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Zifo offers a comprehensive range of clinical development services, both for traditional paper trials and EDC trials. Our services can be consolidated to a single package (delivering all services together) or customized to deliver only the services requested by the customer. |
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Zifo equips you with the right combination of personnel experienced in technology as well as domain to assure you with an accurate and timely database, a critical aspect of any EDC system. Excellent Project Management, powered by productivity tools and metrics based tracking, along with system-wide reusability enables us to meet aggressive timelines in handling setup of databases and integrating data sources and to validate clinical data thoroughly. |
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 eClinical Services / EDC Services |
 Study Build / Setup using EDC products like Phase Forward InForm, Medidata Rave, Open Clinica, e-Capture and Oracle Clinical
Integrations development with eClinical Systems like IVRS, CTMS, Central Lab, Data Repository and Safety applications
Custom Reports development using Cognos, Business Objects and Crystal Reports
EDC Technical Help Desk Support – Non voice support to resolve technical issues related to electronic data capture systems, User Management & Site Management in EDC Systems
Data Migration Services from legacy applications to latest EDC products or Clinical Data Repositories
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| EDC Consulting Services |
Technology & Process Consultancy during EDC Technology Adoption
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| Computer System Validation Services |
Retrospective & Prospective Validations of home grown applications
PQ validations for COTS products like EDC, CTMS and safety applications
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| SAS Programming Services |
Analytical Dataset, Tables, Listings and Graph development
Independent SAS Program Validations
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| Clinical Data Management Services |
Data Acquisition
Data Cleaning (Discrepancy Management)
Dictionary Coding Services
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| Remote Regulatory Compliance Audit of India based service providers |
| Highlights |
| Our Services methodology combines system / Tool based approach to improve productivity, consistency and quality, appropriate onsite offshore model for cost benefit, reusability to maximize effort spent and robust training methodology to manage scalability. Highlights are, |
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| Our Global EDC Study build methodology is EDC technology independent; System based approach is built in for improving reusability, workflow management, status tracking & reporting and metrics reporting. |
| Portal based project management, regulatory oversight (profiles & training records) and communication enables global accessibility and control to our customers |
| On-boarding & periodic refresher trainings are conducted based on our unique eLearning Kit which consists of technology, domain and process areas |
| Our reusable assets |
Library eCRFs – CDASH compliant eCRFs in multiple EDC technologies including Editcheck Specifications, logics and programs
Standard SAS programs for generating Tables, Listings and Graphs and other Macros
EDC validation package for User Acceptance Testing including
Validation Plan & summary Reports
Requirements
Traceability
IQ / PQ test scripts
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