Highlights

EDC software for BA/BE studies and clinical trials data management

EDC software for BA/BE studies and clinical trials is designed and implemented by us. The system supports biometrics integration for subject and patient registration, interface with the instruments of pathological lab, data management for various clinical trials sites and tracking projects of clinical trials and Phase I Bioavailability/Bioequivalence studies.

Sarjen now has successfully implemented a solution for BA/BE studies, Clinical Trails and eCRFs with seamless integration with LIMS (Laboratory Information Management) which in turn, interfaces with various Pathological lab machines and exchange information with the same. The solution uses biometrics and bar coded vaccutainers to make sure subject and data authenticity.

For details, visit KnowledgeNET...

Key Features:

  • Web based, easy to use intuitive interface
  • Scalable high performance system with advanced technology
  • Handles EDC for both BA/BE studies and clinical trials
  • Fully documented and regulatory compliance
  • 21 CFR compliance for access control and full audit trail
  • Multiple input device support to provide mobility while capturing key data
  • Dynamic design and integration facility to enable studies of various sizes and parameters
  • Dynamic reports formatting and designing capabilities with report templates can be designed in MS Word and linked with the database
  • Integration with Biometrics for authentic subject enrollment and patient registration
  • Role based system and work flow management
  • Queries and discrepancy identification, generation and resolution management
  • Can be used for multi center CRO and multi site study
  • Data exports to PDF, EXCEL, CDISC and SAS formats

Modules/Features:

  • Business Development and Project Study tracking
    • Inquiry and quotation tracking
    • Study slotting and monitoring
    • Project management and tracking dash board
    • Document management system
    • Drug PK details
  • Subject Registration and medical screening
    • Subject Registration
    • Biometrics Identifications
    • Electronic attachment of Proof (Scanned address/birth proof)
    • Photograph and Autograph capture of subjects
    • Subject Rejection - permanent
    • Online Quality Check and Quality Feedback
    • Design and print Patient Information Form
    • Project specific/Generic Screening forms and screening data capture
    • Attachment of X-Rays and X-Rays required report
    • Entry of Screening of Subject and related report
    • Online Tests requisition on lab and results of lab tests
    • Barcode generation and vaccutainer management
    • Complete Audit trail report for screening records
    • Study-Subject allocation and subject followups
    • Online Quality Check and Quality Feedback
    • Design and print MSR form
  • Protocol and eCRF design
    • Reusable Standard Libraries – Activities, Attributes, Validation Rules, CRF designs
    • Visit Scheduling and Subject Attendance
    • Subject Index card with barcodes
    • Dynamic eCRF Form design (sample collection time points, dosage, meal distribution, well being records), High value – low value alerts and alerts on specific value
    • Barcode generation for each time points and attaching subject with the vaccutainer
  • Data collection and clinical trial data management (CTDM)
    • Electronic attachment of subject consent forms
    • Randomization and treatment assignments
    • EDC – Eelctronic data capture and Remote CRF entries
    • Reference to global coding dictionaries (such as WHO DD, MEdDRA)
    • Data cleaning, validation and discrepancy management
    • Custodian activities forms
    • Pharmacovigilance – Adverse event capture
    • LIMS and Integration with various pathological lab machines: Vitros, Immulite, Sysmax, Urisys, Cobas, SRS

For details, visit KnowledgeNET...