Clinical Operations

Is your Clinical Operations team ready for first patient in?

In the evolving landscape of complex clinical trials you don’t need to spread your team thin to win.

You’re on your way to operationalizing your Clinical Development plan (rapidly advancing your medical innovations through the Clinical Development and regulatory approval lifecycle). You must meet clinical milestones to secure funding and advance to regulatory approval and commercialization. But let’s face it, most early biotechs are resource-constrained. To meet clinical milestones on time, you must select a CRO, manage vendor relationships, go through site feasibility and selection, and begin site start-up, not to mention management of the trial.

The challenge is if you spread your team thin between execution, as well as managing vendors and partners, you’ll lose momentum and risk missing milestones. And as we know efficiency for study planning and start-up, and throughout the conduct of your clinical trial is crucial.

It’s crucial at this stage to think strategically and cross-functionally about your Clinical Operations function. Traditionally, biotechs have leaned heavily on the CRO they select for strategic input. One challenge with working with a CRO, is that they are an external party that doesn’t always understand or align with the unique needs of your organization.

Alternatively, some biotechs manage many vendors separately to cut costs where they can, but managing those relationships takes a lot of internal resources. Resources needed to further your scientific story.

Our team acts as an extension of yours to take vendor management off of your plate, not add to it. We help you validate and operationalize your Clinical Development plan wherever you are in your Clinical Operations journey. We are here as your strategic Clinical Operations partner and program management team as you optimize clinical trial design, adopt patient-centric approaches and navigate regulatory pathways. Whether you are working in a single region or globally, our team has the experience to execute your clinical plan with you.

An agile Clinical Operations support team

Your Clinical Operations requirements 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. And individual contractors aren’t always considering the entire cross-functional Clinical Operations function.

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 our clients to:

Work cross-functionally with Clinical Development

  • Ensure your Clinical Development Plan is manageable
  • Ensure your Clinical Development Plan is feasible

Establish a Clinical Operations function

  • Organizational design
  • Program management
  • Vendor management
  • CRO selection
  • Finding, vetting, and onboarding
  • Strategic guidance for GCP training
  • Create a data management plan
  • Define and develop processes
  • Templates, timelines, SOPs

Interim Clin Ops services

  • Functional ops team
  • CRAs, clinical trial managers, etc.
  • Work with vendors to get licenses for assessments
  • Work hand in hand with data management
  • Guide data management

We are not a CRO, but we can help select a CRO and provide CRO oversight and management.

As your funding fluctuates and your Clinical Operations 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 and funding milestones on time.

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

Let’s talk.

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