Clinical Development

Clinical Development

The Smart Path from Phase I to Market Authorization

Clinical development turns drug candidates into therapies by aligning science, indication, and regulatory demands. At KLIFO, we support biotech and pharma leaders in defining strategies, fostering cross-functional collaboration, and integrating all key elements. Our experienced consultants combine strategic insight with hands-on execution, ensuring high-quality delivery from early development through to market authorization.

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Klifo, Glostrup. 07/10-2025

What is Clinical Development?

To put it simply, clinical development is the process that ensures that a drug product is thoroughly investigated, and that the safety, tolerability and efficacy is well documented for the evaluation of the overall benefit risk profile
In practice, it starts with the Target Product Profile (TPP), which is a blueprint outlining the desired product characteristics comprising the intended use, target population, and key chemical and physical features. The TPP ensures that research and development efforts are focused and aligned with clinical needs and regulatory requirements. Based upon the TPP, the clinical development strategy and clinical development plan are devised, which are then operationalized in plans and Clinical Trial Supply protocols for the required phase 1-3 studies.

Why Clinical Development Matters

Clinical development matters as it ensures that new treatments are safe, effective and that clinical benefit claims and assessment of benefit risk rest upon impeccable evidence. 
The importance of an early start of clinical development is often overlooked. While pharmaceutical development and non-clinical data will be the solid foundation for clinical development, the clinical strategy and TPP will also guide pharmaceutical development and non-clinical development. 
Clinical development is a diligent iterative process that involves interaction with CMC, non-clinical, regulatory experts and a series of interactions with regulatory bodies (national, EMA and the FDA) from initial scientific advice, Clinical Trial Supply applications, and the opening of an investigational new drug application (IND) for example.   
At KLIFO, we help you navigate this complexity with confidence. We take ownership of your clinical development challenges, working seamlessly alongside your team to resolve complexity and ensure regulatory maturity at every step. By partnering with us, you can be confident that we prioritize that: 

– Data (non-clinical and clinical) supports the planned next steps 
– There are no unnecessary delays in the overall development process (more non-clinical and CMC data and studies required)  
– Data supports regulatory approval and claims
– There will be no increased costs due to delays, rework and additional activities
– Investor confidence is untouched due to strict milestone adherence

Choosing KLIFO Means Choosing Confidence

30+ years’ experience across biotech, pharma, and CRO-led studies

Direct vendor coordination and transparent communication

No bureaucracy, no surprises — just results

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Our Clinical Development Services

KLIFO provides an integrated approach to clinical development, tailored to the specific needs of each client. We align CMC, non-clinical and clinical development activities with the regulatory requirements as well as your overall development strategy and business objectives.
Our services include:

  • Devising clinical development strategies and plans
  • Drafting Target Product Profiles
  • Conducting gap analyses from non-clinical to clinical in a regulatory perspective
  • Developing Clinical Trial Supply synopses
  • Conducting sample size estimations
  • Developing Clinical Trial Supply protocols
  • Assist in the interaction with regulatory bodies
  • Project management and clinical operational leadership
  • Vendor identification, contracting and oversight
  • Operational support (monitoring, eTMF management & GCP Compliance management)
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Typical Deliverables

At KLIFO, you gain more than advice – you work with dedicated experts who design tailored development strategies and protocols that meet EMA, FDA, and ICH standards. We ensure careful trial planning, cost control, and full project management, while embedded consultants proactively identify risks and opportunities to keep your clinical development on track.

Strategy and documentation

Experts delivering thorough review and de-novo development

Clinical development strategies and plans

Synopses and trial protocols in line with EMA, FDA, and ICH requirements

Execution and management

Trial planning focused on risk and cost minimization

End-to-end project management securing timelines

Embedded consultants spotting risks and opportunities

Guidance through every phase

Clinical Development activities don’t exist in isolation — they affect every stage, from preclinical planning to commercial supply.


Use the map to explore how our Clinical Development activities connects with each development phase, and how KLIFO supports you all the way to approval and beyond.

Navigating the regulatory landscape

Clinical development is inseparable from regulatory compliance. Global standards such as ICH guidelines, GCP requirements, and regional agency expectations (FDA, EMA) define how drug products must be developed and documented.

The regulatory requirements for clinical development can roughly be divided into:
– requirements related to the conduct of Clinical Trial Supply
– regulatory requirements for the overall clinical development strategy for a product.

Whereas the first are regulated under the GCP legislation in terms of compliance with e.g., administrative submission and approval procedures, safety reporting etc., the regulatory strategic input to the clinical development – is not, which leaves room for interpretation of e.g., regulatory clinical disease specific guidelines and recommendations from EMA and FDA.

KLIFO has robust in-house regulatory affairs expertise capable of providing regulatory strategic input the clinical development as well as undertaking regulatory support to the conduct of Clinical Trial Supply.

As regulations evolve, our consultants maintain vigilance, guiding clients through updates and ensuring readiness.

Flexibility

We adapt to your organization’s structure and ways of working

Responsiveness

We move fast—meeting urgent needs and seizing opportunities

Continuity

Whenever possible, the same team follows your project from start to finish

Depth

Our consultants draw not just on their own expertise but on the collective knowledge of KLIFO’s entire team

Integrity

We provide tailored solutions, not “off-the-shelf” approaches—and we act as your partner, not just your vendor

The KLIFO promise

Good medicines deserve to reach the market — but success requires more than science. It takes experience, regulatory maturity and flawless execution.

When you work with KLIFO, you get senior professionals who take ownership. We embed into your team, apply vertical insight, and ensure your drug product is developed, documented and delivered right.

Ready to address your clinical development needs?

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