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Cognitive Research Corporation Contract Research Organization offering specialized expertise to fit the unique needs of each client. Bobbie Theodore clinicaltrials@btheodore.com An Alliance of Quality Research Services. Therapeutic Experience.
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Cognitive Research Corporation Contract Research Organization offering specialized expertise to fit the unique needs of each client Bobbie Theodore clinicaltrials@btheodore.com • 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 • 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 • 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
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 • Stephen Horohonich, Chief Technical Officer • Albert J. Azzaro, Ph.D., Director of Pharmacologic Research • Eva M. Kemper, Director of Clinical Projects • Thomas J. Hochadel,Pharm.D., COO • Gary G. Kay, Ph.D., President
Deliverables • 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
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 rangeof 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 TardiveDyskinesia – 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
Contact Information For inquiries: Bobbie Theodore (916) 939-6696 clinicaltrials@btheodore.com Cognitive Research Corporation 200 Central Ave, Suite 1230 St. Petersburg, Florida 33701 www.cogres.com