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Subject
Study Details
Services
Drafting protocol
Sample Size calculation and Statistical Analysis
Sites Feasibility and Sites Selection
Selection of laboratories
Data management Plan Design
Randomization List generation
Study email and website (optional)
Monitoring Plan Design
Validation Plan Design
Kick Off Meeting
TMF preparation and ISF preparation
Approval from Competent Authority (CA) (for pre-market studies)
Contract Negotiation
Good Clinical Practice (GCP) Training and Curriculum Vitae (CV)
IP Management
Data Management
Remote and On site Monitoring
IP Accountability
Newsletter
DSMB and CEC Organization
Investigator meetings
Clinical Study Report
Database lock
Archiving
Preparation of Synopsis
Budgeting and Patients Fee calculations
Contract Reseach Organization (CRO) selection
Stipulation of Insurance
eCRF design
Data Safety Monitoring Board (DSMB) or Clinical Events Committee
STATISTICAL PLAN Design
Quality Plan Design
Risk management analysis
Registration of the study on clinicaltrials.gov
Preparation of Documents and Dossier to submit to EC/CA and applying for Research Ethics Committee Opinion
Notification to Competent Authority (CA) (for post-market studies)
Investigators’ meetings
SIV preparation
Notification of first enrolment to the EC
Data entry
Amendments
GAP Analysis
Preliminary or Interim Report
Meetings with CRO
COV
Statistical analysis
Data cleaning
Study Type
– Select –
Interventional
Observational
Sponsor
– Select –
Profit
Non-Profit
Number of Nations Involved
Number of Centers Involved
Number of Patients Involved
Expected Start Date
Enrollment Period Months
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