LAXAI's Data Management service offering addresses the recent regulatory requirements for CDISC compliance and encompasses GCDMP principles. LAXAI provides customized solutions aimed at reducing Data Management costs, improvement in data quality, portability of data for further analysis and accountability. Our cost-effective models allow us to combine resources for a custom approach that precisely meets your needs.
We support EDC, paper and hybrid studies on all major platforms available in the industry. Our Data Management Services are supported by a strong project management team to identify potential problems before they happen and keep the project on track. The Data Management team includes Life sciences graduates, Doctors, Database experts, Information Security, IT and Infrastructure specialists. We are a process driven company and we follow SOPs with rigor.
CRF / CDISC compliant Database Design
CRF Annotations
Study setup and configuration
Edit-check specifications and programming
Validation procedures
Test data entry
Double data entry
User Acceptance testing and multiple site rollout
Discrepancy management
AE and SAE reconciliation
External data load
CDISC ODM compliant data transfers
Database Lock and closeout
Data extracts
Data archival
LAXAI has strategic alliances with leading Data Management tool vendors to provide its customers a choice of the best paper based, EDC and hybrid tools available. We provide the following data management services using RAVE, Oracle Clinical, Oracle Clinical RDC, Inform and ClinTrial products.
Engagement Models
LAXAI provides both offsite and blended service models, a combination of offsite and offshore models for your Data Management. A typical offsite team structure would include a Project Manager, Clinical Data Manager, Clinical Database Programmers, Clinical Data Coordinators, Medical Coding specialists, DBAs and Data Entry Associates.
In a blended service model, offsite team would comprise of a Project Manager and a Clinical Data Manager and the offshore team will have an Offshore Data Manager and the rest of the team. Resource intensive activities such as data entry, medical coding and data clarification activities when pushed to offshore will result in significant cost savings, while Project Manager and Data Manager's presence in offsite, NJ ensures that communication channels with the client are efficient.
