 eCRF design and Database deployment to 21 CFR Part 11 compliance
Database deployment to support Adaptive Design methods to make early decisions
Planning and implementation for submission ready data strategies based on CDISC, SDTM and ADaM datasets
Data Programming including SAS software capabilities
Medical coding in MedDRA and WHO Drug
Streamlining and reconcilling across SAE, CTMS, and study DB
Cross functional data review to identify and resolve issues
Functional outsourcing services for data management with capabilities in over 100 countries
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Pharm-Olam is a member of the Clinical Data Interchange Standards Consortium
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Expert EDC Deployment
The right EDC system for a study is determined by both project deliverables and budget. Pharm-Olam’s data management team has experience developing and deploying EDC study systems across several leading vendors including: Phase Forward, Medidata, Datatrials, DataTrak, and Oracle Clinical (paper). |
We can provide recommendations of systems designed for your study requirements or work with your preferred platform. In either case Pharm-Olam will plan and implement a quality data process that will generate accurate, complete and reliable data.
Data Project Managers Pharm-Olam provides Sponsors with an empowered Data Project Manager (DPM) to ensure the process and data structures are properly established from the onset to provide capture of clean data at the source, minimize queries, and maximize the speed of query resolution.
Our DPMs also coordinate biostatisics and medical writing functions so that all team members are aware of customer requirements and can maintain quality and deliver in time. |
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Contact us to speak with our Data Management experts |
Download Data Brochure |
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