Phase ii

Phase ii

Moving from safety to efficacy

For biotech companies, phase II is where real proof begins. Your molecule must now demonstrate efficacy in larger patient groups and confirm the right dose and regimen. Getting this right is what enables you to move confidently into pivotal trials — and it requires careful planning, flawless execution and regulatory alignment.

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What happens in phase II trials

Phase II trials are where development shifts from demonstrating basic safety (tested in phase l) to understanding dosage and efficacy in larger patient groups. These trials are often randomised and controlled, involving relatively homogenous populations.

Within phase II, trials are sometimes divided into lla and llb. Phase lla explores early signals of efficacy, optimal dose and scheduling, as well as pharmacokinetics and pharmacodynamics. Phase IIb evaluates therapeutic effect in broader populations, confirming dosage, administration method and consistency of response and refining patient population definition. Together, they provide the foundation for phase III.

The overall objective of phase II is clear: to generate robust evidence of efficacy, safety, patient population and treatment regimen so the drug can progress into pivotal trials. Getting this right is essential if good medicines are to reach the patients who need them.

The challenges of phase II

Despite promising signals from phase l, many companies face setbacks in phase ll.

The consequences can be severe: failed or delayed trials, regulatory pushback, pipeline setbacks, unfavourable business cases, reputational damage or even programme termination.

That is why many companies turn to experienced partners at this stage — to build robust trial designs, manage operational risks and secure the evidence regulators and investors expect.

Typical challenges include:

Lack of efficacy when tested against placebo or larger populations

Safety issues emerging in patients with comorbidities or multiple medications

Poor study design that weakens results

Recruitment challenges due to narrow populations or poor site selection

Biomarker or diagnostic failures that do not correlate with treatment effect

Inconsistent drug response in subgroups of patients

Drug formulation and supply problems

Financial or strategic timing constraints

How KLIFO makes the difference

KLIFO brings more than operational capability — we bring the strategic depth needed to navigate Phase II, where promising compounds often fail. Our teams combine regulatory maturity with hands-on trial execution to ensure your programme produces the compelling evidence required to advance.

With KLIFO, you avoid the pitfalls of inconsistent efficacy, poor recruitment and fragmented oversight, ensuring your Phase ll trial delivers the clarity needed to justify Phase lll investment.

Strengthening study design

integrating biomarkers, endpoints and patient stratification to capture efficacy signals.

Optimizing dose and schedule

drawing on senior pharmacology and CMC expertise to refine treatment regimens.

Recruitment and site strategy

selecting and initiating sites with proven access to the right patient populations.

Integrated functions under one roof

clinical operations, Clinical Trial Supply, regulatory affairs, pharmacovigilance, quality assurance, CMC and Drug Development Consulting working seamlessly together.

Operational control

risk assessment, vendor oversight, supply chain management, recruitment follow-up and continuous GCP compliance.

Klifo, Glostrup. 07/10-2025

Why choose KLIFO for your phase II trial?

Phase ll is where many programmes fail to deliver compelling evidence. Companies choose KLIFO because we:

  • Provide direct senior expertise across strategy and execution
  • Work in lean and agile structures that accelerate decision-making
  • Offer embedded collaboration, acting as an extension of your team
  • Bring proven experience across indications, ensuring trials meet regulatory and scientific expectations
About KLIFO

Typical deliverables in phase ll

KLIFO provides the full range of deliverables required to initiate, manage and complete a phase II trial:

Strategic advice and protocol synopsis development

Clinical Trial Supply Protocol (CTP) and informed consent forms

Study oversight/sponsor oversight plan

Project management plan, communication plan and timelines

Quality control plan, risk management plan and ongoing risk assessment

Safety management plan

Study team and site staff training

Trial oversight and responsibility split

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

Statistical analysis plan and data management plan

Trial master file managed service and oversight

Monitoring plan and targeted interim monitoring

IMP and supply management

Clinical Trial Supply applications and investigational new drug applications

Trial reporting and Clinical Trial Supply report

GxP audits and compliance oversight

Guidance through every phase

Phase II is one step in your development journey.
See how KLIFO supports you across every phase

Departments involved

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

A partner for success beyond safety

A typical collaboration begins when a client has a promising drug candidate from phase l and is preparing to enter phase II. Together, we finalise the protocol, conduct feasibility and site selection, and qualify vendors. KLIFO then manages operational tasks, supports the Clinical Trial Supply application, initiates risk assessment and prepares supply logistics. Once the study is live, we oversee recruitment, data quality, pharmacovigilance and compliance with GCP—always with budget and timelines under control.

Phase II is where evidence must be convincing. With KLIFO, you gain the assurance that your trial is guided by senior insight, executed with precision and built on the belief that good medicines deserve to reach the patients who need them.

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