Ascension Seton Investigational Drug Pharmacy Services (IDPS) team is responsible for coordinating and overseeing the management of investigational drugs for clinical trials, including accurate drug storage, preparation, dispensing, and record keeping.
Mission of Investigational Drug Pharmacy Services
- Ensure excellent patient care through the safe use of investigational medications
- Maintain control and accountability of all research medications in accordance with regulations and institutional standards
- Promote research and development
Support Services & Resources
Ascension Seton Investigational Drug Pharmacy Services (IDPS) team may have a role in evaluating feasibility of new investigational drug studies, protocol development, preparing randomization lists and blinding study medications.
They may also assist with:
- Development of matching placebo
- Drug information
- Patient counseling
- Monitoring medication adherence
- Obtaining drug supplies
- Pre-study visits
- Site initiation visits
- Creating investigational medication order sets
- Building investigational medication order sets into the computer entry system (COMPASS)
- Order entry procedures
- Treatment plan review
- Preparation of written study materials
Training and Orientation
Members of the Investigational Drug Pharmacy staff provide study-specific training for pharmacy staff involved in research protocols. This includes chemotherapy and intravenous preparations of study drug.
Fee Schedules, Budgets, & Billing
The Investigational Drug Pharmacy staff helps determine pharmacy fee schedules and implement billing procedures. They will provide information that may be used when developing a protocol or incorporating pharmacy fees into the study budget. You may request their services directly for a specific study using the Site Approval Tool.
Compounding and Storage Services
Investigational Drug Pharmacy staff shall arrange for study medication admixture services following USP 797 guidelines for compounding of sterile and non-sterile preparations.
This service is provided during regular working hours or after hours/on-call admixture/dispensing of study agents when required. IDPS shall arrange for separate and controlled-access storage areas, ensuring proper storage conditions and temperature monitoring for investigational study drugs.
Eimeira Padilla, Pharm.D., PhD
Ascension Seton Research Pharmacist
Work: 512-324-7000, ext. 74930
Lauren Shelton, CPhT, PhTR
Ascension Seton Research Pharmacy Technician
Work: 512-324-7000, ext. 79099
If you have questions about Ascension Seton Investigational Drug Pharmacy Services, please email us at IDPS@seton.org