We support clinic trials from Phase I to Phase IV, ISS/ISE and post-submission activities, and medical device applications

Statistical services

* Provide support for DSMB/DMC and Clinical Events

* Design and review protocols, study reports, ISS/ISE, and other submission documents
* Prepare and review the Statistical Analysis Plan (SAP)

* Clinical Study Protocol, eCRF, Data Management Plan, UAT Specs, and clinical study report review
* Exploratory analyses and publications

* Statistical consulting

SAS programming services

* Table/Listing/Graphs (TLGs) and Table Listing/Figures(TLFs) generation and validation
* Data mapping and CDISC implementation(SDTM and ADaM, annotated CRF, etc) for legacy studies

* Derived data set production and validation
* DSMB data center and multiple EDC platform data programming support

* Submission-ready data sets and program validation
* Staff placement and on-site staffing support

Medical writing services

* CH guidelines compliance

* Clinical study protocol

* Clinical study report

* Integrated summary

* NDA submission

* Publication and presentation