Investigational Drug Service

The Investigational Drug Service (IDS) offers pharmaceutical services and guidance to support research activities for all research groups and investigators engaged in research. The IDS ensures the delivery of high quality pharmaceutical care by adhering to all laws and regulations while minimizing the risks associated with participation in an investigational drug trial.

IDS Services

Drug Handling & Control

• Ensure drug is stored at the appropriate temperature
• Storage facilities with temperatures ranging from -80 C to room temperature
• Storage areas are under constant temperature monitoring, hard-wired to temperature alarm systems, and tied into the emergency power generators.
• Monitor drug par levels and expiration dates

Record Keeping

• Meet with sponsors and monitors to verify quality assurance
• Maintain accountability records of drug
• Maintain correspondence for drug-related issues

Research Activities

• Provide development, support, and review of protocols for clinical trials and for compassionate use treatment.
• Voting members of IRB

Randomization

• Establish randomization procedures, schemes, and perform subject randomizations as required
• Establish procedures for and perform un-blinding functions

Drug Information and Education

• In-service nursing staff
• Intradepartmental Education
• Adverse drug event reporting

Prepare sterile and non-sterile compounding

• Guidance surrounding laws and other regulations
• Provide blinded medication dosage forms
• Dosage forms prepared include but are not limited to intravenous preps, ointments, solutions, capsules

Fee structure

• There are no charges for services provided: IRB fees cover IDS services.
• If drug is not provided by sponsor, drug is paid for by research group at pharmacy acquisition cost (no mark-up)
• Budgets may be created for multi-center studies in which IDS acts as the primary pharmacy site. Budgets for other sites will request compensation for salary recovery, supplies, medication costs, laboratory testing, and mailing.

Support:

• Assure compliance with FDA, state, and hospital requirements
• Minimize problems with the availability, preparation, and storage of study drugs
• Establish randomization procedures and schemes
• Promote and assure patient safety
• Assist investigators in proper and accurate record keeping.
• Investigational drugs and study-related information are accessible 24 hours a day, 7 days a week

Forms:

Drug and Biologics Form

Emergency/Compassionate Use Guidance

Emergency Use Form

Hours of operations

6:30 AM - 8 PM Mon-Fri
6:30 AM - 5 PM Sat-Sun

Staff

Phone: 617-732-6410
Fax: 617-732-7500

Jon Silverman, PharmD
Supervisor
Pager: 33784
email: jsilverman@partners.org  

Henry Lam, RPh 
Senior Research Pharmacist
Pager: 12011
email: hlam@partners.org  

Alka Patel, PharmD
Senior Research Pharmacist
Pager: 30195
email: apatel11@partners.org

Tricia Kelly, RPh
Senior Research Pharmacist
Pager: 12156
email: pkelly8@partners.org

Hina Alam, PharmD
Senior Research Pharmacist
Pager: 34313
email: halam@partners.org

Vivian Mikhail, PharmD
Senior Research Pharmacist
Pager: 34407
email: vmikhail@partners.org  

Tony Kalleeny, PharmD
Senior Research Pharmacist
Pager: 36765
email: akalleeny@partners.org

Location:

75 Francis Street,
Tower Building, Lower Level 2