We have extensive experience in providing biostatistical consulting services for study design and protocol development.

• Designing Statistical Analysis Plans (SAP)
• Coordinating and managing DSMB outputs and meetings
• Consulting on clinical trial design and protocols, including adaptive design studies
• Preparing Statistical Reports – Interim, Final and Clinical Study Reports
• Provision of CDISC:  SDTM and ADaM compliant analysis datasets
• Randomization support