Study Conduct

PANTHER CTMP™ CONFIGURATION

  • CRF Design & Database Setup
  • IWRS and CTMS Setup
  • Randomization Schedule
  • EDC Start Up, Training and UAT Support
  • Fast Protocol Amendment Support

BIOSTATISTICS AND PROGRAMMING

  • Statistical Analysis Plan (SAP)
  • SDTM Datasets
  • ADaM Dataset Creation
  • TLF Creation
  • ISS/ISE, Interim Analysis, Submission
  • Stats CSR Reporting

DATA MANAGEMENT

  • Data Management Plan (DMP)
  • Query Management
  • Randomization and Trial Supply Management
  • External data loading and reconciliation
  • Adverse Event Reporting/Reconciliation
  • MedDRA and WHO-Drug Coding
  • Database Lock

THERAPEUTIC AREAS

  • Oncology
  • Anti-inflammatory/Pain
  • Infectious Disease
  • Nephrology
  • Neurology/CNS
  • Cardiovascular
  • Gastroenterology
  • Ophthalmology
  • Allergy
  • Vaccine
  • PK/PD
  • Diabetes and metabolic disease
  • Dermatology