Specialized compounding for clinical trial medications and research

Clinical Trial Medications and Specialized Preparations

Boulevard Pharmaceutical Compounding Center has experience in the preparation of medications for clinical trials and specialized preparations. We will facilitate the processing of quantities desired in blinded or open-label formats of the study medication. We are able to achieve this in various forms, including capsules, sterile injections, sterile preservative-free eye drops, nasal sprays, transdermal creams and gels, topical sprays, suppositories, and sublingual drops. If you need additional variables in drug delivery, our team will work with you to address the challenges you face in these critical research study situations. We custom-compound medication forms with active or placebo dosage forms. Our compounding services extend beyond clinical studies to include custom pet prescriptions in Boston, Massachusetts, handled with the same precision and quality standards.

We can provide these medications in inpatient trial kits with patient information or other required documentation. For blinded trial medications, both the study medication and placebo will be appropriately labeled for the study coordinator's key reference.

CRITERIA FOR CLINICAL TRIALS

All formulas and samples must be designated “For Investigational Use Only”.
The master formula should include:

  • Product name or number (NIH)
  • Study the identification name or number
  • Dosage strength
  • Dosage form
  • Ingredient name and quantity
  • Total theoretical weight if applied
  • Approval date and signature

Compounding record (all that is in the master formula record):

  • Compounding instructions
  • Ingredients
  • Weight
  • Manufacturer
  • Lot numbers
  • Expiration dates
  • Order of addition
  • Equipment used
  • Temperature is important
  • Mixing speeds and times
  • Storage conditions
  • Test results, if needed
  • Certificate of analysis on all ingredients
  • MSDA if applicable
  • Calibration test on equipment

FREQUENTLY ASKED QUESTIONS

This FAQ section covers common inquiries about compounding services for clinical trials, from compliance to customization.
How is accuracy ensured in compounded clinical trial medications?
Accuracy is maintained through validated processes, ingredient testing, calibrated equipment, and detailed compounding records.
Can placebo and active medications be compounded for blinded studies?
Yes. Both active and placebo versions can be compounded and appropriately labeled to support double-masked or single-masked trials.
What types of dosage forms are commonly prepared for trials?
Capsules, eye drops, nasal sprays, sterile injectables, suppositories, and transdermal creams are frequently compounded for trials.
What labeling standards apply to investigational medications?
Each medication is labeled with clear identifiers and marked “For Investigational Use Only” in line with regulatory expectations.
How is documentation handled during the compounding process?
Each preparation includes a master formula, compounding record, equipment calibration logs, and certificates of analysis for every ingredient.
Is special packaging available for clinical trial medications?
Blister packs with pre-loaded dosing schedules can be arranged to support study-specific timelines and dosing intervals.
What determines the pricing for trial medication compounding?
Pricing is based on the complexity of the study and the number of pharmacist and technician hours required.

Notes: Precautions, safety issues, measures taken in adverse events.
Packaging: Blister pack dosage cards of 30 or 60 capsules with weeks/months dosages pre-loaded may be added to the study.

Pricing: Based on individual study and dependent on Pharmacists' hours and certified techs' hours needed to complete the study.

Still have questions or concerns? Contact our pharmacist today for more information.

Get Medication That Fits You, Not the Other Way Around

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