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Biologics Consulting Group, Inc.
is pleased to make the following announcement:
Dr. Annie McElderry Zurbay joined Biologics Consulting Group, Inc. (BCG) as a Consultant in January, 2005.
Dr. McElderry received a BA in Fine Arts from the University of Maine in 1989, a Doctorate in Nursing from the University of Colorado in 1999 and a Masters Degree in Nursing from the University of Colorado Graduate School Family Nurse Practitioner Program in 2001. In 1999 she joined the faculty of the University of Colorado School of Nursing as a Clinical Instructor, teaching Bachelors- and Doctoral-level students in an outpatient clinic and supervising residents. In 2001, Dr. McElderry joined the University of Colorado School of Medicine where she was a Nurse Practitioner and Professional Research Associate in the Pulmonary Hypertension Practice. In 2002, she began work in the pharmaceutical industry as a Clinical Safety Specialist with Ribozyme Pharmaceuticals in Boulder, Colorado. Dr. McElderry was most recently with OSI Pharmaceuticals in Boulder, Colorado where she was the primary Drug Safety Associate on three product development teams and participated in the pivotal trial and successful registration effort related to a newly-approved, targeted oncology drug.
Dr. McElderry's professional responsibilities have included pharmacovigilance work with drugs in Phases I through III of development in the areas of oncology, hepatology, gastroenterology and cardio-pulmonary medicine. Her expertise includes the global management of clinical trial safety data, from planning to review, coding, database reconciliation and query generation, and the training and supervision of clinical trial Investigators and Study Coordinators in the area of Clinical Safety. She has assisted in the preparation of a variety of regulatory and study-related documents including IND Safety Reports, IND Annual Reports, Investigator Brochures, consent forms, clinical study reports and protocols. Dr. McElderry is experienced in the preparation and submission of regulatory safety reports worldwide, and is an EMEA-trained user of the Eudravigilance database. She is a member of the Drug Information Association and the American Medical Writer's Association.
As a Consultant at Biologics Consulting Group, Dr. McElderry will utilize her clinical, regulatory, and pharmacovigilance expertise to assist clients in the following areas of clinical drug development:
- Providing
pharmacovigilance and risk management planning and review services
for drugs and biologics in all phases of development
- Setting
up safety databases and data collection systems for the capture
of adverse event information
- Providing
ongoing review, oversight and management of clinical trial safety
data
- Creating
and submitting expedited and periodic safety reports and related
regulatory reports worldwide
- Submitting
Medicinal Product Reports and Individual Case Safety Reports to
the Eudravigilance database
- Performing
medical review, coding and clinical trial data auditing services
- Working
with the clinical team to assist clients in the planning and conduct
of clinical trials
- Assisting
in the design of clinical study protocols, case report forms,
serious adverse event forms, and other study-related materials
according to GCPs and the relevant FDA regulations
- Acting
as a liaison between clients and CROs to ensure the timely and
accurate capture of clinical trial data and providing project
management services
- Providing
Investigator and Study Coordinator training and supervision related
to adverse event reporting, clinical trial data collection and
GCPs
- Authoring
and reviewing documents including SOPs, Investigator Brochures,
IND Annual Reports and Clinical Study Reports
View Dr. Zurbay's Curriculum Vitae...
Page Updated April 13, 2010