Nitrosamine Impurities Affecting Drug-Drug Interaction Studies – Learn More

Speed. Flexibility. Agility. Quality.


Complex clinical studies on a global scale

Phase 2-3 Clinical Development

We have what it takes in today’s rapidly changing clinical and regulatory environments to guide you through each critical checkpoint of drug development.  As “the right size” CRO Celerion is well-positioned to adapt to the ever increasing complexity of clinical trials. We identify challenges in the earliest stages of development and are well prepared to take your study to its full potential.  Whether they are difficult to recruit trials in rare or orphan indications, multi-arm or adaptive design trials with sophisticated IMP setup, complex logistic, or trials with heavy recruitment competition, we have the ability to deliver robust and reliable results.

 


Your Needs. Our Solution.

If you are looking for adaptive clinical trial designs, our experienced clinical operations, pharmacology, pharmacokinetics and biostatistics teams will work with you to tailor a solution to your unique needs. The clinical research professionals at Celerion have extensive experience and expertise in managing complex studies. We help you to transition through Proof of Concept and beyond with a particular focus on the following disease areas: vaccines oncology (over 25 indications within this complex therapeutic area), immunotherapy, infectious disease (viral or bacterial), hepatic or renal insufficiency, respiratory disease (asthma, COPD, cystic fibrosis), and other therapeutic experience including metabolism (NASH, NAFLD, obesity, T2DM).

 


We Get Results

Celerion’s Global Clinical Development team works within a robust quality management system to ensure superior results demanded of a highly regulated industry. Our experienced project managers use proven, streamlined processes assuring you of compliance and data integrity. With Celerion’s accumulated experience of nearly 1000 studies in over 30 countries, we help you gain valuable insights from protocol development through study conduct, analysis and reporting.

  • We minimize your risk through early problem identification, implementation of mitigation strategies, and through close monitoring of project plans and key project and decision drivers.
  • Your study is executed by highly-trained and organized teams that are closely coordinated through streamlined communication and have rapid access to senior management via a flat organizational structure
  • Monitoring plans are tailored to each specific study, whether using our CORE Monitoring approach, a compliance-oriented methodology taking into account each study site, deploying risk-based monitoring, or a custom solution

Full Service Global Clinical Development

Celerion, a full-service, early clinical CRO, is the leader in accelerating development for Phase I-IIb. Our unique combination of medical expertise, clinical operations experience and scientific excellence, enables you to make timely decisions with expert advice and high-quality data. Our leadership in clinical pharmacology through Proof-of-Concept is focused on helping you translate your science to medicine.

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