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Cognitive Research Corporation Clinical Research Organization offering specialized expertise to fit the unique needs of each client Bobbie Theodore [email protected] An Alliance of Quality Research Services

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Page 1: Cognitive Research Corporation Clinical Research Organization offering specialized expertise to fit the unique needs of each client offering specialized

Cognitive Research Corporation Clinical Research Organization

offering specialized expertise to fit the unique

needs of each client

Bobbie [email protected]

An Alliance of Quality Research Services

Page 2: Cognitive Research Corporation Clinical Research Organization offering specialized expertise to fit the unique needs of each client offering specialized

Therapeutic Areas

Page 3: Cognitive Research Corporation Clinical Research Organization offering specialized expertise to fit the unique needs of each client offering specialized

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 ManagementBiostatisticsMedical WritingRegulatory AffairsQuality AssuranceEarly Drug Development (Phase I, healthy subjects, and specialty populations)Neuro-cognitive testingState-of-the-art driving simulator and expertise

Page 4: Cognitive Research Corporation Clinical Research Organization offering specialized expertise to fit the unique needs of each client offering specialized

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

Page 5: Cognitive Research Corporation Clinical Research Organization offering specialized expertise to fit the unique needs of each client offering specialized

Deliverables

Seasoned Team of

Professionals

Ability To Meet and Beat Timelines

Wide Menu of Adaptable Services

You will always get the “A Team” from bid to finalFounders are core contributors on project deliverablesManaged over 450 clinical trials across multiple indicationsRecognized scientific and operational expertise in CNS clinical trialsWorked on 24 INDsParticipated 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 goalsRelationships with high quality sites assists sponsors in successful site selectionProactive management of vendors

From program development to final analysis to seamlessly fit into your work processesCan provide CRO, or CRO + site service proposals

Page 6: Cognitive Research Corporation Clinical Research Organization offering specialized expertise to fit the unique needs of each client offering specialized

RelationshipsCollaborative 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

Page 7: Cognitive Research Corporation Clinical Research Organization offering specialized expertise to fit the unique needs of each client offering specialized

Recent Collaborative ProjectsA 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)

Page 8: Cognitive Research Corporation Clinical Research Organization offering specialized expertise to fit the unique needs of each client offering specialized

Contact Information

For inquiries: Bobbie Theodore(916) [email protected]

Cognitive Research Corporation200 Central Ave, Suite 1230St. Petersburg, Florida 33701www.cogres.com