Clinical Development Strategy

Clinical Development Strategy

Designing an Evidence Platform for Impact

Clinical development programs create differentiated and highly valued therapeutics – for patients, regulators, payers and healthcare professionals. We work to strategically define and refine your clinical development programs and ensure success in the market.

By combining our scientific expertise, market insights and forward-thinking methodologies, we delve deeper into the dynamic present to anticipate future trends and develop truly innovative strategies that make you stand out.

How We Do It

We apply a deep scientific and clinical understanding of the relevant therapy area or indication. And we do so as a true partner, collaborating closely with you to address your unique needs. Our involvement unifies stakeholder perspectives, driving focus and alignment across your organization.

This partnership, combined with powerful insights into current and future trends, as well as the regulatory and market landscape, provides a platform for us to build strategies for the future.

Why Work with Us?

We understand the trade-offs and critical questions necessary to design your development strategy. We continuously monitor the scientific landscape’s available data and regulatory frameworks to advance the design and definition of each phase in your clinical development plan.

We challenge you to push the boundaries strategically; to innovate and address unmet needs. Our outputs go beyond data, engaging stakeholders around the true value of your asset and inspiring actions that significantly impact patient lives.

Offers

Ways We Can Help

All our projects and programs are tailored to your unique context and challenges; however, these are some of the most common types of support we provide.

01 Clinical Trial Design Analysis and Benchmarking

Your clinical trial program constitutes the foundation needed to significantly improve patients’ lives. But to succeed, you must also address the needs of regulators, payers and healthcare professionals.

To unlock innovation, we apply hindsight, exploring analogous therapy areas. We delve into the present clinical development landscape. And we look to the future. We build prescient perspectives that identify the critical elements for success.

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02 Integrated Evidence Planning

To support the adoption of novel treatments, your data must be relevant and valuable to multiple stakeholders. Your clinical development plan is just the start: Ongoing evidence generation throughout the life of the asset is now essential to improve patient access to your medications.

We collaborate with you to bring together the perspectives of multiple stakeholders and functions within your organization. From these, we build a unified, holistic view of the evidence needed and the relative priority of its generation.

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03 Indication Sequencing

Achieving regulatory approval and reimbursement in a single indication takes time and resources. You must balance the time of entry with healthcare professionals’ experience while maintaining consistency in pricing. And you must do it all in the context of a competitive landscape.

Success requires expertise, experience, foresight and a collaborative mindset. Elements we’ll bring together to develop your sequencing strategy.

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04 Combinations Strategy

Defining the optimal combinations strategy requires rigorous evaluation of options within the context of an ever-evolving market and shifting competition. This includes evaluating how treatment approaches and selection can differ across countries and regulatory frameworks.

We bring together perspectives on future treatment dynamics to help you define a strategy that goes beyond the efficacy achieved with existing treatment options.

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05 Companion Diagnostics, Biomarkers and Device Analysis

Many novel treatments require a companion diagnostic or identification of a specific biomarker. The choice of an administration device also has a significant impact on adoption and the barriers to use.

We go deeper into customers’ current behaviors and the infrastructures that surround the testing and healthcare provisions for novel treatments. This shapes forward-looking scenarios in the context of the future competitive environment.

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