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Cognitive Research Corporation Contract Research Organization offering specialized expertise to fit the unique needs of each client offering specialized.

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Presentation on theme: "Cognitive Research Corporation Contract Research Organization offering specialized expertise to fit the unique needs of each client offering specialized."— Presentation transcript:

1 Cognitive Research Corporation Contract Research Organization offering specialized expertise to fit the unique needs of each client offering specialized expertise to fit the unique needs of each client Bobbie Theodore An Alliance of Quality Research Services

2 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

3 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 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 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

4 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

5 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

6 Principals and Founders Stephen Horohonich, Chief Technical OfficerChief Technical Officer Albert J. Azzaro, Ph.D., Director of Pharmacologic ResearchDirector of Pharmacologic Research Eva M. Kemper, Director of Clinical ProjectsDirector of Clinical Projects Thomas J. Hochadel, Pharm.D., COOCOO Gary G. Kay, Ph.D., PresidentPresident

7 Deliverables Seasoned Team of Professionals Ability To Meet and Beat Timelines Wide Menu of Adaptable Services 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 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 From program development to final analysis to seamlessly fit into your work processes Can provide CRO, or CRO + site service proposals

8 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

9 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, 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) – Positive data

10 Contact Information For inquiries: Bobbie Theodore (916) Cognitive Research Corporation 200 Central Ave, Suite 1230 St. Petersburg, Florida


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