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MacroStat, Inc.
Delaware Technology Park
One Innovation Way
Suite 302
Newark, DE 19711, USA
Phone: (302) 438-2889
Fax: (302) 239-7442
498 Guoshoujing Road
Suite 11301-11304
Shanghai, 201203, China
Phone: (86) 21-50276030
Fax: (86) 21-50807377
www.macrostat.com.cn
info@macrostat.com
Delaware Technology Park
One Innovation Way
Suite 302
Newark, DE 19711, USA
Phone: (302) 438-2889
Fax: (302) 239-7442
498 Guoshoujing Road
Suite 11301-11304
Shanghai, 201203, China
Phone: (86) 21-50276030
Fax: (86) 21-50807377
www.macrostat.com.cn
info@macrostat.com
Services We Provide
Services
- Propose Clinical Trial Strategies
- Develop Clinical Trial Protocols
- Design Case Report Forms (CRF)
- Design and Setup Database
- Conduct Double Data Entry
- Perform Data Management
- Develop Statistical Analysis Plans (SAP)
- Create CDISC SDTM/ADaM and Analysis Datasets
- Develop SAS Programs
- Conduct Sensitivity and Exploratory Analyses
- Support Data and Safety Monitoring Board (DSMB)
- Write Clinical and Statistical Reports
- Prepare Global Submission of New Drug Applications (IND/NDA)
- Develop Clinical Trial Protocols
- Design Case Report Forms (CRF)
- Design and Setup Database
- Conduct Double Data Entry
- Perform Data Management
- Develop Statistical Analysis Plans (SAP)
- Create CDISC SDTM/ADaM and Analysis Datasets
- Develop SAS Programs
- Conduct Sensitivity and Exploratory Analyses
- Support Data and Safety Monitoring Board (DSMB)
- Write Clinical and Statistical Reports
- Prepare Global Submission of New Drug Applications (IND/NDA)
MacroStat, Inc.
We have applied an efficient process to manage multiple tasks
and QA prior to database lock. Statistical analyses are completed
within 1 day of database lock. Draft study report is written within 10
days of database lock.
and QA prior to database lock. Statistical analyses are completed
within 1 day of database lock. Draft study report is written within 10
days of database lock.
We have successfully passed all of the audits conducted by our
clients for company organization, SOP administration, security of
facilities, information system infrastructure, and validation of
computer systems. We have developed a White Paper in meeting
FDA 21 CFR Part 11 requirements.
clients for company organization, SOP administration, security of
facilities, information system infrastructure, and validation of
computer systems. We have developed a White Paper in meeting
FDA 21 CFR Part 11 requirements.
Audits