405 Heron Drive Suite 200
Swedesboro, NJ 08085
Ph 800.331.8272
www.wedgewoodpharmacy.com

Compounding Pharmacy Services for Clinical Trials and Investigational Research

“It has been a great pleasure to work with you and your colleagues during the past six years. You provided critical, seamless support to this study. It is also because of your professionalism and experience that we successfully got to the end. So, thank you. I will certainly keep you in mind should another opportunity to collaborate with you arise.” Emilia Bagiella, Associate Professor of Clinical Biostatistics, Columbia University Mailman School of Public Health.

Research scientists have unique needs.

Clinical trials and investigational pharmaceutical-research place unique demands on you — and your service providers. You require sophisticated customization, quality control and documentation services, in measures that may be far too small for contract manufacturers — and far too large for pharmacies that do not have the technical sophistication, equipment, quality control and turnaround time that scientific research requires.

Wedgewood Pharmacy is positioned perfectly to serve your needs as a research professional. We are one of the largest compounding pharmacies in the United States, and we dispense custom-compounded preparations to more than 25,000 prescribers and their patients in human and animal health. And we know how to meet the needs of doctors and scientists like you.  If you want to speak with someone right away about your needs, call Melissa Buggy, research account specialist, at 856.832.1351.

Wedgewood Pharmacy is a unique resource for research scientists.

Because of this experience, we are a unique resource for ...

• Medical schools;
• Teaching hospitals;
• Veterinary schools; and
• Universities and research institutions

... that are conducting clinical trials and investigational drug studies, and investigating novel uses of drugs. (Veterinarians turn to us, too, for the custom-compounded medications they need to maintain large research-animal populations.)

By investing tens of millions of dollars in facilities, equipment and expertise since 1981 and through our own pioneering dosage-form developments, we are unmatched in the nation as a full-fledged partner in your clinical trials and investigational research.¹

Your unique requirements for investigational pharmaceutical research are perfectly matched by our facilities, equipment, capabilities, experience and expertise. Our pharmacists and pharmacy technicians are devoted exclusively to compounding. They are supported by a team of customer care specialists, all certified through a state-approved examination. We employ state-of-the-art technology in every aspect of our operations in our 40,000 square-foot facility.  

We take our role as healthcare providers and innovators as seriously as our clients do.

Research scientists turn to Wedgewood Pharmacy for unique services and unparalleled support.

We understand that a single error in communication or distribution, for example, could cost your institution precious time, participants or research funding. When you engage us as a partner in your research, a senior member of our Clinical Trial and Investigational Research Support Team will work directly with you to meet your specific requirements for single-site, multi-center, blind, double-blind, open label and other protocols, acting as your dedicated liaison with our development, quality control, compliance, documentation, compounding, distribution and customer-care teams.

From creating tableted placebos, to compounding your Active Pharmaceutical Ingredients (APIs) into any number of dosage forms, through destruction and documentation of unused study materials, we offer a full complement of services to support virtually any research protocol. These include:

Dosage Forms

We prepare and deliver custom-compound APIs or placebos in these dosage forms. (More than 30 flavors also are available.)

Quality Control

We’re meticulous about every custom compound we dispense. Our stringent quality control programs ensure that every dose meets the specifications and highest standards of the pharmacy profession and your research protocols. We’re committed to the strict requirements of Chapters <795> and <797> of the U.S. Pharmacopoeia for compounding non-sterile and sterile preparations. And each compounded preparation we dispense undergoes at least five pharmacist-checks to ensure quality and accuracy.

Wedgewood Pharmacy shares your demand for documentation.

Compounding pharmacy depends on meticulous documentation. Sound familiar? As specialized pharmacists, we understand your documentation requirements and why you have them. 

Our documentation services for clinical trials and investigational studies include:

• Certificates of analysis for chemical ingredients
• Compounding instructions
  • & Ingredient details, including weight, manufacturer, lot number and chemical expiration date
• Process and equipment calibration
• Master formula and lot-specific-records including:
  • Product name or number
  • Study identification name or number
  • Dosage strength
  • Dosage form
  • Ingredient names and quantities
• Material Safety Data Sheets (MSDSs)
• Original study specifications
• Quality control records
• PProcess validation for aseptic fill, sterilization, depyrogenation and batch compounding
• Validation of testing methods (endotoxin, sterility, potency)

Ask These Questions About Quality.

When so much is at stake, it’s important to choose a compounding pharmacy you can trust with your reputation. When you select a compounding pharmacy to partner with your research, be sure to ask questions like these.

We answer “yes” to every one:

• Are you committed to compliance with the USP <797> guidelines for sterile compounding? Have you completed a <797> gap analysis?/li>
• Would you know if you are having a problem with your clean-room or aseptic-compounding environment? If you are compounding sterile preparations, do you conduct weekly lab-tests of air and surface samples in your clean room and other controlled environments?
• Is the air quality in your sterile compounding lab engineered for HEPA filtration to reduce particulates?
• Do you obtain independent, routine certifications of your clean rooms and laminar airflow hoods?
• Do you perform daily monitoring and documentation of your clean-room temperature and humidity?
• Is your staff properly trained and evaluated in aseptic manipulation skills, gowning technique and clean-room use?
• Do you filter (0.2 micron) in a Class 100 (ISO 5) laminar airflow hood contained in a Class 1000 (ISO 6) clean room, or autoclave where appropriate, to achieve sterility?
• Do you perform sterility testing according to USP <71> — Sterility Tests and USP <85> — Bacterial Endotoxin (Pyrogen) Test?
• Do you perform post-filtration filter-integrity testing?
• Do you have systems in place for handling complaints and investigating sterility failures and adverse events?
• In the event of a sterility failure, complaint or adverse event, do you have a procedure in place for determining and conducting a recall, if necessary?
• Do you purchase pharmaceutical-grade chemicals (USP, NF equivalent) from FDA-registered suppliers?
• Do you obtain Certificates of Analyses for all formula ingredients?
• Do you maintain both master formulas and lot-specific worksheets for all compounds?
• Can you immediately trace a prescription back to the original formula log-sheet and the source of ingredients?
• Is every step of the compounding process from prescribing to compounding and labeling through dispensing reviewed and verified by a licensed pharmacist?
• Do you verify the potency of finished compounds through weight, volume and yield checks?
• Do you perform pH testing on injections, ophthalmic preparations and other compounds?
• Do you perform HPLC verification on selected formulations?
• Are your pharmacists, technical and customer care staff dedicated to compounding?
• Does the pharmacy have adequate liability insurance?
• Are you active members of the American College of Apothecaries and the International Academy of Compounding Pharmacists?

Turn to Wedgewood Pharmacy to support your research.

• Assigned liaison with our Clinical Trial and Investigational Research Support Team
• No obligation price quotation to facilitate the Internal Review Board (IRB) approval process
• Blind or open labeling of study drugs and placebos
• Specialized packaging, such as blister packs, to improve participant compliance
• Assembling clinical-trial patient instruction kits (if required)
• Return and environmentally sound destruction of unused preparations

If we have not listed a compounding-related or research-support service that you require, please contact Melissa Buggy, research account specialist, at 856.832.1351 or Renee Lupo, R. Ph, F.A.C.A., F.A.C.V.P., technical-services pharmacist at 856.832.1314.

Please accept our invitation.

We invite you to take a tour of our exceptional facilities and laboratories and to meet with our Clinical Trial and Investigational Research Support Team to discuss — and plan to provide for — your unique needs. Please telephone Renee Lupo, R. Ph, F.A.C.A., F.A.C.V.P., technical-services pharmacist, at 856.832.1314 to arrange your visit.

1 Wedgewood Pharmacy is licensed and regulated as a pharmacy. We are committed to the strict requirements of Chapters <795> and <797> of the U.S. Pharmacopoeia for compounding non-sterile and sterile preparations. However, as a pharmacy creating custom-made medicines, we are not a manufacturer and are thus not required to be cGMP compliant. Clinical trials supporting new drug applications typically require that suppliers of APIs and placebos be cGMP compliant.