Our talented team of statistical analysts, all educated to master’s or PhD level, are fully dedicated to provide high quality statistics to streamline the drug development process throughout all clinical phases. The expertise of team is constantly leveraged as all statistical analysts undergo regular intensive training to enhance their industry standards and statistical knowledge. Persistently supported by our software development experts, our team is using innovative software tools to facilitate analysis and reporting.
We provide analysis and reporting services for various objectives including:
- Interim Analyses
- Clinical study reports (CSR)
- Data and Safety Monitoring Board (DSMB)
- Independent Data Monitoring Committees (IDMCs)
- Submission to regulatory authorities
- Integrated analysis (ISS, ISE)
- Abstract and Publication support
Our services include:
- SAS® Programming
- Development of Statistical Analysis plan (SAP) and Mock Table, Figures and Listings (TFLs)
- Generation of analysis datasets
- CDISC format deliverables (mapping to SDTM and ADAM)
- Development of CDISC documentation (Pinnacle 21 validation report)
- Production of TFLs:
- Input to CSR
We will be pleased to hear about your trial project and provide you with a tailored-made, cost effective biometrics solution.
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