1 / 10

Cognitive Research Corporation Contract Research Organization

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.

malini
Télécharger la présentation

Cognitive Research Corporation Contract Research Organization

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  1. 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

  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 • 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

  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 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

  7. 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

  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 rangeof 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 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

  10. 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

More Related