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Cognitive Research Corporation Clinical Research Organization

Cognitive Research Corporation Clinical 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 Areas. Services.

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Cognitive Research Corporation Clinical Research Organization

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  1. Cognitive Research Corporation Clinical 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 Areas

  3. 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

  4. 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

  5. Deliverables • 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 • 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

  6. 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

  7. 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 drug-Induced 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)

  8. 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

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