CDISC
Data Management
Our clinical data management system is a powerful tool for the effective and flexible management of your project.
Clinical Data Management System
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.
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Case Report Form Design
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.
Database Design and Development
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.
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 includes:
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
Trial master-EDC platform
Trial master EDC platform provides convenient services from any smart device like phone and tablet in all sizes.
The TrialMaster Electronic Data Capture (EDC) solution makes it easier for coordinators, monitors and investigators to enter and manage their clinical trial data. This ease of use for investigative sites, coupled with smart monitoring abilities and analytical tools, download a wide range of reports with one click, extensive options for using videos, photos, defining electronic labs forms that are tailored to each site and more.
Using the "Trial Master" system in your research can guarantee you process optimization, prevention mistakes, and saving valuable time.
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.
Quality Control
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.
Medical Coding
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.
Pharmacovigilance
Medistat provides pharmacovigilance (PV) services, covering both drugs and devices.
We offer clinical safety management process which is based on a standard practice for the collection, recording, preparation, review, approval and reporting of all SAEs, DLTs and other safety information reported throughout the course of a clinical study. Our standards are consistent with all the requirements of the sponsors, and in accordance with the current Israeli MoH, ICH and FDA guidelines.
The primary advantage of Medistat over other companies is the setup, hosting and management of both clinical and safety databases (DB) within our EDC systems; the required data is directly extracted from the clinical DB to the safety DB, and thus meeting the heavy demand of data reconciliation.
We also prepare the supplementary documentation, for example the Safety Management Plan, SAE form etc, perform the coding of adverse events and medications, and automatically produce MedWatch and CIOMS forms for submission to the authorities, based on the data recorded within the DBs.