Our Services

Comprehensive clinical research solutions tailored to accelerate your drug development journey from concept to market.

End-to-End CRO Solutions

Expert clinical research services across the entire drug development lifecycle

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Clinical Trial Management

End-to-end management from protocol development through trial completion.

  • โœ“ Phase I-IV trial management
  • โœ“ Global site network
  • โœ“ Regulatory compliance
  • โœ“ Full operational oversight
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Regulatory Affairs

Strategic regulatory support and submission preparation for global agencies.

  • โœ“ IND, NDA, and BLA prep
  • โœ“ FDA, EMA expertise
  • โœ“ Regulatory strategy
  • โœ“ Post-approval support
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Clinical Data Management

Secure, CDISC-compliant data management ensuring regulatory readiness.

  • โœ“ EDC implementation
  • โœ“ CDISC compliance
  • โœ“ Real-time validation
  • โœ“ Database lock & reporting
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Biostatistics & Analysis

Statistical expertise supporting trial design, analysis, and regulatory reporting.

  • โœ“ SAP development
  • โœ“ Statistical modeling
  • โœ“ Graphical reporting
  • โœ“ Regulatory-ready analyses
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Clinical Operations

Operational support including site management, QA, and compliance oversight.

  • โœ“ Site initiation & training
  • โœ“ Quality assurance
  • โœ“ Protocol compliance
  • โœ“ Budget & timeline mgmt
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Pharmacovigilance

Comprehensive safety monitoring ensuring patient safety and regulatory compliance.

  • โœ“ Safety event tracking
  • โœ“ Regulatory reporting
  • โœ“ DSMB support
  • โœ“ Post-approval surveillance

Our Process

Streamlined approach to ensure efficient and compliant clinical research

1

Consultation

Initial assessment and strategy development

2

Planning

Detailed protocol and regulatory planning

3

Execution

Seamless implementation and monitoring

4

Delivery

Final reporting and regulatory submission

Quality Assurance & Compliance

Our rigorous quality management system ensures all services meet the highest standards of compliance and scientific integrity.

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GCP, GLP, and GMP compliance
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Regular quality audits and training
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Risk-based quality management

Clinical Research Support for Wound Care Programs

Kerevna supports sponsors developing next-generation wound care therapies through specialized expertise and dedicated support

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Feasibility Assessments

Comprehensive feasibility assessments for wound care trials including site evaluation, patient population analysis, and timeline projections.

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Specialized Site Identification

Identification of specialized wound care clinics and investigators with expertise in chronic wound management and clinical research.

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Patient Recruitment Strategies

Targeted patient recruitment strategies for chronic wound populations including diabetic ulcers, pressure injuries, and venous leg ulcers.

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Biospecimen Procurement

Expert biospecimen procurement including tissue samples, wound swabs, plasma/serum collection, and proper handling for laboratory analysis.

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Site Activation & Coordination

Efficient site activation and study coordination including investigator training, regulatory documentation, and ongoing site management.

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Real-World Data Collection

Systematic real-world data collection to support clinical outcomes, wound healing metrics, and post-market surveillance requirements.

Specialized Wound Care Expertise

Our team brings deep understanding of wound care research challenges, from complex patient populations to specialized endpoint assessments and regulatory requirements for advanced wound therapies.

Discuss Your Wound Care Study

Ready to Discuss Your Project?

Let's explore how our comprehensive CRO services can accelerate your clinical research objectives.

Contact Our Experts