MediStat is a company specializing in statistical and data management solutions for
the correct and smooth carryout of clinical trials and epidemiological trials.
MediStat offers tools for automation of the research, throughout its stages, starting with the trial preparation stage,
through the trial execution stage and ending with the post-trial statistical analysis stage.
MediStat – Your Partner in Data Management and Statistical Analysis
MediStat has a strong foundation in software development for clinical data management and applied statistics.
We have built a comprehensive set of fully customizable solutions to make your trial run quicker, smoother,
and with high data quality from the design stage through statistical analysis.
The following sections explain how MediStat can help you in preparing the trial, executing it, and processing its results.
Trial Preparation
For a trial to be successfully carried out, you have to make sure the experiment is correctly defined.
Once the trial’s objective, scope and other basic parameters are defined, the following steps are mandatory:
* Write down statistical analysis plan
* Calculate sample sizes that will yield the expected statistical power
* Perform the needed randomization procedure
MediStat offers consultation services regarding these technical aspects of the trial preparation.
Trial Execution
MediStat has extensive experience in all aspects of the management of clinical trial data;
we can offer a solution that fits your needs.
You will benefit from an integral solution that uses our field-proven assortment of data management,
validation and reporting tools to accelerate the trial while keeping your confidence in data integrity, security and correctness.
The structure of the Case Report Forms (CRFs) is reflected in the trial database;
all aspects of data processing can be handled in a paperless environment.
The following sections illustrate how MediStat tackles all aspects of data processing.
Database Administration
MediStat will create and maintain the trial database: the computer infrastructure,
as well as the routine administration procedures (such as regular database backups).
MediStat will also guarantee the security of your data, protecting them from would-be intruders.
CRF Review Data Monitoring
We can provide professional assessment of data at all stages of the trial in order to locate problem
as early as possible, avoiding the costly effects of correcting such problems downstream.
Data Entry
You need high-quality data entry in order to ensure correct results. Our data-entry solution can be adapted for your needs.
We develop screens for data entry in the form of each CRF. This method enables quick and reliable data entry.
Specifically, we support both single-pass or double-pass entry, and can offer several degrees of entry automation using OCR techniques.
When using double-pass data entry, discrepancies are resolved on-line during the second entry. Missing data, or any other condition that violates the designed limits, causes the automatic generation of a request for clarification.
CRF Tracking
Knowing the state of the trial is one of the trial manager’s most important aims. In order to aid in trial management,
we can provide you with complete, up-to-date reports on the state of the trial, with any level of detail: from aggregate data down to an individual form. We perform logical tests during the process of data entry in order to minimize errors.
Clarification Requests
MediStat data management solution makes room for on-line analysis of CRFs and correction of missing,
wrong or inconsistent data by authorized professionals. We can design automated procedures to streamline
the process of data clarification.
Data Validation and Database Closing
Once all data is collected and discrepancies are resolved, a thorough review of the database
(before the statistical analysis is started) will help assess completeness and correctness,
weed out remaining errors and increase your confidence in the quality of the clinical data.
Our analysis tools can search through the trial database, and cross-reference the electronic
records to the CRFs in order to clarify all remaining inconsistencies.
The trial database can be accessible to other parties at your request.
Query and Report Generation
Throughout the trial, MediStat can provide you with custom queries and reports regarding
demographic data, relevant cross-sections of clinical data, adverse events,
concomitant treatments, etc.
MediStat can generate periodical, up-to-date reports on any aspect of trial management.
Another feature we can offer is to create “snapshots” of the database in order to perform
statistical analyses on incomplete or non-validated data for evaluation purposes.
Graphical Analysis
Many aspects of the clinical trial can be grasped quickly using graphical presentation.
We can offer customized graphics such as:
* Management data (patient enrollment, trial progress, completion)
* Demographic information (patient profiles)
* Cross-sections of clinical data
Post-Trial Statistical Analysis
Once all data are collected and validated, the time has come for the statistical analysis of the results.
Our professionals will perform all statistical procedures required by the protocol using the most advanced tools.
Our reports include tabular and graphical presentation for descriptive presentation of the data,
interim and final reports describing the data and the statistical analyses as well as the trials’ results.