Transcript Title of Presentation

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 Experience
Phase I, II, and III (500+ patients, multi site programs)
Cohorts, and competitive enrollments
25+ sponsors, small biotechs to large pharmas
Adolescent, adult and geriatric age groups
Oral, nasal inhalation, injectable, transdermal patch, and CPAP drug delivery methods
Indications Phase I - IV
Psychiatry
Addiction (cocaine, nicotine,
opiates, hydrocodone)
Anxiety
Bipolar Disorders
Depression
Mania
Panic Disorder
Schizophrenia
Healthy
Adaptive and umbrella designs
Crossover, pilot, pivotal designs
SAD / MAD
Bioequivalence and bioavailability
Fed, fasted
Healthy overweight and obese
Smokers, non-smokers
PK, PD
EEG, qEEG
QT, QTc
Neurology
ADHD
Alzheimer’s Disease
ALS
Cognition, MCI
Epilepsy
Fibromyalgia
Head Injury
Huntington’s Disease
Multiple Sclerosis
Movement Disorders
Parkinson’s Disease
Spinal Cord Injury
Stroke
Tardive dyskinesia
Tourette’s Syndrome
Pain
Headache, migraine
Neuropathic Pain
Osteoarthritis
Rheumatoid Arthritis
General Medical
Asthma and COPD
Bone/Joint Reconstruction
Cardiovascular
Dermatology
Diabetes
Gastroenterology
Hematology
Immunology
Infections Diseases (+HIV)
Obesity
Ophthalmology
Osteoporosis
Respiratory
Sleep Disorders
Urology
Other
Caffeine
Nutraceutical
PET imaging
Renal Impairment
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
Driving Simulator (CRCDS)
Exclusive partnership with the University of Iowa to equip and manage
driving simulation studies (18+ driving simulator trials completed)
The CRCDS-MiniSim Driving Simulator
State-of-the-art, high performance unit based on
the National Advanced Driving Simulator
A fully standardized, portable, validated driving
assessment platform
Capitalizes on decades of research conducted by
the University of Iowa for the National Highway
Traffic Safety Administration
Uniquely suited for multi-center clinical research
and development
Accurate driving performance data; comparable in
sensitivity to over-the-road-testing
Expeditious, cost-effective, safe solution for
assessing drug-impaired driving
Principals and Founders
Gary G. Kay, Ph.D., President
Thomas J. Hochadel, Pharm.D., COO
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
Founders are core contributors on project deliverables
You will always get the “A Team” from bid to final
Managed over 450 clinical trials across multiple indications
Recognized scientific and operational expertise in CNS clinical trials
Worked on 25+ 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
Experience working with a range of lab, cardiac safety, centralized
rating and other industry vendors
Recent Collaborative Projects
A Phase I, double blind, randomized, multiple ascending dose safety, tolerability and
pharmacokinetics study in patients with schizophrenia on a stable anti-psychotic
regimen (includes qEEG) – 4 cohorts of 10 females (2014)
A Phase II, randomized, double-blind, placebo-controlled trial evaluating the efficacy,
safety, and pharmacokinetic behavior of orally administered XXX in subjects with
drug-Induced Tardive Dyskinesia – multi-site (2014)
A Phase I, open-label, multiple dose study to assess the drug-drug interactions of XXX
with XXX in healthy male subjects – (2014)
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) – Positive data
A Phase I, prospective, randomized, double-blind, placebo-controlled, sequentialcohort, escalating, single-dose study designed to determine the maximum tolerated
oral dose of XXX in healthy, male volunteers – 5 cohorts of 9 (2013) – Positive data
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