Data Management & Biostatistical

Bodhi Global Solutions offer services specializing in Biostatistics, SAS programming, Application Development & Data management Services. Our Skilled workforce combines clinical expertise and innovative processes to deliver a smarter approach to the conduct of clinical trials. We understand that each study comes with new challenges; we pride ourselves in proactively identifying & then effectively overcoming them.

Clinical Data & Operation Management

• Clinical trial management
• Clinical trial supplies management
• Clinical data management
• Clinical data repository
• Scientific and medical writing
• Lab data operations
• User acceptance training
• Discrepancy management
• SAE reconciliation

Biostatistical & Statistical Programming

• PK-PD, safety, efficacy, ISS/ISE, health outcomesanalyses
• IND and annual safety updates
• Specification document creation and mapping of CDISC domains
• SDTM and ADaM – development / validation
• Tables, listings, and figures
• Macro development / validation
• Development / validation of define.xml
• UI testing for macros
• Protocol and SAP development with TLF shells
• Clinical study reports
• Adhoc statistical analyses

Other Services

• CRF Design and annotation
• Coding medical dictionary
• Customize patient profiles
• E-submission
• Provide permanent and contract resources