Cognitive Research Corporation Clinical 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

Therapeutic Areas

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

Principals and Founders Gary G. Kay, Ph.D., PresidentPresident Thomas J. Hochadel, Pharm.D., Chief Operating OfficerChief Operating Officer 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

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 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

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

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)

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