinformatics and PK/PD modeling.
  • Precision development enables us to maximize success through the systematic and strategic application of new data, modeling and analytics platforms that leverage critical adoption criteria to drive precision in program/study design, execution and launch.
  • Evidence management is the method whereby we engineer an "evidence backbone" that curates and analyzes critical adoption criteria throughout the development lifecycle to improve commercialization; it means the continual alignment of stakeholder values with the strategic intent of the business, and coordination of supply and demand through a formal end-to-end process.

2. Clinical model transformation to reduce white space and increase agility

Our operational strategy "innovation and engineering layer" links asset strategy to program execution for accelerated development, approval and adoption. Services include strategic sourcing, operating model redesign, and a drive towards focus, agility and quality, and operational efficiencies.

3. Site and patient experience optimization to implement new ways of working

This includes new, co-created engagement and partnership models based on redefining stakeholder experiences to increase site, investigator and patient loyalty. We enhance interactions with site partners and patients, improve quality, adherence and consistency, and ensure brand integrity.

 

Our Next Generation Clinical Research Team

Our team consists of tenured medical practitioners, investigators, program managers, former regulators, commercial strategists and product developers.

 

Next Generation Biopharmaceutical Product Development

We are frequently engaged by customers to help biopharmaceutical R&D organizations discover/retain agility, improve focus and enable growth through creative operating models and transformation initiatives.

Agility and Transformation
We achieve post-merger integration through process harmonization, organization design and technology selection. We also have a partnership and outsourcing paradigm, clinical research analytics and evidence model, and end-to-end delivery model redesign.

Product Operations Improvement
This includes global process and technology harmonization, product regulatory strategy, quality systems/PAI readiness, IND/NDA submissions readiness, and global safety/pharmacovigilance.

Site Experience Optimization
We do this through consistent, simplified interfaces and communications, "Trust Principles of Engagement" across partners, and supporting processes, roles and responsibilities, optimized for mutual benefit.

Our new clinical models solve the operational divide between intent and execution. We have deep experience in clinical development change management in multiple engagements, extensive experience creating new organizational structures and strategies in large EBITDA improvement and post merger integration scenarios, a proven track record of achieving results in multiple stakeholder, politically-charged environments, and a proprietary "change adaptive" co-creation approach to change management that emphasizes stakeholder experience and co-created interactive engagement platforms to increase adoption of a new operating model.