Data Management

Skills, Experience and Quality Data You Need – Fast! 

  • ‍Our skilled people are accustomed to working with companies large and small, providing personalized service and success
  • ‍Experienced data management team stays with you from start-up through study closure
  • Our Quality-Driven approach provides you the ability to review your data and documents anytime, enabled by systems that have been reviewed and audited by FDA
Operational Excellence
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Study Start-up

eCRF Design

User Acceptance Testing

Data Validation Plan

  • Online (Real Time, Batch): Integrated with EDC
  • Offline (SAS)

EDC User Training

Data Management Plan

External Data Integration

  • Data Transfer Specification
  • Central Lab
  • ECG Core Lab
  • Pharmacokinetic/Pharmacodynamic Data
  • IxRS Data
  • CTMS Data
  • ePRO
  • Devices

Study Conduct

Data Review/Cleaning

  • Data Tables, Listings and Figures

Patient Profile

DSMB Support

External Data Reconciliation

SAE Reconciliations

Medical Coding

  • MedDRA
  • WHO Drug

Data Standard

  • CDISC SDTM Mapping Annotation (aCRF)
  • CDISC SDTM Mapping Programming
  • CDISC SDTM Define.xml
  • CDISC SDTM Reviewer’s Guide
  • Sponsor Specific Standards

Study Closeout

Database Lock

  • Multiple DB Lock Support
  • - Adaptive Study Designs
  • - Interim Analyses
  • - Final Lock
  • Clean File Meeting
  • - Data Lock Documentation

Regulatory Submission Support

Technology
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SAS

Target Health Clinical Trials Software Suite

  • Target e*CRF® (EDC)
  • Target e*CTR® (eSource/Direct Data Entry)
  • Target e*ICF® (Electronic Informed Consent)
  • Target IWRS (Randomization)
  • Target e*IMP (IMP Management)
  • Target ePRO (Electronic Patient Reported Outcome)
  • Target e*Monitoring® (Monitoring Reports)
  • Target e*Pharmacovigilance® (SAE Reporting)
  • Target Encoder® (Medical Coding)
  • Target Document® (Document Management)

Pinnacle 21 (SDTM Validation)

JReview (Ad-hoc Reporting)

Theraputic Experience

  • 3rd Degree Burns
  • Acute Kidney Injury
  • ADHD
  • Alopecia
  • Alzheimer’s Disease
  • AMD
  • Breast cancer
  • Bullous Pemphigoid
  • Constipation
  • Cystic fibrosis
  • Diabetes
  • Diabetic Foot Ulcer
  • DME
  • Emergency Contraception
  • Fabry disease
  • Gaucher Disease
  • Growth Hormone Deficiency
  • Head lice
  • Hemophilia
  • Hereditary Angioedema
  • Infertility
  • Inflammation
  • Irritable Bowel Syndrome
  • Leukemia
  • Lymphoma
  • Menopause therapy
  • Migraines
  • Nocturia
  • Obesity
  • Oncology
  • Pancreatic Insufficiency
  • Prostate cancer
  • ‍Pediatric Autism
  • Periodontal Disease
  • Schizophrenia
  • Ulcerative Colitis

Resources

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Contact Target Health

Reach out today and let us know how we can help you!
Phone: 212-681-2100
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