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Early-Phase Clinical Development

Structure your clinical development.
Protect your capital.

Senior clinical operations expertise for biotech companies entering human trials. Hands-on support from strategy to execution, without the full-time cost.

Virginie Barthel
18+
Years Experience
Early Phase
Specialization
Innovative therapies
Drug development

What we do

We structure and execute early clinical development for biotech companies.

NeoAlchemy Clinical supports biotech companies entering or navigating early clinical development where decisions are high-risk, capital is limited, and where structure and leadership are essential, but must remain tailored and proportional.

From strategy to execution, we help biotech teams transform scientific potential into structured, credible clinical programs that generate tangible company value.

Our core focus is early clinical development: from preclinical transition to Phase I & Proof of Concept where key value inflection points are defined.

We also support growing biotech companies that are beyond the early phase but not yet structured like large pharma. Organizations that need to:

  • Improve oversight and governance
  • Regain operational efficiency
  • Strengthen clinical leadership
  • Align execution with strategic and financial objectives

Whether you are launching your first trial or restructuring for performance, our approach remains the same: turn your vision into measurable progress with support tailored to your stage, resources, and ambitions.

Who we work with

For biotech leaders who want to create value through structure and execution.

We work primarily with early-stage biotech companies transitioning from preclinical to clinical development, when strategic clarity and operational rigor are critical to success.

Our typical partners include:

  • Founders preparing their first IND / CTA
  • Leadership teams structuring Phase I or Proof of Concept
  • Biotech companies selecting or managing their first CRO
  • Organizations preparing for investor discussions or fundraising milestones (Series A or B)

We also support growing biotech companies that:

  • Have entered clinical stages but lack structured oversight
  • Have experienced delays or difficulties in delivering key milestones
  • Need to reorganize their clinical governance
  • Want to optimize performance without building heavy big-pharma infrastructure

Our clients are looking for clarity, efficiency, and real progress.

They understand that early clinical development is more than running a clinical trial.
It is about building long-term company value.

They need the right expertise to support value creation and turn ambition into execution.

They trusted us

Trusted by teams who deliver

★ ★ ★ ★ ★

She anticipates, reassures and finds solutions, even in the most demanding situations. You immediately feel confident working with her.

Nathalie DoizeSr VP Clinical OperationsLinkedIn Recommendation
★ ★ ★ ★ ★

Virginie is definitively the best to answer questions or doubts in clinical trial field. Her knowledge does not have an end. She's got the power to elevate a team.

Ambre ChampougnyCRA, Co-manager, ECLORLinkedIn Recommendation
★ ★ ★ ★ ★

Virginie was the true cornerstone of the clinical, logistical, and operational teams. Her ability to harmonize efforts was essential to the achievement of our objectives.

Cecile GirodClinical Study Manager, SOCRA certifiedLinkedIn Recommendation

FAQ

Frequently asked questions

No. NeoAlchemy is not a CRO.

We do not replace operational vendors. We work alongside them and with you.

NeoAlchemy integrates into your team to provide strategic oversight, structure, and leadership.

You keep the flexibility of working with a consultant, while benefiting from the level of involvement and ownership of an internal leader.

It is the best of both worlds: Flexibility, Senior expertise and Strategic alignment.

Hiring is a major strategic step. Many biotech companies are not yet sure which profile they truly need, or whether they can sustain a full-time leadership position.

Working with NeoAlchemy allows you to:

  • Clarify your needs
  • Structure your organization
  • Build progressively
  • Protect your budget
  • Prepare your next steps

Once the structure is mature, hiring becomes clearer and safer.

Yes. NeoAlchemy often works alongside existing CROs to:

  • Reinforce the partnership and ensure smooth execution
  • Challenge assumptions
  • Protect timelines and budget
  • Ensure alignment with your strategy

A CRO executes. You still need internal strategic ownership.

Early clinical development is our core focus.

However, we also support growing biotech companies that need to restructure, strengthen governance, or improve performance without adopting heavy big-pharma infrastructure.

As early as possible. Ideally, 1 to 2 years before your expected First Patient In (FPI).

Early preparation allows you to:

  • Structure your Clinical Development Plan properly
  • Anticipate regulatory and operational challenges
  • Define realistic timelines and budgets
  • Select the right partners

The earlier we structure your strategy, the smoother your execution will be.

We start with a free introductory call to understand your situation and clarify what you will need and when.

You can also follow our founder on LinkedIn, where she regularly shares practical insights and free resources on early-phase clinical development.

NeoAlchemy supports innovative drug development programs, including small molecules, biologics, and advanced therapies such as cell and gene therapies.

The focus is primarily on early clinical development, particularly for complex or high-risk programs where structure, strategic clarity, and strong execution are critical.

Regardless of the modality, the objective remains the same: structure development efficiently and turn clinical progress into company value.

Every collaboration is tailored to your stage, scope, and level of involvement.

Senior expertise has a cost, but the fractional and flexible model allows you to access high-level clinical leadership without the fixed cost of a full-time executive.

The objective is to create value, protect capital, and prevent costly mistakes.

Engagements are structured to fit your needs and your budget whether for a focused strategic discussion or a longer-term partnership.

We discuss scope and investment transparently during our initial conversation.

Ready to structure your clinical development?

Let's start with a conversation.

Early clinical decisions shape long-term value. Let's make them count.