Phase i clinical trial

Phase i clinical trial

Phase l Clinical Trial Supply: Navigating first-in-human studies with confidence

Entering phase l is a defining moment for any biotech company. It’s where your molecule is tested in humans for the first time — and where safety, tolerability and dose finding must be established to build the foundation for all later trials.

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Klifo, Glostrup. 07/10-2025

The critical first step

Entering phase l is a defining moment in drug development. It is where a promising molecule first meets the complexity of human biology. At this stage, the focus is safety, tolerability and dose finding — testing how the drug is absorbed, distributed, metabolised and excreted, and how it begins to act in the body. 

Phase l also provides the first insights into pharmacodynamics and an initial signal of the drug’s effect, forming the basis for later phase trials. Getting this right is essential if good medicines are to reach the patients who need them.

Whether first-in-human or a new indication, phase l demands careful planning, flawless execution and full compliance. Only then can you move forward with confidence into phase ll.

The challenges of phase l

Early Clinical Trial Supply are often underestimated. Many biotech and mid-size pharma teams step into phase l with strong science, but without the operational depth to navigate its complexity.

These issues are not minor setbacks—they can derail timelines, compromise data integrity and trigger regulatory pushback. And because phase l is the foundation for everything that follows, missteps here can jeopardise the entire development journey. In the worst cases, poorly designed phase l trials can expose participants to unnecessary risks or drain already limited funding—delays that few biotech companies can afford.
That is why many companies choose to bring in senior partners at this stage: to anticipate risks, build robust trial designs and keep execution on track.

The result is a familiar set of pitfalls:

Insufficient preclinical or safety data to support the Clinical Trial Supply Application (CTA)

Poorly justified starting dose and escalation scheme, often based on limited animal data or modelling

Overambitious or underpowered study objectives

Insufficient experience running phase l trials

IMP availability and formulation challenges

Site selection issues, including participant pool, site capabilities and equipment

Delays in bioanalytical method development (sensitivity and specificity)

Too few in-house staff to manage trial execution effectively

How KLIFO makes the difference

KLIFO’s specialists have decades of hands-on experience running phase l trials across multiple therapeutic areas. Unlike one-size-fits-all CROs, we combine senior expertise with lean, pragmatic project structures.

With KLIFO, you gain a partner who finalises your protocol, manages vendors, oversees recruitment and compliance, and safeguards both participants and your development timeline.

In practice, this means:

Fast communication lines and quick issue resolution

you work directly with experts, not layers of project bureaucracy

Tailored trial design and oversight

protocol synopses, dose escalation planning and informed consent forms that match your exact needs

Integrated expertise across functions

clinical operations, trial supplies, regulatory affairs, quality assurance, pharmacovigilance, CMC and Drug Development Consulting all under one roof

End-to-end delivery

from feasibility and vendor selection to ongoing risk assessment, safety management, monitoring and final trial reporting

Klifo, Glostrup. 07/10-2025

Why choose KLIFO for your phase l trial?

Phase l requires more than just a service provider. Companies work with KLIFO because we combine senior expertise with pragmatic structures that make the difference.

  • Direct senior expertise – highly experienced specialists who know how to avoid common pitfalls
  • Lean and agile structures – faster decision-making, no unnecessary layers, and efficient use of resources
  • Embedded collaboration – we act as an extension of your team, ensuring oversight, budget control and operational continuity
  • Proven experience – from oncology to rare diseases, our track record shows we deliver phase l trials that withstand regulatory scrutiny
About KLIFO

Typical deliverables in phase l

KLIFO provides the full range of deliverables needed to initiate, run and close a phase l trial:

Strategic advice and protocol synopsis development

Clinical Trial Supply Protocol (CTP) and informed consent forms

Project management plan, communication plan and timelines

Quality control plan, risk management plan and ongoing risk assessment

Safety management plan and study team training

Study oversight and responsibility split

Vendor management: request for proposal, assessment, selection and oversight

Statistical analysis plan and data management plan

Trial master file hosting and oversight

Monitoring plan and targeted interim monitoring

IMP and supply management

Clinical Trial Supply applications and regulatory submissions

GxP audits and compliance oversight

Clinical Trial Supply report at trial close

Guidance through every phase

Drug development is a long journey, and each phase builds on the one before it.

Use the map to explore how phase I connects to preclinical work, later-stage trials, regulatory milestones, and market approval.

Departments involved

Delivering a successful phase l trial requires multidisciplinary expertise. At KLIFO, the following departments typically contribute:

A partner for early success

In a typical engagement, a client approaches KLIFO with a near-final synopsis. Together, we refine the protocol, select and qualify sites and vendors, and prepare operational plans. Once the trial is live, we monitor recruitment, data quality, pharmacovigilance and vendor performance—keeping budgets and timelines under control while ensuring full GCP compliance.

Phase l is not the place for trial-and-error. With KLIFO, you gain the assurance that your first step into human trials is guided by senior insight and executed with precision.

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