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
