|
Clinical Data Management Services
Best Biotek has capabilities in Data
Management system activities that are run on globally proven
and specialized software like SAS 9.1, Oracle Clinical 4.5.
To ensure that our data management capabilities meet
stringent quality standards, we validate our clinical
databases and software in compliance with the regulatory
bodies and 21 CFR part 11 environments.
Services under Data Management include:
-
Case
report form design and Review
-
Data
management plan
-
Database
setup & validation
-
Double
data entry
-
CRF Log
and Tracking
-
Clinical
Data Review
-
Query
Management
-
Interim
Analysis
-
Coding
in MedDRA,
WHO-DRUG, COSTART and ICD-9.
-
SAS
programming
-
QC check
-
Database
lock
|
SAS Programming
|
|
SAS Datasets Creation |
|
Data Listings, Tables, and Graphs |
|
Program Documentation |
|
Program Validation |
|
Version Control and Archiving |
|
Electronic (e-NDA) Submissions |
|
Integration of Databases Across Protocols |
|
Integrated Summaries of Safety and Efficacy |
|
Data Analysis
and Medical Reports |
|
Creating Tables, Listings, Graphs as per regulatory
compliance |
|
Generating Reports and Documentation as per FDA
requirements |
|
Protocols |
|
Interim and Final clinical study reports |
|
Investigator’s brochures |
|
Investigator’s new drug applications |
|
Integrated summaries of efficacy and safety |
|
Manuscripts |
|
Abstracts
|
|
