Transcript Title of Presentation - Clinical Trial Centers Alliance

Cognitive Research Corporation
Contract Research Organization
offering specialized expertise to fit the unique
needs of each client
Bobbie Theodore
[email protected]
An Alliance of Quality Research Services
Therapeutic Areas
Services
Cognitive Research Corporation (CRC) is a boutique, full-service CRO with decades
of clinical trial experience. CRC specializes in conducting drug, device, and
nutraceutical trials from early development to final analysis.
Trial Design (Phase I-IV)
Clinical Trial Management
Established Network of Investigators
Data Management
Biostatistics
Medical Writing
Regulatory Affairs
Quality Assurance
Early Drug Development (Phase I, healthy subjects, and specialty populations)
Neuro-cognitive testing
State-of-the-art driving simulator and expertise
Principals and Founders
Gary G. Kay, Ph.D., President
Thomas J. Hochadel, Pharm.D., Chief Operating Officer
Stephen Horohonich, Chief Technical Officer
Albert J. Azzaro, Ph.D., Director of Pharmacologic Research
Eva M. Kemper, Director of Clinical Projects
Deliverables
Seasoned
Team of
Professionals
You will always get the “A Team” from bid to final
Founders are core contributors on project deliverables
Managed over 450 clinical trials across multiple indications
Recognized scientific and operational expertise in CNS clinical trials
Worked on 24 INDs
Participated in 17 programs that led to regulatory approvals
Ability To Meet
and Beat
Timelines
Extensive experience with protocols and investigator sites allows us to
manage data and enrollment to meet or exceed sponsor goals
Relationships with high quality sites assists sponsors in successful site
selection
Proactive management of vendors
Wide Menu of
Adaptable
Services
From program development to final analysis to seamlessly fit into your
work processes
Can provide CRO, or CRO + site service proposals
Relationships
Collaborative relationship with thought leaders in CNS specialties
including schizophrenia, depression, ADHD, sleep medicine,
movement disorders, cognition, healthy subjects for protocol
development and feedback
CRC has a network of 100+ clinical research sites with affiliated
movement and memory disorder clinics, imaging centers, sleep labs,
dedicated phase I unit and psychiatric inpatient facilities
Structure allows for stand alone CRO proposals, or services bundled
with leading research sites based on sponsor’s preference
Exclusive partnership with the University of Iowa to equip and
manage state-of-the-art driving simulation studies
Experience working with a range of lab, cardiac safety, centralized
rating and other industry vendors
Recent Collaborative Projects
A Phase I, prospective, randomized, double-blind, placebo-controlled, sequential-cohort,
escalating, single-dose study designed to determine the maximum tolerated oral dose of
XXX in healthy, male volunteers – 5 cohorts of 9 (2013)
A Phase I, double blind, randomized, multiple ascending dose safety, tolerability and
pharmacokinetics study in patients with schizophrenia on a stable anti-psychotic regimen
(other than XXX) – 4 cohorts of 10 (2013)
Phase I, randomized, double-blind, placebo-controlled, sequential dose escalation cohort
study to evaluate the safety, tolerability, and pharmacokinetics of XXX in psychiatrically
stable schizophrenia subjects – 3 cohorts of 16 (2013)
A Phase II, randomized, double-blind, placebo-controlled trial evaluating the efficacy,
safety, and pharmacokinetic behavior of orally administered XXX in subjects with drugInduced Tardive Dyskinesia – selection in process
A Phase I, single-center, randomized, double-blind, 2-way crossover bioequivalence study
comparing XXX with XXX in healthy subjects, male and female subjects– Proposal, 2
cohorts of 20 (2014)
A Phase I, open-label, multiple dose study to assess the drug-drug interactions of XXX with
XXX in healthy male subjects – Proposal (2014)
Contact Information
For inquiries: Bobbie Theodore
(916) 939-6696
[email protected]
Cognitive Research Corporation
200 Central Ave, Suite 1230
St. Petersburg, Florida 33701
www.cogres.com