Sample size calculation and justification
Protocol development and review
Randomization schedule development
CRF and SAR review
SAP preparation
TFLs shells development
Statistical analysis and report preparation
SDTM and ADaM
Reviewers guidelines
(SDRG and ADRG) development
Sample size SAS codes development
Randomization schedule SAS codes development
Implementation of data management plans and approved SAP
CRF annotation
Development of specifications for analysis datasets
Preparation and finalization of SAS programs for SDTM/ADaM datasets and TFLs
Datasets validation according to CDISC
Define.xml development
Clinical trial design
Endpoints justification
Protocol development and review
Supporting Clinical trial from study planning till CSR registration
Clinical Study Report (CSR) development
Articles and publications
Database planning and development
Database administration
Preparing the database for interim/ final analysis
Medical/ pharmaceutical coding
Database lock
Serious Adverse Events (SAE) Reconciliation
Data archiving
Sample Consulting
Ability to find a professional for your requirements (therapeutic area/study phase/etc.):
