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..
- Reducing costs
- Improving efficiency
- Increasing flexibility
- Reducing production
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)
Compounding in Research Phase of Clinical Trials
PCAB & ACHC Accredited Pharmacy
Why Town & Country Compounding for your Clinical Trials?
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/pharmacist John Herr, RPh.
We are the highest quality compounding pharmacy for clinical trials.
Town & Country Compounding is a 503A PCAB/ACHC accredited sterile and non-sterile compounding pharmacy lab. We are USP 795 and 797 compliant as well as USP 800 compliant for both USP 795/797 (sterile and non-sterile compounding labs).
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.
High-tech state-of-the-art cleanrooms and labs
USP 797 and USP 800 Compliant Cleanrooms (sterile), USP 795 and USP 800 Compliant labs (non-sterile)
Sterile & Non-sterile compounding
We hold the highest national accreditation for compounding pharmacies.
PCAB /ACHC Accredited
Certified ISO-class cleanrooms ensure every sterile compound is free from contamination.
Do you know where your clinical trial compounds are made?
Behind every successful clinical trial lies high standards, and cutting-edge technology.
Town & Country Compounding’s state-of-the-art, PCAB & ACHC Accredited laboratories have enhanced capabilities to facilitate advanced research.
Take a tour of our high-tech sterile and non-sterile compounding labs.
Compounding Medications for Clinical Trials Overview
Discover how Town & Country Compounding contributes to the critical phases of clinical trials, from formulation development to stability testing, and how these efforts support groundbreaking medical advancements. Whether you’re involved with clinical trials (within USA or International), this video will provide you with a unique perspective on the challenges and innovations in the field.
Compounding Medications for Clinical Trials Overview
What Types of Companies Need Clinical Trials?
Compounding for Clinical Trials- What is a Dry Run/Wet Run?
What Types of Medications we Compound for Clinical Trials
Town & Country Compounding Follows Very Strict Standards
The Work Town & Country Compounding Does in Clinical Trials. Phase O,I,II
We Compound Medications for International Clinical Trials