a full-service cro specialized in cns and early phase ... · efficient, and our relationship with...
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Presented by Bobbie Theodore, M.S. – [email protected]
A full-service CRO specialized in CNS and early phase product development
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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
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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
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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
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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
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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
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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
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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
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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
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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.
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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
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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
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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
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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
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Bobbie Theodore, M.S.
(916) 803-7149
Contact
Cognitive Research Corporation200 Central Ave, Suite 1230
St. Petersburg, FL 33701www.cogres.com