How Town & Country Compounding can be valuable in Clinical Trials Phase I & II

Town & Country Compounding has the resources you need to conduct the most advanced research & development or clinical trials.

Our accreditations place us in the top 1% of compounding pharmacies

Town & Country Compounding
can be valuable in

Phase I & II
of Clinical Trials

Randomization, Packaging, Labeling and Tracking for the Clinical Investigation Site

We work with the statistician and the statistician’s randomization code to ensure both the active pharmaceutical ingredient and the placebo are properly blinded to all clinical investigators. We also work with the client to develop the proper labeling and packaging for the study. 

We maintain either name and/or subject ID numbers into our EMR, as requested by the investigators, as a unique group of subjects for the trial. 

This ensures traceability of what the subjects in the trial have received..

We always initiate a non-disclosure agreement (NDA) to keep the clients’ proprietary information confidential.

Challenge

Phase I & II studies are often complex and expensive.

Solution

Take advantage of Town & Country Compounding's 503A research resources at a fraction of the cost of production compared to pharmaceutical manufacturers or 503B facilities.

Why use a 503A pharmacy?

Bring your product to market more quickly and less expensively.

  • Less testing required before product release which:
    • Reduces laboratory testing cost
    • Reduces length of testing time
 
  • The amount of product prepared can be determined by the scope of the study.
  • Allows the flexibility to prepare a number of different dosage, strengths, dosage forms, and routes of administration in response to emerging clinical data without multiplying the cost.
 
  • cGMP testing if requested

503A vs. 503B Pharmacies

  • Unlike 503B facilites,section 503A exempts compounding pharmacies from having to follow the FDA’s cGMP regulations as outlined in 21 CFR Part 211 and 21 CFR Part 210.
 
  • Instead, 503A pharmacies must follow the regulations set by the USP (United States Pharmacopeia) Compounding Compendium and the NF (National Formulary)

How can Town & Country Compounding be valuable in the Research Phase of Clinical Trials?

Why Town & Country Compounding for your Clinical Trials?

Our accreditations place us in the top 1% of compounding pharmacies

Town & Country Compounding utilizes only:
  • State-of-the-art equipment
  • Highest quality ingredients
  • Innovative closing devices
  • Expert & highly trained sterile and non-sterile compounders
 

Contact us for clinical trials and research services at Town & Country Compounding. Ask for clinical trials specialists/pharmacists Kim Hansen, RPh and John Herr, RPh.

Let's Get Started

Whether you require ten doses or thousands of doses for your R&D or clinical trial phase, Town & Country Compounding can deliver! We take pride in working with your team from initial development of the study or trial and through all aspects of the study or trial up until completion.