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Clinical Development Solutions

Clinical Development SolutionsClinical Development SolutionsClinical Development Solutions

Expertise in clinical development, biostatistics, data analytics, regulatory strategy and submissions

Contact us

Clinical Development Solutions

Clinical Development SolutionsClinical Development SolutionsClinical Development Solutions

Expertise in clinical development, biostatistics, data analytics, regulatory strategy and submissions

Contact us

About Us

Why us?

How we can help?

A company with a team of professionals who each have more than 15 years of experience in the design, conduct, analysis and regulatory submissions of drug, devices and diagnostic agents. 

How we can help?

How we can help?

We can support designing, executing clinical trials for trial sponsors of any size from biotech startups to big pharmaceuticals. We can tailor to the requirements of the sponsors

Experience the difference

Experience the difference

End to end clinical trial services, Specializes working with small and medium sized companies, Full range of expertise and experience in oncology, neurology, metbolic diseases, rare and orphan diseases, led or involved in at least 10 NDAs, BLAs, INDs, PMAs

Our Services

Drug Discovery and Preclinical Research Services

  • Target identification and validation
  • Drug screening and candidate selection
  • Cell line study strategy
  • Preclinical strategy

Non-clinical and Pharmacokinetics

  • Animal study strategy and analysis
  • Pharmacokinetics and pharmacodynamics 
  • Project Olympus and PBPK studies
  • IND planning and submission

Clinical strategy, planning and operations

  • Phase 1 study planning and operations
  • Efficient dose escalation and dose ranging studies using Bayesian based designs
  • End-of-Phase 1 and End-of-Phase 2 planning and regulatory interactions
  • Clinical strategy for drug registration and regulatory planning
  • Efficient and accelerated Phases 2 and 3 study designs and development
  • provide services in protocol and statistical analysis plan development, clinical operations, data management, biostatistics and statistical programming areas
  • support regulatory interactions including Regulatory agency meeting strategies, briefing package development and responses to questions from regulatory agencies

Contact Us

Drop us a line!

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Celyxa, inc

Irvine, California, United States

Copyright © 2026 Celyxa, inc - All Rights Reserved.


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