Our biostatisticians have the expertise to support your needs in clinical study protocol development, statistical planning and data review, statistical analysis, and statistical report preparation.
Electronic Data Capture
The use of electronic data capture (EDC) solutions has grown dramatically over the past few years. Although paper data collection was once the preferred method in the clinical trials industry, EDC is now considered the gold standard for its many advantages.
EDC solutions allow for better data quality, adaptive clinical trials, and reduced time to database lock.
A solid EDC solution allows collecting, cleaning, reviewing, verifying and approving clinical trial data in an easy, efficient, and safe manner. The objective is to increase overall productivity and improve the quality and integrity of the data, which is why companies constantly migrate to EDC systems.
EDC System solution inculdes:
1. Project familiarization/Start-up (developing)
2. Users set-up and Management
3. Data management plan, including data validation program
4. Lab data import & reconciliation
5. Programming of status reports and additional reports by clients request
6. Project management
7. Database design and completion
8. Data backups – daily
Clinical Data Management System
Our clinical data management system is a powerful tool for the effective and flexible management of your project.
Our data management system is adjusted to accept new projects with different needs. We provide online access to the data in various formats, enabling you to view the data at your convenience. Data can be exported to datasets or other formats of your design and choice.
We design and plan the CRF according to the study protocol. Our CRF designs assure that the data recorded on them will support your protocol objectives.
The clinical database is developed from your protocol and CRFs for precise data storage and reporting. We document the database design and fully validate the database to guarantee its functionality and stability.
Our data conversion programs are designed to your specifications for the final database transfer, and we provide converted datasets for interim review.
Database Design and Development
Case Report Form Design
Double Data Entry and Reconciliation
Independent double data entry and reconciliation is one of the most reliable methods of data capture and minimizes database errors. Two different operators enter the data independently, while the data is blinded for the second operator.
The system checks for discrepancies between the databases. When completing the second entry and resolving all discrepancies, the data is transferred to final files.
We continue the comparison process until all data errors are resolved.
In advanced EDC systems the data is captured in real time and monitored.
We employ a variety of tools to guarantee the quality of your data including verification checks, data reviews, and quality control audits.
Based upon your protocol and specific requirements we develop and validate verification checks.
Our verification checks include logic, range, across form, and consistency checks of the clinical data. Based on the verification checks, the system produces queries which are sent to the CRO for correction or verification. Periodically, we conduct quality control audits to assure database integrity and adherence to medical and data review conventions.
MediStat uses data dictionaries to standardize variable attributes.
Diagnoses, adverse events and indications are classified using MedDRA dictionary or ICD9 code, as necessary.
Medications are classified using World Health Organization (WHO) Drug Public Website Dictionary, which employs the Anatomical Therapeutic Chemical classification system.