Investigational Drug Service

The Investigational Drug Service (IDS) supports clinical investigations conducted by scientists affiliated with the Yale-New Haven Medical Center. Since its creation in 1983, the service has played a pivotal role in 600 NIH, pharmaceutical industry or Yale-sponsored clinical investigations. The IDS assures all investigations, including emergency IND treatments, are conducted in compliance with federal and local regulations regarding investigational drug use. The IDS is available for all clinical investigations examining the efficacy and/or safety of both novel and existing drug therapies/treatments approved by the Yale University School of Medicine's Institutional Review Board.

IDS services
The service is staffed by at least one clinical pharmacist and a technician with specialized training in the design and conduct of clinical trials.

The IDS can assist investigators with:

• Study design
• Development of IND submissions
• Randomizations
• Blinding methodologies
• Educational materials/in-service training for patients and staff
• Compounding and repackaging of oral, topical and parenteral dosage forms and matching placebo formulations
• Control over investigational drug inventories (including dispensing documentation)
• Maintenance of clinical supplies
• 24-hour-a-day access to randomize, enroll and dispense medications to patients consenting to participate
• Central randomization and drug distribution services for multicenter investigations within and outside the U.S.

Emergency services are available 24 hours-a-day to give investigators access to treatment information and assist with serious adverse event reports.

Facilities
The IDS is located in the hospital's East Pavilion and is open for inspection by all potential investigators and sponsors. Inspections must be scheduled through the IDS coordinator.

All investigational drugs are stored within a specially locked area to limit access by non-authorized personnel. Manufacturing facilities of YNHH Pharmacy Services are used for all extemporaneous compounding of oral, topical and parenteral formulations. The IDS is able to dispense investigational medications to both inpatients and outpatients, including direct mailing to outpatients.

Contact IDS
Routine inquiries (Monday - Friday, 8 a.m. - 4:30 p.m.):
Tel. (203) 688-4872
Fax (203) 688-4890

Urgent inquiries or emergencies (24 hours):
Tel. (203) 688-2978

E-mail: Clinical Coordinator, Sandra L. Alfano, Pharm.D., FASHP
Tel. (203) 688-6446

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Last revised: February 19, 2004 (cfs)

Home page URL: http://www.ynhh.org

All information is intended for your general knowledge and is not a substitute for medical advice or treatment for specific medical conditions. You should seek prompt medical care for any specific health issues and consult your physician before starting a new fitness regimen.