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| Data
Management and Data Analysis Service |
Qtech
Solutions provide clean data for analysis in a timely and
efficient manner. We use cutting edge data management technology
that is globally consistent. We can provide you with comprehensive
data management services for a new drug from Phase I through
Phase IV. The system is deployed globally with centralized
database servers accessible from all data management centers,
allowing us to coordinate data from large international
trials within a single study database. Qtech solutions have
coupled its clinical and data management groups together
to take full advantage of the efficiencies offered by Electronic
Data Capture (EDC). EDC allows the investigational sites
to electronically record data directly into the clinical
database, for availability to the sponsor once it has been
reviewed for accuracy and completeness by the clinical monitoring
and data management staff. A well-designed case report form
can streamline the entire data collection process. Qtech
solutions have several experienced CRF designers who incorporate
their clinical trial experience with their designing capabilities
to ensure absolute adherence to study protocol. We Design
at any stage between draft protocol and final protocol.
Standard templates can be utilized so that the CRF remains
in your desired format and appearance. All forms are designed
with the entire project team in mind to provide a CRF that
is easy to complete and that will collect data of the highest
integrity. |
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| Qtech
Solutions offers the following data management services: |
- Data management consulting.
- Case Report Form design, printing, distribution.
- Data management criteria and manuals.
- Data validation specifications.
- Database design.
- Customized data formats that are easily
integrated into the overall study database.
- Data receipt, logging, and tracking.
- Data entry (remote, traditional).
- Query generation, updating, tracking,
and resolution.
- Centralized data coding (COSTART, WHO
Drug, and MedRA dictionaries).
- Logical edit checking and validation.
- Data quality assurance.
- Data management reporting
- Database security/confidentiality.
- Secure Web access for online viewing
of individual study databases.
- Secure proprietary bulletin board system
for data upload.
- Comprehensive data analysis capabilities
- Contingency Planning.
- Clinical SAS programming
- Sample size calculations.
- Treatment randomization and code break
envelopes.
- Statistical analysis of clinical PK/PD
endpoints.
- Summary tables, figures and listings.
- Integrated Safety Summary (ISS)/ Common
Technical Document (CTD) tables/integrated summary of
efficacy((ISE)
- Statistical reports.
- Ad hoc data summaries.
- CRF design.
- Database design.
- Programming.
- Data quality validation
- Query management.
- Thesaurus coding/Lab data administration
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- Study close-out/database lock.
- Quality control and assurance (queries
and data) .
- Status reports (any format, including
web-enabled secure access)
- Pre-planned and “ad hoc”
summary reports .
- Electronic data transfers.
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