First-Time-in-Human Studies

Our overriding priority is delivering the right formulations that will generate the right clinical data for our clients to proceed to Phase II dose ranging studies. The core focus of our FTIH programs are speed, experience, and miniaturization.

 Clients benefit from these focus points by:

  1.  Preserving cashflow

  2. Preserving drug substance

  3. Capturing time sensitive opportunities

Speed

Whether to beat a competitor to market or hit an investment milestone, we understand that delays are unacceptable. Our team employs strategies learned from over a decade of senior management experience at global CDMOs to accelerate your molecule’s path to clinic, including simplified dosage forms, statistical design of experiment (DOE), and integrated analytical development. Combined with our streamlined bureaucracy and boutique flexibility, we are confident that Covar can meet or exceed the timelines proposed by any major CDMO worldwide.

Experience

With a Management Team that has led development of hundreds of molecules in both big pharma and global CDMOs, we have the experience to provide elegant and innovative solutions to FTIH clients of all shapes and sizes without discrimination against smaller companies.

Miniaturization

All formulation development and clinical supply manufacture are integrated into a single miniaturization site designed to produce scalable development batches that minimize drug substance consumption (g and mg scale) and reduce costs.

Common FTIH Dosage Forms:

  • Tablets (single or bilayer)

  • API/blend in capsule

  • Liquid filled capsules

  • Powder in bottle for reconstitution

  • Oral solutions and suspensions

Clinical sites and GLP toxicology can be coordinated through one of our strategic partners in the U.S. and Canada, or we can work with our clients’ vendors of preference.

Beneath the umbrella of FTIH services, Covar also offers a number of specialized capabilities, including:

  •  Bioavailability Enhancement (low solubility, low permeability)

  • Modified & Targeted Delivery

  • Nanoparticle Technologies

  • Specialty Dosage Forms