President, CEO
Jeanette E. Ahrens, PhD
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Jeanette completed undergraduate,
graduate and postgraduate degrees in biomechanical engineering
from Tulane University. She has over fifteen years' experience
working in the field of orthopaedic surgery with an emphasis
on total joint arthroplasty and spinal surgery. Dr. Ahrens
has extensive experience in both preclinical evaluation
of materials and devices as well as the clinical evaluation
of devices. She has served as a representative at FDA
meetings during IDE development and has worked closely
with regulatory specialties through many phases of the
clinical study process.
Additionally, she has experienced FDA audits from both
the site and CRO perspective. For Pivotal Research Solutions
Inc, Dr. Ahrens works most closely with clients and their
partners during three phases: [1] the definition of the
clinical protocol through site initiation, [2] the preparation
of any regulatory documents, and [3] the oversight and
resolution of any study or site issues that arise during
the course of the study. |
Human Resources and Marketing Director
Mollie McCune
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Mollie received her undergraduate degree from the University
of Houston (Clear Lake City) and has over twenty-five
years of experience in the administration of medically-related
businesses. During her tenure, she has also developed
skills in marketing and public relations.
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Quality Assurance Manager
Deb Newby
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Deb Newby, CCRC has a strong background in clinical
research and management. At Pivotal Research Solutions,
Deb manages our internal clinical team and the the quality
assurance audits that are performed to ensure proper
conduct and continuous quality improvement of monitoring
visits by Pivotal Research personnel.
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Internal Protocol Compliance Monitors
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Holly Graham
Holly is a Certified Clinical Research Coordinator with
five years’ experience coordinating spine clinical
trials at a high enrollment site. This experience makes
her an excellent resource for site personnel that can
address both regulatory and protocol-specific implementation
questions.
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Meeta Babu
Meeta holds a B.S. in science from Belmont University
and over seven years' experience as a site coordinator
for clinical trials in several specialty areas, including
orthopedics. Her background provides an excellent foundation
for her ability to provide support and assistance to our
study sites and CRAs. |
Clinical Data Specialist
Jennifer Vance
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Jennifer has eight years' experience in computer systems,
software development and data management. She is responsible
for the accurate, timely collection of clinical data.
She develops the quality control systems, manages the
database development for each clinical study, and supervises
the clinical data entry staff.
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Regional Clinical Research Associates
One of Pivotal Research Solutions' top priorities is that
our CRAs have positive experience in site coordination. Only
then can the be prepared to provide customer service and understand
from their sites' perspectives what is needed.
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Tanya Allen -- Midwest
Tanya holds an associate's degree and has a strong background
in data management and all aspects of clinical site
coordination.
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Faye Gardner, CCRP -- Texas/Southeast
Faye holds an LVN and has several years of clinical
site coordination experience.
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Jessica Roussel-- Northeast
Eileen
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Brandee Sowers, CCRC -- Texas/Central US
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Tracy Davison -- Midwest
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