Overview

Boston Clinical Trials (BCT) is an independent multi-specialty women-owned/operated clinical research center.

At BCT, we are committed to providing the highest quality data – fast. In all studies we participated, we met, and in many far exceeded, enrollment targets. Internal quality control and close cooperation with study monitors have earned us the highest quality marks from the sponsors who work with us.

Therapeutic Areas
We have conducted over 200 studies for all major pharmaceutical companies and CROs. We specialize in the following therapeutical areas:

• Internal Medicine
• Neurology
• Urology
• Dermatology
• Psychiatry
• Pain
• Obesity
• Sexual Dysfunction (Male/Female)

Partial List of Studies BCT Conducted

Quality Control
We are committed to the highest data quality standards. Since BCT is typically one of the highest enrollers, we are audited by Sponsors/CROs at least 3-4 times every year - with only minor (if any at all) findings. BCT was audited by FDA in April 2006 - with NO findings

Efficiency

• Always use central IRB
• Preparation of regulatory documents: 2-3 days
• Contract signed: 1 week
• Extensive database, substantial experience with targeted radio-, newspaper-, and other patient recruitment channels

Experience

Boston Clinical Trials conducts Phase II - IV trials clinical trials in the following therapeutic areas:

• Internal Medicine
• Endocrinology
• Neurology
• Urology
• Dermatology
• Gastroenterology
• Psychiatry

We have conducted trials for all major pharmaceutical companies and CROs.

Facility

Newly renovated 5,000 sq.ft. facility specially designed for clinical research. In addition to study coordinators’ rooms, BCT has:

• 2 Patient Exam rooms
• 1 Phlebotomy and Lab preparation room
• 2 secure Drug Storage rooms, locked and professionally monitored
• 1 Patient Bedroom
• A Lounge with snacks and drinks for patients and monitors
• 2 Offices for monitors
• A Quiet room for phone interviews and patient questionnaires
• A Conference room

Equipment (calibrated annually)

• -20C freezer
• -35C freezer
• 4 centrifuges
• 1 Refrigerated centrifuge
• 2 refrigerators for Investigational drug storage
• Medical scale
• Stadiometer
• Electronic Blood Pressure Monitor
• 4 Sphygmomanometers
• Medical recliner chair
• ECG machine

Diagnostic capabilities
BCT has established effective working relationships with providers of the following diagnostic services:

• Endoscopy
• MRA
• X-Ray
• Ultrasound

Systems/Technical
BCT is utilizing paper source documents for all studies. All data is entered electronically in Sponsors’ electronic systems. BCT staff is certified to use most electronic data collection systems, i.e., In-Form, Oracle, Medidata, Rave.

BCT office is equipped with high-speed, secure Wi-Fi Internet

Safety and Security
The entrance doors are equipped with electronic locks which are operated by assigned electronic Key Cards. Security cameras are installed on all floors and around drug storage rooms.

All BCT visitors (including monitors and auditors) are required to sign in. Study subjects are never left unattended on BCT premises and are escorted out of the study rooms at the end of appointments.

Only designated staff members have security codes access the drug storage rooms.

Investigator

Principle Investigators and Staff

Principal Investigators are active medical practitioners, either in specialized solo practices or partners in well-established group practices. All PIs are Board-certified and have 12-15 years of clinical research experience in addition to general medical experience.

Robert Bargar, M.D.
Director of Internal Medicine

Irina Mezhebovsky, M.D.
Director of Psychiatry Research

Carmel Heinsohn, MD
Investigator in Psychiatry Research

Arkadiy Stolyar, MD
Director of Psychiatry/Neurology

Luba Rosen, MD
Pain Specialist

David R. Staskin, MD
Director of Urology

Brian Lester, MD
Investigator, Dermatology Research

BCT Staff

• 7 Clinical Study Coordinators with experience ranging from 3 to 12 years
• Subject Recruitment Specialist
• Regulatory Coordinator
• Registered Dietitian
• Nurse Practitioner
• Lab courier

Qualifications:
All BCT Investigators and staff are trained yearly on GCP (certificates available)
All study coordinators are HAZMAT certified

Staff

BCT Clinical Coordinators are Registered Nurses averaging 7 years of clinical research experience. Each of the Clinical coordinators is fully trained in GCP and HIPPA. As a rule, Clinical Research Coordinators work on no more than two trials at a time. This ensures thorough preparation, rapid patient recruitment, practically around the clock availability to patients and monitors, and timely document submission.

Patients

BCT is located in the center of the popular Roslindale Square neighborhood of the City of Boston

• Less than 30 min from Logan Airport, close to all Boston amenities
• 1.5 miles from Faulkner Hospital
• Abundance of public transportation
• Free parking for those who drive
• Population within a 3-mile radius is over 100,000 people

BCT has developed and is actively maintaining the patient database of over 8,000 patients.