Meta-Xceed, Inc. Services
From sasCommunity
Meta-Xceed has a highly skilled and experienced team providing clients with support from phase 1 through the regulatory submission process. We have expertise in statistical programming, biostatistics, data management, medical writing and project management. Our services can be accompanied by our own software or we can develop customized solutions based upon the client's requirements.
Contents |
[edit] CDISC Services
- CDISC Compliance and Data Integrity Service
- Prepare Electronic Submission Documentation (define.pdf).
- Perform Systems Validation
- Write SOP and Guidelines
[edit] SAS Programming
- Tables, Listings and Graphs
- Analysis Datasets
- Validation of SAS Programs
- Patient Profiles and CRF Tabulations
[edit] Biostatistics
- Develop Statistical Analysis Plans
- Statistical Review of Tables, Listings and Graphs
- Produce Statistical Reports
- Represent Client at FDA Meetings
- Write Statistical Methods for Protocols
- Plan and Develop Protocols
- Design and Develop Clinical Plans
[edit] Medical Writing
- Write Study Reports
- Prepare NDAs
- Produce Protocols
- Generate Manuscripts
- Provide IND Updates
- Write SOPs
[edit] Project Management
- Manage the CRO Process
- Manage Budget, Timelines, and Deliverables
- Produce RFP and Review Bids
[edit] Data Management
- Design Case Report Forms
- Design Custom Databases
- Perform Data Entry
- Manage Discrepancies
- Provide Electronic Case Report Form Review
- Generate Monitoring and Status Reports
- Deliver Data in CDISC Models
For more information, please visit http://www.meta-x.com/services.html
