ABOUT OUR COMPANY
ClinVigilant is a joint venture of GSC Technologies and Q Science Consultancy (QSC) which comes with potential combination of Information technology and technical expertise in clinical research / Pharmaceutical industry
Most Important Points:
- We follow industry’s recommendation and guideline to develop highly compliant system
- Management team is highly experienced for a development of IT solution in various domain including Clinical Research / Pharmaceutical industry
- We support our client (partner) for regulatory query
CENTRALISE SOLUTION
Data Management platform for In-house and multicentric trial (EDC and eCRF)
ADVISORY & AUDIT SERVICES
Hands holding till 1st inspection of the company
VALIDATION SERIVCE
Third Party Validation and 10 step validation as per GAMP5 & 21 CFR part
INDUSTRY KNOWLEDGE
Global Brand strong in IT solution and research industry / Pharmaceutical industry
REGULATORY ADVICE
Global Regulatory guideline complaint – 21CFR Part 11, CDISC-CDASH/SDTM
AUDIT SERVICES
Hands holding till 1st inspection of the company
OUR CORE SOLUTION
WE HAVE
PROFESSIONAL AND
COMPETENCE
IN OUR
SOLUTION
- INTERFACE IWRS/IMP/ Pathology Interface
- BARCODE base auto entry & verification
REGISTRATION
Healthy and patient database with unique identification
DESIGN OF ECRF
Library based designing on basis of SDTM and CDISC. Flexible and easy to design any type of clinical studies with customized edit check
SAMPLE MANAGEMENT
Management and tracking of all biological samples
SCREENING
Medical screening record both at generic and project level
DATA MANAGEMENT
Both offline and online data entry with online QC checks, review process and query management repository, management and tracking of IMP
DOSSIER MANAGEMENT
Single click dossier preparation with bookmarking and other regulatory requirements
SUSTAINABLE SOLUTION
Key Feature – EDC / eCRF
- Fully Integrated solution with Subject Registration, Medical Screening Platform, LIMS, Bioanalytical sample tracking
- tandard Review process, Auto Scheduling of activities, Compliance with Regulatory Norms to submit electronic communication
- Dynamic form layout, Barcode driven data, Global Form library compatible with CDISC / CDASH / SDTM
- No Programming effort needed for eCRF/ Database development, Global Audit Trial, compatible with any device, Export data in any format (xml, xls, csv etc)
Most Important Points:
- Simplicity
- Creativity
- Effectiveness
WHAT WE HAVE FOR YOU?
Initiate the project plan, business requirement documentation
Configure and customize the business process as per business requirement
Pre and Post Go Live support, stabilization of system, incident management and manage change request
Manage project plan, reports to stakeholder on weekly basis on status of the project, Project Governance