Phase 1 Clinical Trials

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

At Clinilabs Drug Development Corporation, we use our phase 1 unit to accelerate drug development programs so our customers can get new medicines 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

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

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

– Alan Kay

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

– Chinese Proverb

I have no ideology. My ideology is health.

– Dr. Anthony Fauci

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

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

– Gary Zammit

One sometimes finds what one is not looking for.

– Alexander Fleming

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

– C. Everett Koop, MD

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

– Jonas Salk

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

– Galileo Galilei

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

– Former US Attorney General Paul McNulty

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

– Louis Pasteur

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

– Dr. Paul Janssen

The pace of discovery is going unbelievably fast.

– James D. Watson

Good information is the best medicine.

– Michael E. DeBakey

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

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

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

– Marie Curie

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