SlideShare a Scribd company logo
1 of 16
Download to read offline
Your Partner for Co-Innovation
1
2
We have the experience you need!
3
Unparalleled Regulatory Guidance >> to ensure unhindered FDA/EPA/OECD acceptance
Specialized Expertise & Facilities >> to conduct studies effectively
Small & Large Animal Species>> to customize studies & meet unique needs
Depth of Experience >> to conduct studies efficiently and humanely
Responsive Updates & Feedback >> to provide guidance for mid-course adjustments
We treat your project like it’s our own
Comprehensive guidance from start to finish
4
Experienced study
directors involved
throughout
Expert protocol
development process
Accelerated IACUC
Approval
Able to meet aggressive
timelines
Large library of
standard studies
Standardized reporting
methods
Continuous study
progress updates
Experienced
Regulatory Review
CAPABILITIES
Diverse Customized Studies
5
Well-rounded experience we can leverage
 Over 150 years of combined experience conducting
toxicology studies
 Distinguished IACUC Committee involvement (to
deliberate and approve projects on ongoing basis)
 Track Record of Receiving Approval for Several IND &
NDA Enabling Studies
6
Wide range of capabilities
■ PK/MTD to DART studies
■ Custom Medical Device preclinical studies
■ 510K to IND/IDE submission regulatory guidance
■ IND/NDA Enabling studies
■ Multi-functional capabilities spanning in vivo models, surgeries, clinical
and histopathology
7
Capabilities (cont.)
 Behavioral Evaluation: FOB Analyses &
Maze Testing
 Modern, fully-equipped veterinary
surgical suite
 Imaging Equipment CT Scanner, C-ARM &
Dexascan
 24/7 Video Monitoring
8
OUR ANIMALS
Diverse Animal Species From Small to Large
9
Outdoor Pastures - Large Farm Animals, Equine to Swine
Indoor Facilities – Rodents to Dogs
10
Species of focus (GLP & non-GLP)
 Acute to chronic toxicity
 Pharmacokinetic / Toxicokinetic
models
 Reproductive/ developmental
toxicology
 Special models (arthritis,
respiratory, in-vivo
biocompatibility)
 Ocular Implants
 Dermal sensitivity
 Acute/chronic toxicity
 Pharmacokinetic / Toxicokinetic
models
 Surgical device development
 Feed/nutrition
 Wound Healing
11
 Acute to chronic toxicity
 Pharmacokinetic / Toxicokinetic
models
 Surgical models
 Gait analysis
 Efficacy
 MTD
SMALL LARGE
S
t
u
d
y
T
y
p
e
s
Mice, rats, ferrets, rabbits, hamsters,
guinea pigs, etc.
Dogs, cats, horses, etc. Porcine, Equine, Bovine, Ovine, Poultry, etc.
Case studies -- Devices
■ Pulmonary Devices to Treat Emphysema
■ Tissue Adhesives & Wound Healing
■ Cardio-Vascular Stents
■ Surgical Devices Development
■ Ocular Implants
■ Muscular Implants
■ Ablation Devices (Liver, Lung, Bladder)
Case studies - Drugs
■ Neurotropic Drug – DART/NDA Enabling, allowed Phase-3 Clinical
Trials
■ Ophthalmic Biologic- Resulted in Approval of Phase-2 Clinical Trials
with Minimal Testing
■ Nasal Delivery
■ Ocular Drug Delivery
■ IBD Models
■ 5 Different Drugs for Separate Clients Taken off Clinical Hold
13
CSU Department of Lab Animal Resources
 CARE & CSU LAR Relationship
 Interinstitutional Agreements
 World Class Veterinary Expertise/Collaboration
 Shared IACUC members reduce regulatory delays
14
Certifications
AAALAC Certified
USDA licensed
OLAW assured
EU ETS123
15
Let us co-innovate with you!
CEO/CSO
 Rajan Bawa, PhD CEO/CSO
 (970) 493-0118
 rbawa@careresearchllc.com
National Sales Manager
 Brandy Phillips
 970-493-0118
 bphillips@careresearchllc.com

More Related Content

Similar to Care Research LLC, preclinical CRO

Enem Nostrum Presentation
Enem Nostrum PresentationEnem Nostrum Presentation
Enem Nostrum Presentation
Amit Khandagale
 
Sitec Presentation 140915
Sitec Presentation 140915Sitec Presentation 140915
Sitec Presentation 140915
Sitec Labs
 
Animal Testing: Rationale for conducting studies, CPCSEA Guidelines
Animal Testing: Rationale for conducting studies, CPCSEA Guidelines Animal Testing: Rationale for conducting studies, CPCSEA Guidelines
Animal Testing: Rationale for conducting studies, CPCSEA Guidelines
Parul Institute of Pharmacy
 

Similar to Care Research LLC, preclinical CRO (20)

Good Laboratory Practice(GLP) by Kashikant Yadav
 Good Laboratory Practice(GLP) by Kashikant Yadav Good Laboratory Practice(GLP) by Kashikant Yadav
Good Laboratory Practice(GLP) by Kashikant Yadav
 
MRA can successfully conduct your next research study; see how!
MRA can successfully conduct your next research study; see how!MRA can successfully conduct your next research study; see how!
MRA can successfully conduct your next research study; see how!
 
Enem Nostrum Presentation
Enem Nostrum PresentationEnem Nostrum Presentation
Enem Nostrum Presentation
 
Quality and Regulatory Affairs
Quality and Regulatory AffairsQuality and Regulatory Affairs
Quality and Regulatory Affairs
 
Good Laboratory Practices .pptx
Good Laboratory Practices .pptxGood Laboratory Practices .pptx
Good Laboratory Practices .pptx
 
CPCSEA .pptx
CPCSEA .pptxCPCSEA .pptx
CPCSEA .pptx
 
Sitec Presentation 140915
Sitec Presentation 140915Sitec Presentation 140915
Sitec Presentation 140915
 
The current regulatory framework
The current regulatory frameworkThe current regulatory framework
The current regulatory framework
 
Advantages of Animal Handling
Advantages of Animal Handling Advantages of Animal Handling
Advantages of Animal Handling
 
Animal Testing: Rationale for conducting studies, CPCSEA Guidelines
Animal Testing: Rationale for conducting studies, CPCSEA Guidelines Animal Testing: Rationale for conducting studies, CPCSEA Guidelines
Animal Testing: Rationale for conducting studies, CPCSEA Guidelines
 
Pharmacology Laboratory Animals.pptx
Pharmacology Laboratory Animals.pptxPharmacology Laboratory Animals.pptx
Pharmacology Laboratory Animals.pptx
 
Miami research associates oct. 2014
Miami research associates   oct. 2014Miami research associates   oct. 2014
Miami research associates oct. 2014
 
Repeated dose toxicity study
Repeated dose toxicity studyRepeated dose toxicity study
Repeated dose toxicity study
 
Overview of ICH Guidelines, CPCSEA
Overview of ICH Guidelines, CPCSEA Overview of ICH Guidelines, CPCSEA
Overview of ICH Guidelines, CPCSEA
 
Hcr Part2
Hcr Part2Hcr Part2
Hcr Part2
 
CPCSEA Guidelines ( Animal
CPCSEA Guidelines ( Animal CPCSEA Guidelines ( Animal
CPCSEA Guidelines ( Animal
 
GLP and Schedule 1
GLP and Schedule 1GLP and Schedule 1
GLP and Schedule 1
 
FCRL presentation
FCRL presentationFCRL presentation
FCRL presentation
 
GOOD LABORATORY PRACTICES
GOOD LABORATORY PRACTICES GOOD LABORATORY PRACTICES
GOOD LABORATORY PRACTICES
 
TOXICOPHARMACOLOGY.pdf
TOXICOPHARMACOLOGY.pdfTOXICOPHARMACOLOGY.pdf
TOXICOPHARMACOLOGY.pdf
 

Recently uploaded

POGONATUM : morphology, anatomy, reproduction etc.
POGONATUM : morphology, anatomy, reproduction etc.POGONATUM : morphology, anatomy, reproduction etc.
POGONATUM : morphology, anatomy, reproduction etc.
Cherry
 
CYTOGENETIC MAP................ ppt.pptx
CYTOGENETIC MAP................ ppt.pptxCYTOGENETIC MAP................ ppt.pptx
CYTOGENETIC MAP................ ppt.pptx
Cherry
 
PODOCARPUS...........................pptx
PODOCARPUS...........................pptxPODOCARPUS...........................pptx
PODOCARPUS...........................pptx
Cherry
 
Module for Grade 9 for Asynchronous/Distance learning
Module for Grade 9 for Asynchronous/Distance learningModule for Grade 9 for Asynchronous/Distance learning
Module for Grade 9 for Asynchronous/Distance learning
levieagacer
 
Pteris : features, anatomy, morphology and lifecycle
Pteris : features, anatomy, morphology and lifecyclePteris : features, anatomy, morphology and lifecycle
Pteris : features, anatomy, morphology and lifecycle
Cherry
 
Human genetics..........................pptx
Human genetics..........................pptxHuman genetics..........................pptx
Human genetics..........................pptx
Cherry
 

Recently uploaded (20)

FS P2 COMBO MSTA LAST PUSH past exam papers.
FS P2 COMBO MSTA LAST PUSH past exam papers.FS P2 COMBO MSTA LAST PUSH past exam papers.
FS P2 COMBO MSTA LAST PUSH past exam papers.
 
GBSN - Biochemistry (Unit 3) Metabolism
GBSN - Biochemistry (Unit 3) MetabolismGBSN - Biochemistry (Unit 3) Metabolism
GBSN - Biochemistry (Unit 3) Metabolism
 
Concept of gene and Complementation test.pdf
Concept of gene and Complementation test.pdfConcept of gene and Complementation test.pdf
Concept of gene and Complementation test.pdf
 
Daily Lesson Log in Science 9 Fourth Quarter Physics
Daily Lesson Log in Science 9 Fourth Quarter PhysicsDaily Lesson Log in Science 9 Fourth Quarter Physics
Daily Lesson Log in Science 9 Fourth Quarter Physics
 
X-rays from a Central “Exhaust Vent” of the Galactic Center Chimney
X-rays from a Central “Exhaust Vent” of the Galactic Center ChimneyX-rays from a Central “Exhaust Vent” of the Galactic Center Chimney
X-rays from a Central “Exhaust Vent” of the Galactic Center Chimney
 
GBSN - Microbiology (Unit 4) Concept of Asepsis
GBSN - Microbiology (Unit 4) Concept of AsepsisGBSN - Microbiology (Unit 4) Concept of Asepsis
GBSN - Microbiology (Unit 4) Concept of Asepsis
 
Genome Projects : Human, Rice,Wheat,E coli and Arabidopsis.
Genome Projects : Human, Rice,Wheat,E coli and Arabidopsis.Genome Projects : Human, Rice,Wheat,E coli and Arabidopsis.
Genome Projects : Human, Rice,Wheat,E coli and Arabidopsis.
 
POGONATUM : morphology, anatomy, reproduction etc.
POGONATUM : morphology, anatomy, reproduction etc.POGONATUM : morphology, anatomy, reproduction etc.
POGONATUM : morphology, anatomy, reproduction etc.
 
CYTOGENETIC MAP................ ppt.pptx
CYTOGENETIC MAP................ ppt.pptxCYTOGENETIC MAP................ ppt.pptx
CYTOGENETIC MAP................ ppt.pptx
 
Energy is the beat of life irrespective of the domains. ATP- the energy curre...
Energy is the beat of life irrespective of the domains. ATP- the energy curre...Energy is the beat of life irrespective of the domains. ATP- the energy curre...
Energy is the beat of life irrespective of the domains. ATP- the energy curre...
 
PODOCARPUS...........................pptx
PODOCARPUS...........................pptxPODOCARPUS...........................pptx
PODOCARPUS...........................pptx
 
TransientOffsetin14CAftertheCarringtonEventRecordedbyPolarTreeRings
TransientOffsetin14CAftertheCarringtonEventRecordedbyPolarTreeRingsTransientOffsetin14CAftertheCarringtonEventRecordedbyPolarTreeRings
TransientOffsetin14CAftertheCarringtonEventRecordedbyPolarTreeRings
 
GBSN - Microbiology (Unit 3)Defense Mechanism of the body
GBSN - Microbiology (Unit 3)Defense Mechanism of the body GBSN - Microbiology (Unit 3)Defense Mechanism of the body
GBSN - Microbiology (Unit 3)Defense Mechanism of the body
 
Module for Grade 9 for Asynchronous/Distance learning
Module for Grade 9 for Asynchronous/Distance learningModule for Grade 9 for Asynchronous/Distance learning
Module for Grade 9 for Asynchronous/Distance learning
 
Pteris : features, anatomy, morphology and lifecycle
Pteris : features, anatomy, morphology and lifecyclePteris : features, anatomy, morphology and lifecycle
Pteris : features, anatomy, morphology and lifecycle
 
Human genetics..........................pptx
Human genetics..........................pptxHuman genetics..........................pptx
Human genetics..........................pptx
 
GBSN - Biochemistry (Unit 2) Basic concept of organic chemistry
GBSN - Biochemistry (Unit 2) Basic concept of organic chemistry GBSN - Biochemistry (Unit 2) Basic concept of organic chemistry
GBSN - Biochemistry (Unit 2) Basic concept of organic chemistry
 
Cyanide resistant respiration pathway.pptx
Cyanide resistant respiration pathway.pptxCyanide resistant respiration pathway.pptx
Cyanide resistant respiration pathway.pptx
 
CURRENT SCENARIO OF POULTRY PRODUCTION IN INDIA
CURRENT SCENARIO OF POULTRY PRODUCTION IN INDIACURRENT SCENARIO OF POULTRY PRODUCTION IN INDIA
CURRENT SCENARIO OF POULTRY PRODUCTION IN INDIA
 
Cot curve, melting temperature, unique and repetitive DNA
Cot curve, melting temperature, unique and repetitive DNACot curve, melting temperature, unique and repetitive DNA
Cot curve, melting temperature, unique and repetitive DNA
 

Care Research LLC, preclinical CRO

  • 1. Your Partner for Co-Innovation 1
  • 2. 2
  • 3. We have the experience you need! 3 Unparalleled Regulatory Guidance >> to ensure unhindered FDA/EPA/OECD acceptance Specialized Expertise & Facilities >> to conduct studies effectively Small & Large Animal Species>> to customize studies & meet unique needs Depth of Experience >> to conduct studies efficiently and humanely Responsive Updates & Feedback >> to provide guidance for mid-course adjustments We treat your project like it’s our own
  • 4. Comprehensive guidance from start to finish 4 Experienced study directors involved throughout Expert protocol development process Accelerated IACUC Approval Able to meet aggressive timelines Large library of standard studies Standardized reporting methods Continuous study progress updates Experienced Regulatory Review
  • 6. Well-rounded experience we can leverage  Over 150 years of combined experience conducting toxicology studies  Distinguished IACUC Committee involvement (to deliberate and approve projects on ongoing basis)  Track Record of Receiving Approval for Several IND & NDA Enabling Studies 6
  • 7. Wide range of capabilities ■ PK/MTD to DART studies ■ Custom Medical Device preclinical studies ■ 510K to IND/IDE submission regulatory guidance ■ IND/NDA Enabling studies ■ Multi-functional capabilities spanning in vivo models, surgeries, clinical and histopathology 7
  • 8. Capabilities (cont.)  Behavioral Evaluation: FOB Analyses & Maze Testing  Modern, fully-equipped veterinary surgical suite  Imaging Equipment CT Scanner, C-ARM & Dexascan  24/7 Video Monitoring 8
  • 9. OUR ANIMALS Diverse Animal Species From Small to Large 9
  • 10. Outdoor Pastures - Large Farm Animals, Equine to Swine Indoor Facilities – Rodents to Dogs 10
  • 11. Species of focus (GLP & non-GLP)  Acute to chronic toxicity  Pharmacokinetic / Toxicokinetic models  Reproductive/ developmental toxicology  Special models (arthritis, respiratory, in-vivo biocompatibility)  Ocular Implants  Dermal sensitivity  Acute/chronic toxicity  Pharmacokinetic / Toxicokinetic models  Surgical device development  Feed/nutrition  Wound Healing 11  Acute to chronic toxicity  Pharmacokinetic / Toxicokinetic models  Surgical models  Gait analysis  Efficacy  MTD SMALL LARGE S t u d y T y p e s Mice, rats, ferrets, rabbits, hamsters, guinea pigs, etc. Dogs, cats, horses, etc. Porcine, Equine, Bovine, Ovine, Poultry, etc.
  • 12. Case studies -- Devices ■ Pulmonary Devices to Treat Emphysema ■ Tissue Adhesives & Wound Healing ■ Cardio-Vascular Stents ■ Surgical Devices Development ■ Ocular Implants ■ Muscular Implants ■ Ablation Devices (Liver, Lung, Bladder)
  • 13. Case studies - Drugs ■ Neurotropic Drug – DART/NDA Enabling, allowed Phase-3 Clinical Trials ■ Ophthalmic Biologic- Resulted in Approval of Phase-2 Clinical Trials with Minimal Testing ■ Nasal Delivery ■ Ocular Drug Delivery ■ IBD Models ■ 5 Different Drugs for Separate Clients Taken off Clinical Hold 13
  • 14. CSU Department of Lab Animal Resources  CARE & CSU LAR Relationship  Interinstitutional Agreements  World Class Veterinary Expertise/Collaboration  Shared IACUC members reduce regulatory delays 14
  • 16. Let us co-innovate with you! CEO/CSO  Rajan Bawa, PhD CEO/CSO  (970) 493-0118  rbawa@careresearchllc.com National Sales Manager  Brandy Phillips  970-493-0118  bphillips@careresearchllc.com