Important Regulatory Pathways for Accelerated Approval
– Takes about 6 minutes to read this topic – The U.S. FDA has implemented various programs that help to deliver safe and effective therapies
- ProductsCLINICAL DATA MANAGEMENT
EDC
One size does not fit all
Safety Notification
RTSM
Deliver powerful randomization methods
CODER
Fast and accurate clinical coding
Drug and Device Logistics
Mitigate risk and create closer connections
CLINICAL OPERATIONS
eTMF
Essential document collection
CTMS
Accelerate your trial and ensure data integrity
PATIENT CENTRICITY
eCONSENT
Meet patients where they are
eCOA
Faster, cleaner and more reliable data
Patient Poll
Quick insights from patients
CLINICAL DATA MANAGEMENTPATIENT CENTRICITYCLINICAL OPERATIONS - ServicesCLINICAL TRIAL SERVICES
eCRF Setup
Capture better data, faster
eTMF Setup
Get up and running in no time
PV Management
Identify and handle your safety management needs
Data Management
Make more informed business decisions
Managed Service Model for MDR
Migration, Consulting and Customization for your MDR
Submission and Data Mapping
Move and consolidate data
eTechnology Strategy
Integrate and capitalize on critical technologies
Protocol Development
Turning your research question into a study
DATA SCIENCE SERVICES
Observational Studies
Digital, cost effective and time efficient
Primary Market Research
Direct to patient, unique, and quality data
IRB and EC Management
End to end regulatory management
PV and GDPR Compliance
Safety, consent and data protection
Scientific Communications
Results dissemination
Digital Communications
Increase patient awareness
Data Linkage
Generate, combine and analyze data
CLINICAL TRIAL SERVICESDATA SCIENCE SERVICES
