Research Portfolio

Types of Phase I studies conducted at BCRC include:

  • First-in-human
  • Safety and tolerability
  • Oral and IV dose-ranging
  • Pharmacokinetics
  • Pharmacodynamics
  • Thorough ECG/QTc
  • Drug-drug interaction
  • Drug-food interaction
  • Bioavailability/bioequivilence
  • IM vaccines/immunoglobulins

Pharmacodynamic Capabilities

Accurate measurement of pharmacodynamic parameters is available, including:

  • Insulin/glucose clamp
  • Cardiac telemetry
  • Holter monitoring
  • Serial ECG and vital sign monitoring
  • Platelet aggregation
  • 24-hour ambulatory gastric pH monitoring
  • Ambulatory blood pressure monitoring

Staff

Every Phase I study is assigned a project management team that maintains an open line of communication with the sponsor. To efficiently manage your protocol, each team consists of a Medical Director, Primary Investigator, Clinical Research Coordinator (CRC), research nurses, technicians, recruiter and a quality assurance auditor. The investigator and CRC provide the sponsor with regular updates on the study progress. This hands-on approach provides a direct link to the sponsor thus assuring the safe and ethical conduct of each aspect of the research protocol.


Charles H. Ballow and Robert A. Blum

Charles H. Ballow, PharmD, FCCP, Executive Director
Robert A. Blum, PharmD, Executive Director

Drs. Charles H. Ballow and Robert A. Blum provide the experience and leadership to direct BCRC in its mission. Each director has over 23 years of experience conducting Phase I-IV clinical trials at an internationally renowned academic research laboratory. Dr. Blum earned a BS in Pharmacy from Albany College of Pharmacy (1983), PharmD from The Medical University of South Carolina (1985) and completed a residency/fellowship at the University of Illinois (1987). Dr. Ballow earned a BS in Chemistry from The University of North Carolina (1979), MS in Pharmacology (1984) and PharmD (1986) from The University of Maryland. They have served as Principal Investigators on hundreds of successful Phase I clinical pharmacology research protocols in healthy volunteers.

The foundation of our mission at BCRC is based on the philosophy that an experienced professional environment leads to high quality research.

Christian D. Lates

Christian D. Lates, MD, Medical Director

Dr. Christian D. Lates has been involved in clinical pharmacology research since 1996 and oversees the medical aspects of all studies. He has extensive experience screening healthy volunteers and monitoring their safety during study conduct. Dr. Lates earned a BA in Biology from Canisius College (1990) and MD at The University of Buffalo School of Medicine (1994). Dr. Lates completed a residency in Internal Medicine (1998) and is Board Certified. In addition to conducting research at BCRC, he maintains an active Internal Medicine practice near BCRC.

Peggy L. Rusert

Peggy G. Rusert, BSN, RN, CCRC, Clinical Operations Director

Ms. Rusert is a Certified Clinical Research Coordinator with more than 20 years experience in coordinating Phase I studies. Peggy demonstrates a strong committment to quality. She works with the project teams and monitors to assure that sufficient attention is given to all aspects of the protocol to maintain the highest level of quality. Peggy has developed many lasting relationships with sponsors. She is responsible for much of BCRC's success and growth.

Commitment to Quality

To assure high-quality research, BCRC follows extensive SOP's based on GCP and ICH guidelines. BCRC has a fully integrated Quality Assurance program that supports quality management from the start to finish of each protocol.

BCRC maintains an extensive employee training program. Documentation of professional licenses, CV's, orientations, SOP training, certification of dangerous goods and OSHA compliance with blood borne pathogens are maintained in each employees's Training and Certification file.

Institutional Review Board

There is no delay in starting a protocol at BCRC since the IRB meets weekly with rapid notification. All IRB correspondence is simultaneously sent to both the investigator and sponsor in accordance with GCP and ICH regulatory guidelines.

Recruitment

Our interactive database allows for rapid identification of volunteer candidates based on specific demographic criteria. All IRB correspondence can be simultaneously sent to both the investigator and sponsor. Protocols can be rapidly filled to meet the needs of the sponsor in a timely and efficient manner. All volunteers are versed in study conduct rules and regulations to maintain the integrity of each protocol.

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Q: Where is the nearest hospital?

A: BCRC is located 3 blocks from a tertiary care hospital.

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