Pharmacokinetics and Bio-statistics (PB). Dedicated and experienced team of biostatisticians implement technical knowledge to support you through the entire clinical development process. Our team has experience in all the phases of research and development from pre- clinical analysis to clinical and post-marketing services across various therapeutic areas. We deliver high quality and Complaint services, cost effectively. All the PB procedures are as per ICH standards, regulatory guidelines and performed in accordance with well-defined SOPs, checklists and documentation. Transform raw data into consistent, accurate and reliable trial outputs in compliance with regulatory guidelines. Focuses on expediting the regulatory submission process and shorten timelines through innovative thinking and unflinching commitment to quality.
CAPABILITIES
Sample Size estimations
Generation of Randomization
Pharmacokinetic (using WinNonlin) and Statistical (using SAS) analysis
CDISC Deliverables ( SDTM, ADaM, define.xml and XPTs )
Preparation of Statistical Analysis plan and report
SAS programming for interim and final analysis
Providing support for regulatory and advisory meetings
EXPERTISE
Certified SAS programmers with rich experience in developing safety and efficacy TLFs
Complete Data Management services from CRF Design, Deploying the database, Query generation to Database Lock (DBL) for both eCRF & Paper studies