Phase IIb to IV clinical trials
Late phase clinical development
Pivotal trials and post-approval studies in neuroscience, infectious diseases and vaccines, and cardiometabolic diseases.
Approval is a checkpoint we meet time and again.
Meet our experts
Late phase CRO services
Hold the timeline. Protect the data.
Complex global programs need control, not layers.
In late phase, small problems compound. A country that activates slowly, enrollment that plateaus after the first sites open, or an endpoint read two different ways can cost you months when the stakes are highest.
So the decisions that hold a pivotal program together get settled before first patient in: country and site selection, endpoint definitions and adjudication, and where risk-based monitoring should focus. As your late phase CRO, AKEURA puts senior operational leads on your study with direct global oversight, and our medical monitors, biostatisticians, and safety specialists stay close enough to act on what the data shows.
Most of it sits in our three therapeutic areas, on purpose. A neuroscience trial with rater-dependent endpoints, a multinational vaccine program, and an outcomes trial in metabolic disease each fail in different ways, and our people have run each long enough to plan for the differences.
You’re covered for every phase
Pick up where your early phase left off
Late-phase proof at global scale
Pivotal and post-approval trials across our three therapeutic areas.
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250+
late-phase trials, Phase IIb to IV
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500k+
participants in late-phase trials
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3,500+
sites activated for global trials
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60+
countries where we've run trials
Deep expertise where late phase gets challenging
Neuroscience
Some of the hardest indications in medicine, run by people who have spent their careers in them. We know the endpoints, the raters and the sites that actually deliver.
Infectious diseases and vaccines
Respiratory and tropical infections, antimicrobial resistance, and global vaccine studies, run by teams on the ground where infectious diseases circulate. We read the epidemiology before we write the protocol.
Cardiometabolic diseases
Event-driven outcomes trials and the tough-to-recruit metabolic indications: obesity, diabetes, MASH, and lipid disorders. We keep the participants we recruit.
Six things that can go wrong in late phase, and how we approach them
These are the calls we get most, and none of them scare us.
Experience means we see problems coming. Tenacity gets you through the ones that arrive anyway.
When a study goes off track, get it moving again
Enrollment stalled. Activation behind plan.
Data slipping.
CRO performance off track, or a study that simply stopped moving. We find the root cause fast, choose the least disruptive recovery path, and get your study moving again, working within the protocol and never around it.
Tough gets us going. In neuroscience alone, we’ve rescued 18 studies in five years.
If we ran your early-phase work, the protocol decisions, site knowledge, and data standards come with your program into Phase IIb and III. If you’re joining us at late phase, or mid-study, we start by understanding what has already been decided, then build from there.
Every study run by the people you chose
Senior study leads you can reach directly, from first site activated to final report.
Late-phase CRO services
What we deliver in late phase
Before your pivotal trials, and beyond them
Early phase clinical development
Confident first steps from first dose to proof of concept, with answers your next study can trust
Real-world evidence studies
Regulatory-grade post-approval safety and effectiveness studies, led by RWE specialists who stay within reach
Frequently asked questions
Answers to your questions about late phase clinical development
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