Phase iV clinical trial

Phase iV clinical trial

Post-marketing evidence and long-term safety

Phase IV trials, also known as post-marketing studies, take place once a medicine has received market approval. At this stage, the focus shifts from demonstrating efficacy in controlled settings to understanding how the treatment performs in the real world — across diverse patient populations, longer treatment durations and in combination with other medicines.

These studies provide essential insights into long-term safety, comparative effectiveness and quality of life, support label extensions, health-economic evaluations and payer negotiations. In short, they ensure that the promise of a new treatment translates into real-world value for patients, prescribers and healthcare systems. 

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Klifo, Glostrup. 07/10-2025

The challenges of phase IV

Running post-marketing studies presents a unique set of challenges:

  • Recruitment difficulties, as the drug is already available outside the trial
  • Maintaining patient engagement and compliance over long periods
  • Managing very large and complex datasets
  • Ensuring study designs limit bias in real-world settings
  • Coordinating across multiple countries, sites and health registries

If not managed well, these issues can lead to incomplete data, poor reliability of results, reputational risks and missed opportunities for label extension or market differentiation.

That is why many companies turn to experienced partners to design robust post-marketing programmes, safeguard data integrity and align evidence with regulatory and payer expectations.

How KLIFO makes the difference

KLIFO brings the strategic and operational expertise needed to navigate phase IV. Our teams combine regulatory maturity, pharmacovigilance expertise and senior project management to deliver oversight that ensures high-quality evidence, even in complex, real-world settings.

These issues are not minor setbacks—they can derail With KLIFO, you gain a partner who not only runs the study but ensures that your post-marketing programme delivers evidence regulators, payers and prescribers can trust.

This translates into tangible results through:

Strategic trial design

ensuring protocols address regulatory, payer and post-marketing evidence requirements

Integrated pharmacovigilance

continuous safety monitoring and signal detection aligned with global requirements

Operational oversight

managing vendors, recruitment and patient follow-up across multiple countries and sites

Data quality focus

designing processes to handle large, decentralised datasets without compromising reliability

Flexible trial supply solutions

supporting long-term availability of investigational products in real-world trials

Klifo, Glostrup. 07/10-2025

Why choose KLIFO for your phase IV trial?

Phase IV requires a partner who understands the complexity of real-world data and long-term oversight. Companies choose KLIFO because we:

  • Provide direct senior expertise in pharmacovigilance, regulatory affairs and clinical operations
  • Deliver lean oversight that ensures data quality, compliance and predictability in outcomes
  • Act as an embedded partner, strengthening client teams with specialised insourced functions
  • Bring proven experience in designing and executing post-marketing studies that support label extensions and payer negotiations

How KLIFO makes the difference

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

Strategic advice and protocol synopsis development

Clinical Trial Supply Protocol (CTP) and informed consent forms

Project management plan, communication plan and timelines

Study oversight and responsibility split

Quality control plan, risk management plan and ongoing risk assessment

Safety management plan and pharmacovigilance activities

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

Statistical analysis plan and data management plan

Trial master file managed service and oversight

IMP and supply management for post-marketing trials

Clinical Trial Supply applications and regulatory submission

Study team/site staff training and investigator meetings

GxP audits and compliance oversight

Monitoring plan and targeted interim monitoring

Clinical Trial Supply report and post-marketing study reporting

Departments involved

Delivering a successful phase IV trial requires cross-functional expertise. At KLIFO, the following departments typically contribute:

  • Clinical Development
  • Clinical Trial Supply
  • Regulatory affairs
  • Quality assurance
  • Drug Development Consulting
  • CMC development
  • Pharmacovigilance

A partner for post-marketing success

A typical collaboration begins when a client seeks to generate evidence beyond approval — for long-term safety, real-world effectiveness or label extension. KLIFO’s experts refine the protocol, perform submissions, manage vendors and prepare operational plans. Once the study is live, we oversee recruitment, pharmacovigilance and data quality while ensuring compliance with GCP and regulatory expectations.

Phase IV is where a treatment proves its value beyond approval. With KLIFO, you gain the assurance that your post-marketing programme is guided by senior insight, executed with precision and always aligned with the belief that good medicines must continue to deliver value to the patients who need them.