Presented by Bobbie Theodore, M.S. – bobbie@alliancesites.com

A full-service CRO specialized in CNS and early phase product development

CRC is dedicated to building a personal connection with our clients, defined by open communication, mutual

respect, and, above all, a shared vision.

A Seamless Extension of Your Organization

With a unique depth of expertise in CNS populations and healthy subject protocols, the CRC team has decades of

experience in successfully conducting clinical trials.

A Proven Track Record of Success

CRC brings extraordinary creativity to its CRO services and has developed proprietary technologies including a driving

simulator applicable in a broad range of studies.

A History of Innovation

CRC provides services that are comprehensive, flexible, quality-driven, and cost-effective, allowing you to reach

your goals in a timely, highly efficient manner.

A Trusted Partner

Since its inception in 2006, CRC has worked with over 70 sponsors and participated in hundreds of trials.

Neurology/Cognition

Psychiatry

Healthy

Driving

Pain

Other

Study Experience

• 70+ Phase I trials in patient populations

• 50+ SAD and MAD trials in healthy volunteers

• 50+ trials with pharmacodynamic assessments

Phase I ExperienceTherapeutic Experience

Seasoned Team of ProfessionalsYou will always get the “A Team,” from bid to final. Founders are core contributors on project deliverables.

Recognized Scientific and Operational Expertise in Clinical TrialsWith specialists in data management, cognition, and protocol development.

Ability To Meet and Beat TimelinesProactive management of vendors, and extensive experience with protocols and investigator sites.

Relationships with High Quality Sites, and Thought Leaders in Complex Phase I Trial Designs and CNS SpecialtiesCRC has a network of 100+ clinical research site affiliations including movement and memory disorder clinics, imaging centers, sleep labs, a dedicated specialty clinical pharmacology unit, and a licensed, accredited psychiatric hospital.

Wide Menu of Adaptable Services From program development to final analysis, to seamlessly fit in to your work processes.

Key Differentiators

Neurology

Alzheimer’s Disease

ALS

Ataxia

Cognitive Dysfunction, MCI

Epilepsy

Huntington’s Disease

Multiple Sclerosis

Movement Disorders

Parkinson’s Disease

Stroke

Tourette’s Syndrome

Psychiatry

Addiction (cocaine, nicotine, opiates, hydrocodone)

ADHD

Anxiety

Bipolar Disorders

Depression

Obsessive Compulsive Disorder

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

Therapeutic Areas

Sleep

Chronic Insomnia

Excessive Daytime Sleepiness

Narcolepsy

Obstructive Sleep Apnea

Restless Legs Syndrome (RLS)

Sleep Maintenance

General Medical

Asthma and COPD

Cardiovascular

Dermatology

Diabetes

Hematology

Immunology

Infectious Diseases (+HIV)

Obesity

Osteoporosis

Hepatic & Renal Impairment

Urology

Pain/Other

Headache, Migraine

Neuropathic Pain

Osteoarthritis

Pre/Post Surgical Pain

Driving Impairment

Nutraceutical

Therapeutic Areas

Menu of ServicesTrial Design

and Protocol Development

Clinical Trial Management

Data Management

Assist clients with trial designs

All aspects of protocol development including protocol authoring and writing

In-house expertise, and contracted expert panels

Comprehensive project management

Investigator selection and training

Investigator contract negotiation and grant management

Investigator meeting planning and coordination

Clinical trial monitoring

Coordination of Central Lab, imaging (MRI/PET/fMRI), and other specialized biomarkers (EEG/ERPs/ECG/PSG)

Case report form design and printing

Comprehensive database design and validation

Query generation and resolution

Coding

SAE reconciliation

Menu of Services

Randomizations

Statistical analysis plans

Efficacy and safety analyses

Meta analyses

Clinical study reports

IND and NDA development

Investigator’s brochures

Full ICH reports

Manuscripts and abstracts

IND submissions

IRB submissions

Regulatory document management

BiostatisticsMedical Writing

Regulatory Affairs

Menu of Services

Quality assurance audits

Clinical file audits

Investigator site audits

Dose-response studies in cognition, sleep, psychomotor performance, etc.

Driving performance studies

AAMI proof-of-concept studies

Tyramine challenge studies

Trier Social-Anxiety Test paradigm studies

Internationally renowned speakers

Continuing education programs

Invited addresses

Television, radio, and print exposure

Quality Assurance

Behavioral Pharmacology

Media Services

Driving Simulation Solutions

CRC’s customized driving simulator,the CRCDS, was designed to evaluatea wide variety of drugs on drivingperformance in both normal healthyand patient populations.

CRC has deep expertise in the currentFDA guidance related to evaluatingdriving performance.

Leadership

Tom Hochadel, PharmD

CEO

27+ years of clinical trial management experience

Specialized in CNS research, including the areas of Alzheimer’s disease, ADHD, bipolar, cognition, depression, driving simulation, mania, Parkinson’s disease, schizophrenia, and sleep disorders

Worked on 22 INDs (2 as ‘responsible signature’)

Participated in 12 NDAs

Managed over 300 CNS based clinical trials

Unique expertise in Tyramine Challenge Pressor Tests and other Phase I pharmacodynamic studies

Leadership

Gary G. Kay, PhD

President, CSO

More than 75 CNS publications

Delivered hundreds of invited lectures worldwide

Served as Principal Investigator for 20 CNS-based studies

Fellow of National Academy of Neuropsychology, and Associate Professor of Neurology at Georgetown University

Consultant to dozens of pharmaceutical companies, FAA, DOD, NASA, etc.

Board certified clinical neuropsychologist

Provided testimony at multiple FDA hearings

Developer of CogScreen Computerized Test Battery

Internationally recognized expert in driving simulation

TestimonialsCongratulations on meeting the enrollment target on the ***** study today, despite the many challenges faced [COVID-19 pandemic] during the process.

Everyone is very excited with the news and we want to thank you all for your hard work and partnership.

Please extend this note to the CRAs, who have done a fantastic job in ensuring the quality of the trial and working with the sites during this challenging time.

What can I say? You have again exceeded all reasonable expectations. Next chance I get, I will buy you all the beverage of your choice! Thank you!

- Biopharmaceutical sponsor

There really wasn’t any question that CRC was the most qualified entity to run our driving simulation study. The data was clean, technology efficient, and our relationship with CRC personnel was open. They supported us from program design and regulatory interaction to clinical conduct, data interpretation and presentation of results.

- Driving study Sponsor

We chose CRC not only due to price competitiveness. It was important to us that the bid team was the team that we would actually get on our program. That was a deciding factor for us.

- Healthy subject study sponsor

We’ve chosen CRC for multiple programs after our first great experience together on a Phase 1 study. They integrate into our team, communicate efficiently, and allow us to choose which services we need (and which we want to keep in-house). We have worked with a variety of other CROs in our careers so we can compare, and we’re very happy with the services we get from CRC.

- Biotech Sponsor

Apex CollaborationIn response to sponsors’ requests for full-service proposals under one contract, CRC has established relationships with leading

research sites including CNS Research and Hassman Research Institute (HRI), now collectively Apex Innovative Sciences. Apex’s Alliance Early Phase (AEP) partnership offers unique capabilities to accelerate drug development.

CRC partners with CNS Research and HRI to conduct early phase trials as an integrated team when advantageous to sponsors. The collaboration allows for competitive pricing, one-stop contracting, and objective quality monitoring.

• Locations in Long Beach, Torrance, Garden Grove, CA• Long Beach: 40,000 sq. ft., 60-bed Inpatient Unit

• Marlton, NJ: 21,000 sq. ft., 60-bed Inpatient Unit• Berlin, NJ: 12,000 sq. ft., 40-bed Inpatient Unit

CNS Research Hassman Research Institute

Bobbie Theodore, M.S.

(916) 803-7149

bobbie@alliancesites.com

Contact

Cognitive Research Corporation200 Central Ave, Suite 1230

St. Petersburg, FL 33701www.cogres.com