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About Target Health

Target Health, LLC

a full-service CRO and Clinical Trials Software company

Target Health LLC. is a privately held, New York City based company with staff dedicated to all aspects of Regulatory Affairs, Clinical Research, Biostatistics, Data Management, Internet-Based Clinical Trials (EDC, electronic data capture), Software Development, Strategic Planning and Drug and Device Development. Target Health LLC. also has a group of specialized advisors in the areas of Toxicology, Analytical Methods Validation, Product and Process Development, Quality Assurance and Manufacturing.

Services Provided

  • Regulatory Affairs
  • Clinical Research Management
  • Medical Writing
  • Biostatistics
  • Data Management
  • Electronic Data Capture (Target e*CRF)
  • Quality Assurance
  • Strategic Planning
  • Drug Development
  • Device Development
  • Toxicology
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Innovate and Collaborate

Full Service CRO

  • Regulatory Affairs
  • Strategic Planning
  • Clinical Research
  • Data Management
  • Biostatistics
  • Medical Writing

Clinical Trial Software

  • Paperless Clinical Trials
  • Study Builder
  • eInformed Consent
  • IRT (Randomization & IMP)
  • Safety DB (SAE)
  • External Integration

Regulatory Affair Services

  • Pre IND/IDE documents
  • IND and IND amendments
  • IDE
  • 510(K)
  • NDA
  • PMA and more

Our Global Reach

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Quality of Service Proven by Experiences

Early Stage Experience

  • Gaucher disease: Pre-clinical to NDA
  • Head Lice: Pre-clinical to NDA
  • Ulcerative colitis: Pre-clinical to Phase 2
  • Oncology: Multiple phase 1 and phase 2 (ongoing)
  • Enzyme Replacement: Preclinical to NDA (ongoing)
  • Topical NSAID: Preclinical to Phase 2 (ongoing)

Paperless Clinical Program

  • Hypogonadism
  • Hair Loss Prevention in Breast Cancer Chemotherapy
  • Suicide Prevention
  • ADHD and more

Drug Experience and Approvals (Partial)

  • NDA - Nocturia - EDC; Regulatory Consulting; DM; Statistics; NDA submission
  • NDA - Gaucher Disease - EDC; Regulatory Consulting, Toxicology, Monitoring; DM; Statistics; Medical Writing; NDA submission
  • BLA - Inflammation - EDC
  • NDA/MAA - Hereditary Angioedema - EDC
  • NDA/MAA Emergency Contraception - EDC; Regulatory Affairs, Monitoring; DM; Statistics; Medical Writing

Oncology

Metabolic

Infectious Disease

CNS

Rare/Orphan

Women's Health

Immunology