Overview

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

At BCT, we are committed to providing the highest quality data – fast. In all studies we have participated in, we met and in many cases 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.

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 three to four 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: 23 days
• Contract signed: 1 week
• Extensive database, substantial experience with targeted radio, newspaper and other patient recruitment channels

Research Experience

BCT conducts phase 2 to 4 clinical trials in the following therapeutic areas:

• Internal medicine;
• Endocrinology;
• Neurology;
• Urology;
• Dermatology;
• Gastroenterology;
• Psychiatry;
• Pain;
• Obesity; and
• Sexual dysfunction (male/female).

We have conducted more than 200 trials for all major pharmaceutical companies and CROs. the following is a partial list of BCT studies:

• Abdominal pain;
• Acne;
• Anxiety;
• Binge eating disorder;
• Blood collection;
• Chronic pain (back, knee);
• Constipation;
• Depression;
• Erectile dysfunction;
• Elderly anxiety;
• Elderly depression;
• Female sexual dysfunction;
• Fibromyalgia;
• Irritable bowel syndrome;
• Diarrhea/constipation;
• Laser device studies;
• Male sexual dysfunction;
• Migraine;
• Obesity;
• Overactive bladder;
• Postherpetic neuralgia;
• BPH;
• Prostatitis;
• Psoriasis;
• Rosacea;
• Stuttering;
• Seborrheic dermatitis; and
• Tissue collection.

Facility Description

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

• Two patient exam rooms;
• One phlebotomy and lab preparation room;
• Two secure drug storage rooms, locked and professionally monitored;
• One patient bedroom;
• A lounge with snacks and drinks for patients and monitors;
• Two offices for monitors;
• A quiet room for phone interviews and patient questionnaires; and
• A conference room.

Equipment (calibrated annually):

• -20C freezer;
• -35C freezer;
• Four centrifuges;
• One refrigerated centrifuge;
• Two refrigerators for investigational drug storage;
• Medical scale;
• Stadiometer;
• Electronic blood pressure monitor;
• Four sphygmomanometers;
• Medical recliner chair; and
• ECG machine.

Diagnostic Capabilities

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

• Endoscopy;
• MRA;
• X-Ray; and
• 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).

The BCT office is equipped with high-speed, secure Wi-Fi internet.

Safety and Security

Our 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 to access the drug storage rooms.

Investigator Experience

Principle Investigators

Our PIs are active medical practitioners, either in specialized solo practices or partners in well-established group practices. All PIs are board certified and have 12 to15 years of clinical research experience in addition to general medical experience.

Robert Bargar, MD
Director of Internal Medicine

Irina Mezhebovsky, MD
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 in Dermatology Research

Qualifications

All BCT investigators and staff are trained yearly on GCP (certificates available). All study coordinators are HAZMAT certified.

Staff Expertise

BCT clinical coordinators are registered nurses averaging seven years of clinical research experience. Each of the clinical coordinators is fully trained in GCP and HIPAA. 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.

BCT Staff

• Seven clinical study coordinators with experience ranging from three to 12 years;
• Subject recruitment specialist;
• Regulatory coordinator;
• Registered dietitian;
• Nurse practitioner; and
• Lab courier.

Patient Demographics

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

• Less than 30 minutes 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 three-mile radius of more than 100,000 people

BCT has developed and is actively maintaining a patient database of more than 8,000 patients.