Data
Entry & Data Management Services
CRMi
has entered into an alliance with Quartesian, LLC, a full-service contract
data management and statistical services firm. Through this alliance
CRMi provides comprehensive data management services at competitive
rates.
Quartesian is a privately-owned Contract Research Organization dedicated
to providing the most effective data management, programming and statistical
services possible. Quartesian's statisticians, programmers, data managers,
and database analysts are familiar with the many facets of the drug development
process. They provide superior service by paying attention to the kind
of details that only experienced people would be aware of. Procedures
and practices are in line with industry best practices.
Data Management
- Databases built in Clintrial®, with data definitions,
code lists, database triggers and primary key definitions. Standard data
edit and integrity checks written in PL/SQL®, SAS® or other
vendor products.
- Time from data import or last CRF page "in house" to
database lock minimized.
- Cost-saving options are available for data entry from
case record forms, including data entry groups based in the US and in
India.
- All deliverables
compliant with current good clinical practices (cGCPs) and 21CFR11 guidelines.
Quartesian's Intelligent Query System maximizes clarity and intent
of database queries while minimizing the effort required for sites to
respond. The majority of data queries generated pose specific questions,
propose specific answers, and employ check boxes or simple numerical
answers.
Programming
Quartesian's primary programming tool is SAS® Software. Standard
macro utilities, code management and version control are routinely used.
Expertise includes:
- CRF Tabulations for Regulatory Submissions
- Client-specified
Table Formats for Electronic Submissions
- CDISC-compatible
SAS Datasets, File Format Engines including XML, SAS Utility Programming
Tools
- Pharmacokinetic and Laboratory Data Management
and Reporting
Statistical Services
Quartesian's staff of PhD- and Masters-level statisticians
can handle any data analysis challenge. They work closely with CRMi, Inc.
or client clinical managers to generate the most clinically-relevant
and cost-effective results. Services comply with ICH recommendations
for statistical principles and reporting, and include:
- Statistical sections of protocols, sample size calculations
and randomization schedules
- Statistical analysis plans (SAPs), specifications
for case report tabulations and statistical reports.
- NDA/sNDA/BLA/510K submissions as well as submissions
for product labeling, launch preparation and postmarketing publications.
- Pharmacoeconomic study
designs.
- Pharmacokinetic/Pharmacodynamic Analyses
- Mathematical modeling, resampling
and bootstrapping methodologies, meta-analyses, data mining, and dose-response
modelling.
- Learn more about Quartesian, LLC
- Other Data Management Options PharmData, Inc
