CRO & Pharmaceutical Laboratory Services

Overview

CARE9’s Contract Research Organization (CRO) and Pharmaceutical Laboratory Services provide comprehensive support for clinical drug development, regulatory submissions, and pharmaceutical research. Our integrated services combine clinical trial management, bioanalytical testing, pharmaceutical analysis, and regulatory consulting to accelerate the path from drug discovery to market approval.

CRO Services Portfolio

Clinical Trial Services

Phase 1 & Phase 2 Clinical Trials

First-in-human (FIH) drug studies
Healthy volunteer recruitment and screening
Pharmacokinetics and pharmacodynamics studies
Dose escalation and tolerability assessment
Early efficacy evaluation in patient populations
Specialized facility with isolation units
24-hour patient monitoring capabilities
Experienced clinical pharmacology team

Phase 3 & Phase 4 Clinical Trials

Large-scale efficacy and safety studies
Multi-center trial coordination
Chronic disease patient populations
Long-term safety monitoring
Post-marketing surveillance studies
Patient recruitment across networks
Investigator site management
Protocol amendments and regulatory interactions

Pediatric & Special Population Trials

Pediatric formulation studies
Geriatric patient population trials
Renal and hepatic impairment studies
Drug-drug interaction studies
Pregnancy and lactation studies
Special populations (HIV, diabetes, cancer)
Age-appropriate informed consent processes
Specialized safety monitoring protocols

Oncology & Specialty Clinical Trials

Cancer drug efficacy and safety studies
Immunotherapy and checkpoint inhibitor trials
Combination therapy studies
Real-world evidence generation
Quality of life assessments
Biomarker-driven study designs
Oncology patient networks
Specialized infrastructure for cancer patients

Trial Operations & Management

Site Activation & Management

Investigator site identification and recruitment
Site initiation training and startup
Protocol training and GCP (Good Clinical Practice) education
Site compliance monitoring
Query resolution and data clarification
Recruitment support and patient enrollment
Site closeout and archival
Performance management and metrics

Patient Recruitment & Retention

Patient identification from hospital networks
Informed consent process management
Patient enrollment and randomization
Retention and follow-up programs
Adverse event documentation and reporting
Patient communication and support
Loss-to-follow-up minimization
Patient satisfaction and feedback programs

Data Management & Statistics

Case report form (CRF) design and development
Electronic data capture (EDC) system implementation
Data validation and query management
Database lock and medical coding
Statistical analysis planning
Biostatistical analysis and reporting
Safety and efficacy analysis
Interim analysis support

Regulatory Support

IND (Investigational New Drug) application preparation
Study protocol development
Informed consent form (ICF) development
Regulatory correspondence and submissions
Ethics committee and IRB interactions
Safety reporting and updates
Study status reports
Regulatory liaison services

Pharmacovigilance Services

Safety Monitoring

Adverse event collection and reporting
Serious adverse event (SAE) management
Expedited reporting (24-hour SAE reporting)
Safety committee oversight
Risk minimization programs
Signal detection and evaluation
Pharmacovigilance plans (PVP)
Risk management strategies

Post-Marketing Surveillance

Phase 4 post-authorization safety studies
Epidemiological studies
Comparative effectiveness research
Real-world evidence generation
Adverse event registries
Periodic safety updates (PSUR)
Risk benefit assessments
Cumulative safety analysis

Pharmaceutical Laboratory Services

Bioanalytical Testing

Liquid Chromatography-Mass Spectrometry (LC-MS/MS)

Small molecule drug quantification
Biomarker analysis
Metabolite identification and characterization
Protein biomarker analysis
Drug metabolite stability assessment
Multi-analyte method development
Method validation (USFDA guidance compliant)
Sample analysis with 24-hour turnaround

Immunoassay Services

ELISA (Enzyme-Linked Immunosorbent Assay)
Radioimmunoassay (RIA)
Chemiluminescence immunoassay (CLIA)
Multiplex immunoassays
Biomarker panel development
High-sensitivity assays
Fully validated methods
GCP-compliant testing

Sample Analysis

Blood, plasma, serum analysis
Urine and CSF testing
Tissue sample analysis
Microbiological specimen testing
Special matrix analysis
Stability testing protocols
Long-term sample archival
Chain of custody documentation

Analytical & Chemistry Services

Method Development & Validation

Stability-indicating methods
USFDA compliant method validation
ICH guidelines adherence
Analytical procedures for CMC (Chemistry, Manufacturing, Controls)
Assay method development
Impurity methods
Related substances testing
Analytical gap closure for CMC

Pharmaceutical Analysis

Content uniformity testing
Dissolution testing (USP apparatus I-IV)
Hardness and friability testing
Moisture analysis (Karl Fischer titration)
Particulate analysis
Moisture permeation studies
Polymer characterization
Excipient compatibility studies

Stability Testing

ICH long-term stability studies (25°C/60% RH)
Intermediate stability (30°C/75% RH)
Accelerated stability testing (40°C/75% RH)
Photostability testing
Thermal stability assessment
Kinetic stability predictions
Shelf-life determination
Regulatory guidance-compliant protocols

Environmental Stability Chambers

Programmable temperature and humidity control
Real-time monitoring and data logging
Multiple chamber capacity
Stability studies for 5+ years
Regulated records and documentation
ISO 17025 accredited testing

Microbiology & Sterility Testing

Microbiological Testing

Sterility testing per pharmacopeial standards
Bacterial endotoxin (pyrogen) testing
Antimicrobial effectiveness (preservative challenge)
Bioburden testing
Environmental monitoring
Media fill validation
Rapid microbiological methods
USP/Ph. Eur./BP compliant testing

Quality Control Microbiology

Finished product sterility assurance
Raw material microbial testing
In-process environmental monitoring
Personnel monitoring programs
Equipment validation
Compressed air quality testing
Water system monitoring
Aseptic process simulation

Nonclinical Safety Testing (Toxicology)

In Vitro Toxicology

Cell culture cytotoxicity studies
Genotoxicity assessment (Ames test, micronucleus)
Phototoxicity testing
Irritation and corrosivity assessment
Skin sensitization assays
Hemolysis studies
Endotoxin and pyrogen testing
Biocompatibility testing

In Vivo Toxicology

Single and repeat-dose toxicity studies
Genotoxicity studies (in vivo)
Carcinogenicity and mutagenicity assessment
Reproductive and developmental toxicity
Pharmacokinetic studies (animal models)
ADME (Absorption, Distribution, Metabolism, Excretion) studies
Mechanistic toxicology studies
GLP (Good Laboratory Practice) compliance

CRO Infrastructure & Facilities

Clinical Trial Facilities

Research Centers

Dedicated inpatient ward facilities
Isolation units for infectious disease studies
Intensive monitoring capabilities
24-hour nursing and medical staff
Emergency medical services
Clinical laboratory facilities
Pharmacy and medication storage
Comfortable patient accommodation

Ambulatory Centers

Outpatient clinic facilities
Appointment scheduling systems
Patient waiting areas
Treatment administration rooms
Blood draw stations
Patient education resources
Staff training areas
Administrative offices

Laboratory Facilities

Bioanalytical Laboratory

LC-MS/MS instruments and backup systems
HPLC instruments for sample analysis
Immunoassay analyzers
Sample preparation areas
Refrigerated sample storage (-20°C to -80°C)
ISO 17025 accreditation
USFDA 21 CFR Part 11 compliance
GCP and GLP adherence

Chemistry & Stability Laboratory

Multiple analytical instruments
Temperature and humidity-controlled chambers
Dissolution apparatus (USP)
HPLC and GC systems
Gravimetric and volumetric equipment
Specialized testing capability
Detailed documentation and archival
Regulatory-compliant operations

Microbiology Laboratory

Laminar flow hoods and biosafety cabinets
Autoclave and sterilization equipment
Incubators and culture systems
Particle counting equipment
Air sampling equipment
Personnel and environmental monitoring
Rapid detection systems
Full GMP compliance

Service Delivery Models

Full-Service CRO Partnership

End-to-end trial management
From protocol design through reporting
Multi-country trial coordination
Regulatory submission support
Fixed-price or milestone-based engagement
Dedicated project teams

Site Management Organization (SMO)

Patient recruitment and site activation
Investigator coordination
Protocol adherence monitoring
Data collection support
Patient retention programs
Quality assurance oversight
Regulatory interactions

Specialty Service Model

Bioanalytical testing services
Pharmacovigilance support
Statistical analysis
Regulatory consulting
Medical writing services
Specialized population studies

Blinded Services Model

Independent safety monitoring
Data validation and audit
Statistical analysis
Regulatory interaction
Quality assurance activities
Objective oversight

Performance Metrics

95%+ Study protocol compliance rate
98%+ Accurate data entry rate
<1% Protocol deviation rate
100% Regulatory submission accuracy
<24 hours SAE reporting time
99.5% Patient enrollment target achievement
<5% Patient drop-out rate
4-6 months Average Phase 1 study duration
18-24 months Average Phase 3 study duration
100+ Active clinical trials across portfolio

Clinical Trial Capacity

Enrollment Capability

100-200 Phase 1 subjects annually
500-1000 Phase 2/3 subjects annually
20+ research sites In network
500+ patient database For recruitment
24/7 enrollment support Across regions
Multi-country recruitment Capabilities

Bioanalytical Testing Capacity

100+ assays In validated portfolio
5000+ samples Processing monthly
<48 hour Turnaround for most analyses
99%+ Quality pass rate
Zero Non-compliant data submissions

Target Markets

Therapeutic Focus Areas

Oncology and cancer research
Cardiovascular and metabolic diseases
Infectious diseases and vaccines
Immunology and autoimmune disorders
Neurology and psychiatry
Gastroenterology
Dermatology
Rare and orphan diseases

Geographic Expansion

India (primary CRO hub)
Sub-Saharan Africa expansion
Southeast Asia (Vietnam, Philippines)
Latin America (Brazil, Mexico)
Eastern Europe opportunities
Middle East and North Africa (MENA)

Impact Projections

CRO Growth Potential

₹500-750 Cr Annual CRO revenue by 2028
100+ active trials Concurrent management
5000+ patient enrollment Annually
500+ studies completed Cumulatively
50+ countries Study site presence
1000+ employees Across CRO operations

Economic Impact

₹1000-1500 Cr Patient service value
15-20% ROI For pharmaceutical partners
2000+ jobs Created (clinical, laboratory, support)
₹300-400 Cr Regulatory approval acceleration value
Cost savings Of 20-30% vs Western CROs

Competitive Advantages

Clinical Excellence

Experienced clinical trial teams
Network of qualified investigators
Patient recruitment expertise
Regulatory knowledge and compliance
Quality monitoring and assurance
Ethical conduct standards

Laboratory Capabilities

State-of-the-art instrumentation
Multiple validated analytical methods
GCP, GLP, and GMP compliance
International accreditations
Rapid turnaround times
Specialized testing expertise

Emerging Market Focus

Deep understanding of local regulations
Patient population expertise
Cost efficiency vs Western CROs
Local regulatory relationships
Healthcare system integration
Sustainability focus

Technology & Innovation

Electronic data capture (EDC) systems
Patient tracking and follow-up
Data analytics and reporting
CTMS (Clinical Trial Management Systems)
Mobile health integration
Predictive analytics

Regulatory Compliance

GCP (Good Clinical Practice): ICH-E6 compliance
GLP (Good Laboratory Practice): USFDA standards
GMP (Good Manufacturing Practice): Pharmaceutical manufacturing
USFDA 21 CFR Part 11: Electronic records compliance
ISO 17025: Laboratory accreditation
ISO 9001: Quality management systems
Bioethics: Institutional review board oversight
Data Protection: Patient confidentiality and privacy

Future Roadmap

Expanded Facilities: Additional CRO centers in key markets
Precision Medicine: Biomarker-driven trial designs
Real-World Evidence: Registry-based trial integration
Digital Health: Remote patient monitoring and e-consent
AI & Analytics: Predictive analytics for trial design
Specialized Populations: Enhanced pediatric and geriatric capabilities
Integrated Services: Full end-to-end pharmaceutical development
Sustainability Focus: Green laboratory and trial practices