Clinical Development Consulting

Integrated Clinical Development Consulting

Our Solutions Clinical Development Product Development and Consulting Integrated Clinical Development Consulting

Move confidently with an interdisciplinary team of experts on your side

Do you want to move forward with less risk and more efficiency? Want to overcome the challenges and complexity of drug development to simplify the path from discovery through post-approval? We’re ready to guide you.

Our strategic clinical development consulting solutions bring together clinical development and regulatory strategy with pre-clinical and IND-enabling consulting and Phase I-IV trial design. In addition, we bring the breadth of development expertise of Thermo Fisher Scientific to ensure your product’s success.

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Intelligent drug development webinar

Efficiently navigate early clinical development.

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Areas of strategic consulting services

  • Clinical science
  • Regulatory
  • Toxicology

We can help you assess the best path forward to create a tailored regulatory, clinical development and total evidence-generation strategy:

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We are your partner, asking focused questions to understand how your product fits into the clinical, regulatory, medical affairs and market access landscape. This helps you make informed decisions to achieve your commercial goals.
We are seasoned product development consultants and experts. We work with you to identify and define targeted solutions across our portfolio for the right solutions at the right time. Through hands-on attention, we help you improve efficiency and speed to market, enabling a seamless handoff between phases and reducing your management of multiple suppliers.
We apply our knowledge to assemble the right team of experts, which may include clinical scientists, regulatory professionals, pharmacokineticists, pharmacologists, toxicologists and biostatisticians to create a roadmap for product success.
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We are a thought partner and extension of your team to expand and amplify your knowledge across the entire journey.
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Benefit from our breadth of strategic expertise

As a global provider of contract research organization (CRO) solutions with the ability to leverage Thermo Fisher’s breadth of capabilities, we offer what standalone consulting firms cannot. You will benefit from strategies grounded in our deep therapeutic expertise combined with our knowledge of the nuances of the disorder under investigation. Our experts will guide you through early development to post-marketing development strategies for the life cycle of the product to ensure efficiency and maximize patient safety.

Work with the only consultants to offer a true end-to-end solution

Seamlessly integrating clinical development consulting with a sound evidence strategy creates efficiency and builds greater confidence in health technology assessment (HTA) and reimbursement authorities’ acceptance, through market access, pricing and reimbursement.

Let us partner with you to navigate the product development life cycle

Our fully integrated multidisciplinary team provides insight and scientific expertise across the development life cycle, and a deep understanding of the key stakeholders — from investors and partners, regulators and payers to providers and patients. We can help you:

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Plan development strategy

Effectively plan a development strategy to navigate regulatory and competitive environments, as well as available and emerging treatments.

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Deliver development strategy

Deliver a comprehensive development strategy that lets you manage and deploy the right actions at the right time to hit your milestones.

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Navigate regulatory pathways

Assess and obtain the right regulatory pathway and/or special designation for your product to ensure the quickest and most effective route to approval. Develop convincing positions for regulatory acceptance of development plans and lead negotiations with regulatory agencies.

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Manage complex development needs

Manage complex development needs, including for advanced therapies such as cell and gene therapies, rare diseases, and crowded competitive markets.

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Provide manufacturing support

Provide manufacturing and “man-in-plant” support for both API and drug products to ensure you have the resources and solutions you need to keep programs on schedule. This includes contractor selection and management, formulation and process design, interpretation of scientific results, troubleshooting and failure investigations.

Ready to move forward?

We are ready to be your clinical development consulting partner.
Schedule a meeting to see how we can help.