Clinical Development

Is your Clinical Development strategy set to deliver to your target product profile and patient population?

In an ideal world, Clinical Development strategy and planning (from translational through early and late-stage Clinical Development (phase III-IV) start early in the lifecycle of a biotech. But let’s face it. Things don’t always work out that way, especially for disruptive technologies in rare disease, digital therapeutics, and gene therapy.

Often, “the plane is already in motion” when biotech leaders realize that they need a Clinical Development plan—and quickly. At this stage, the funding runway is often short, and securing additional financing without a clear clinical story at this stage is difficult. Unforeseen market volatility and unexpected outcomes can significantly impact developing a clinical product, so every effort must be made to project these possible obstacles as a progression in the commercialization of the product.

What you need is an approach to Clinical Development that’s as novel as the therapeutic you are bringing to market. It takes a proactive approach to integrate the perspectives of regulators and payers (across regions) to ensure endorsement by these key stakeholders.

Whether you are pressed for time or need help with a complex and novel Clinical Development strategy, we will help you with a discrete approach to trials, endpoint planning, and biomarker planning.

Our seasoned drug development experts will work with you to figure out where you are, create a strategy moving forward, and help execute the Clinical Development plan efficiently with you or for you. Our team is here to establish a CDP that minimizes risk, accelerates timelines, and avoids pitfalls throughout the drug development continuum.

An agile Clinical Development support team

Your Clinical Development needs ebb and flow. Hiring full-time employees with specialized skillsets only required in short sprints until key milestones are met may not be an efficient use of resources. It’s also important to decide whether independent contractors have the cross-functional expertise to plan and execute a Clinical Development process.

Our model is built around an agile approach. We bring in the exact skillsets you need at the right time. Instead of trying to find someone that can adequately fulfill disparate skill sets, you can get access to experienced experts for your exact needs.

We support clients throughout these three Clinical Development stages:

Establish Clinical Development Strategy

  • Initial indication selection for efficient proof of concept and commercial considerations in study designs
  • Clinical Development Planning process facilitation
  • Clinical Development Plan development
  • Clinical Strategy vetting
  • Endpoint & biomarkers selection (to meet regulatory and payer needs)
  • Regulatory alignment with Clinical Development
  • Cohort expansion strategies/population expansion

Execute Clinical Development

  • Protocol design & clinical trial planning
  • Clinical trial design
  • Protocol design
  • Support proactive engagement with health authorities (e.g., FDA, EMA, MHRA, etc.)
  • Development of Key Opinion Leaders (KOLs) and Advisory Panels
  • Site selection strategy (location, recruitment, etc.)

Develop Trial Design

  • Protocol synopsis development (inclusion/exclusion criteria)
  • Trial design vetting
  • Endpoint & biomarkers selection (to meet regulatory and payer needs)

We develop a protocol synopsis and protocol strategy and partner with a clinical writing team to write the development plan.

As your funding fluctuates and your Clinical Development requirements progress and change, we’ll work with you to meet milestones and derisk your organization through proper planning, management documentation, and execution. Our team members embed in your team to ensure you meet Clinical Development milestones on time.

Don’t go it alone. We are here for you.

Let’s talk.

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