Clinical Data Management/EDC
ClinSearch is able to manage both paper CRFs and eCRFs for your study. Due to the recent rise of eCRFs, more than 90% of the studies we manage utilize eCRFs.
Over the past few years, after careful consultation with all parties involved in a clinical study (monitors, Project Managers, investigators, site coordinators, sponsor representatives), ClinSearch’s Healthcare IT department has developed EDClinTM, an EDC platform superior in its intuitiveness and capacity to adapt to the unique requirements of each study and sponsor. Based on users’ feedback, EDClinTM excels at providing a simple-to-use interface and query management system; a variety of customizable data access, reporting, and storage options; and clean, error-proof data, immediately available for analysis.
EDClinTM has an integrated solution to upload imaging (DICOM files) and other documents. To ensure the highest compatibility, it’s an HTML5-based solution that doesn’t involve installing a desktop application. Investigators can easily import exams from a CD/DVD or the file system, using drag and drop. The DICOM module of EDClinTM offers online viewer and de-identification to comply with patient privacy regulations.
The EDC is customized at the beginning of each study and managed throughout its duration by the IT and data management departments. All tasks for the EDC set-up and management are performed in house, with the strictest adherence to our SOPs and Quality standards.
EDClinTM is based on the following technologies:
- Java Platform Enterprise Edition (Java EE):
– Enterprise Beans for security and System-level services,
– JavaMail: for mail notifications,
– Restfull request/response for low latency
– Web Services for data transfers between Mobiles apps and SPONSOR’s business intelligence tools;
- Oracle Database 12c Relational Database Management System (RDBMS) for data storage.
The EDC System developed by ClinSearch complies with 21 CFR part 11 of FDA recommendations.
Please contact us to schedule a demo.