Phase 1 Clinical Trials2024-09-25T10:48:17-04:00

Phase 1 Clinical Trials

Early-phase CNS studies are unique; and very different from trials in other indications that don’t involve the brain.  Drug, device, and technology developers working in psychiatric and neurological indications must document CNS activity, safety, pharmacokinetics, and pharmacodynamics.  It takes a company with the right expertise to deliver early-phase data that launches an investigational new treatment into late-phase clinical development.

At Clinilabs, we use our phase 1 unit to accelerate the development of these programs so our customers can get new treatments to market faster.  From simple FIH/SAD/MAD studies to complex biomarker, kinetic/dynamic, proof-of-concept, and global multicenter projects, we have it all to ensure that your development program moves swiftly and seamlessly from early-phase to late-phase clinical trials.
Impeccable execution.  Quality.  Speed.  Enabled by unparalleled CNS project teams.

  • First in human

  • First in class

  • Single ascending dose (SAD)

  • Multiple ascending dose (MAD)

  • Bioequivalence (BE)

  • Drug – drug interaction studies

  • Drug – alcohol interactions studies

  • Food effect studies

  • Pharmacokinetic (PK) studies

  • Pharmacodynamic (PD) studies

  • Kinetic-dynamic relationships

Remember the Three Princes of Serendip who went out looking for treasure? They didn’t find what they were looking for, but they kept finding things just as valuable. That’s serendipity, and our business [drugs] is full of it.

– George W. Merck

The cures we want aren’t going to fall from the sky. We have to get ladders and climb up and get them.

– Michael J. Fox

There is so much more to be done; the patients are waiting.

– Dr. Paul Janssen

The best way to predict the future is to invent it.

– Alan Kay

Advances in drug development have led to greater improvement in the quality of human life than advances in all other fields combined.

– Gary Zammit

All truths are easy to understand once they are discovered; the point is to discover them.

– Galileo Galilei

Let me tell you the secret that has led me to my goal. My strength lies solely in my tenacity.

– Louis Pasteur

Drugs don’t work in patients who don’t take them.

– C. Everett Koop, MD

One sometimes finds what one is not looking for.

– Alexander Fleming

The greatest joy in life is to accomplish. It is the getting, not the having. It is the giving, not the keeping.

– Sir Frederick Grant Banting

It is easy to get a thousand prescriptions, but hard to get one single remedy.

– Chinese Proverb

I must say, I spend a lot of my time these days trying to persuade people that controlled trials are the only way to get information that’s reliable about drugs.

– Louis Lasagna

Good information is the best medicine.

– Michael E. DeBakey

The reward for work well done is the opportunity to do more.

– Jonas Salk

I trust I may be enabled in the treatment of patients always to act with a single eye to their good.

– Joseph Lister

I am not accustomed to saying anything with certainty after only one or two observations.

– Andreas Vesalius

Without drugs, physicians would struggle to find relevance, and patients would suffer without hope.

– Gary Zammit

I have no ideology. My ideology is health.

– Dr. Anthony Fauci

If you think compliance is expensive, try non-compliance.

– Former US Attorney General Paul McNulty

One never notices what has been done; one can only see what remains to be done.

– Marie Curie

The pace of discovery is going unbelievably fast.

– James D. Watson

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