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Investigational Drug Service (Penn)

Director: Rockwell, Kenneth A., Jr., PharmD, M.S.

Summary:

The Investigational Drug Service (IDS) is the research pharmacy for the University of Pennsylvania, providing services for clinical and pre-clinical drug and device trials to investigators at all Penn schools, UP Health System hospitals and clinics and affiliated institutions.

The IDS is able to offer a range of services to investigators, from preparation, dispensing and inventory management for inpatient and outpatient trials, to formulation of blinded dosage forms or placebos to match existing medications, randomization tables and blinding schemes, specialized packaging and distribution, as well as limited release testing of finished products. We can assemble draft materials for CMC (IND) submissions or draft language for protocols, describing our activities related to your specific protocol. As a core facility, we pass along our actual costs on an hourly basis for these services. We maintain a highly secure, temperature-controlled facility and an electronic inventory system.

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Services

  • Clinical trial support services ( Support service )

    The Investigational Drug Service provides a variety of support services, including:

    • "Consultation on study design and logistics for students, residents, fellows and young investigators.
    • Research of protocol-related questions using various drug information references.
    • Assistance with IND application development and submission (for manufactured or compounded medications or natural products)."

  • Investigational drug services ( Support service )

    "The IDS is charged with safe and responsible handling of investigational drugs. The purpose of the IDS is to maintain control and accountability of investigational drug use in the Medical Center to promote maximum benefit and safety for patients enrolled in studies.

    Investigational drugs are procured, stored, inventoried, dispensed and used through the IDS in compliance with regulations or guidelines of the FDA, JCAHO, ASHP, Code of Federal Regulations, Pennsylvania State Board of Pharmacy, other applicable organizations and in accordance with Hospital, Medical Center and University policies and guidelines.

    The IDS provides the following services:

    Services provided for all research protocols:
    • Drug procurement.
    • Secure, Monitored Storage [there are specific guidelines for storage/security].
    • Accountability [for all agents received and disbursed, accurate to the individual dose].
    • Preparation [includes sterile preparation if necessary].
    • Labeling and Dispensing.
    • Meets with study team as needed.
    • Meets with sponsor and sponsor's representatives to review protocol and records.
    • 24-hour on-call for study-related issues, including off-hour enrollments, guidance for non-study personnel, emergency unmasking of treatment codes, and guidance on admission of study subjects to non-UPHS institutions or vice-versa.

    Services provided for research protocols involving the hospital inpatient pharmacy:
    • Staff training for pharmacists/technicians.
    • Detailed step-by-step procedures.
    • Routine internal audits of enrollment, accountability and dispensing activity.
    • Assistance to medical and nursing personnel in order entry.

    Services provided as necessary based on the needs of the trial:
    • Randomization tables [and un-blinding envelopes for off-site clinics].
    • Repackaging [e.g. bottles, cartons, boxes].
    • Compliance packaging [e.g. blister cards, unit-of-use containers, special labeling].
    • Sterile compounding or manufacturing [products for human injection or infusion using purified non-sterile ingredients].
    • Non-sterile compounding or manufacturing [over-encapsulation of commercial products, compounding of powders or liquids, placebos, suppositories, etc].
    • Dose adjustment [may include sham adjustments of placebo doses, ordering and evaluation of blood tests, etc, to maintain blinding for rest of study team]."


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Last updated: 2016-05-17T13:32:07.930-04:00

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