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
Town & Country Compounding can provide the necessary flexibility, variation, and customization by providing:
- A range of medication strengths
- Various dosage forms
- Various routes of administration
- Various excipients
- Blinded or unblinded product
- Commercial product blinded to investigator and subject
- Smaller batch sizes
Clinical Trial Research and Development
Town & Country Compounding has years of experience with clinical trials. We have helped with the development of IND, NDA and ANDA drugs.
Town & Country Compounding Pharmacy is often asked to participate in drug research and development phase. This may include developing new drugs or using new combinations or doses of existing drugs.
We work with pharmaceutical company, university, and others in this initial research phase to ensure the stability, delivery method, concentration, dosage, pH, packaging, labeling, quality, and accuracy of the drug being studied prior to proceeding to the different phases of the clinical trial.
Clinical Trials
- Phase 0
- Phase 1
- Phase 2
We participate in studies and clinical trials with many types of active ingredients, combination drugs, and various dosage forms including but not limited to:
- Sterile drugs used in IV’s (parenteral medications)
- Vials
- IV bags
- Prefilled syringes
- Oral medications
- Delayed release capsules
- Immediate release capsules
- Alternative bases for drugs to achieve better active drug delivery
- Sterile ophthalmic drugs
- Sterile bladder irrigations
- Nasal sprays and irrigations
- Topical creams and gels
International Clinical Trials
Decades of Expertise
With a proven track record and extensive clinical trial experience, we’re proud to bring our expertise to different parts of the globe.
- Australia
- Japan
- United Kingdom
- Honduras
- India
- Dijbouti
We first established a strong foundation in helping clients with clinical trials within the United States.
This involved gaining expertise in regulatory compliance, patient recruitment, trial design, data collection, and analysis. Town & Country Compounding has built a team of experienced professionals, including pharmacists, researchers, clinical coordinators, and regulatory experts.
Regulatory Expertise
Before expanding internationally, the pharmacy gained a solid understanding of the regulatory landscape in the US. To compound for international clinical trials, we work with contacts in the target countries to understand their regulatory landscape. This includes knowledge of local laws, regulations, and guidelines governing clinical trials, import/export of investigational drugs, and patient rights. Collaborating with regulatory consultants or experts in each target country is advisable.
Partnerships and Collaborations
We have established partnerships with local research organizations, hospitals, and academic institutions in the US to gain experience and can use our experience in various countries. These collaborations have provided access to facilities and experienced personnel. Local partners can also offer insights into cultural and logistical considerations that may impact the trial.
Logistical and Operational Planning
We account for logistical challenges related to drug shipment, storage, and distribution across borders. Language barriers, time zone differences, and potential travel requirements are all things we have experienced. Efficient communication channels have been key to our success with this.
Adaptation to Cultural and Ethical Differences
Different countries have diverse cultural norms, healthcare practices, and ethical standards. We research how to adapt and align with local values and regulations. This ensures that the trials are conducted ethically and in compliance with local expectations.
Quality Control and Assurance
Maintain consistent quality control across international trials to uphold the pharmacy’s reputation and the validity of trial results. Implement monitoring mechanisms to ensure compliance with protocols and regulations.
Knowledge Sharing and Learning
As our pharmacy gains experience from compounding for international trials, we continue to refine our processes and share knowledge across our organization. We regularly update the team’s understanding of international regulations and best practices through training and professional development.
Continuous Improvement
After completing international trials, we gather feedback and insights to improve future endeavors. We have incorporated lessons learned into future trial planning and execution.
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.
Premium Laboratories for Clinical Trials
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).
Our new pharmacy with state-of-the-art compounding laboratories is designed to enhance our capabilities in working with clinical trials.
Our Pharmacy Management Team has completed training in Good Clinical Practice
Good Clinical Practice (GCP) Certifications
Why choose Town & Country Compounding for Clinical Trials?
- PCAB /ACHC Accredited
- Sterile & Non-sterile compounding
- 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)
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