Biostatistics Services

To ensure accurate interpretation of scientific data; biostatistics is an essential element of any clinical development program. At Advity, we offer you a wide range of biostatistics support and analysis optimised for study designs. We review study requirements and determine the best methods for collecting, analysing and presenting data in compliance with regulatory guidelines.

• Sample size calculations for clinical trials of any kind, including protocol reviews and co-authoring
• Adaptive trial design support
• Inputs in designing (e)CRF
• Analysis of all types of data – Clinical, Pharmacokinetic and Population Pharmacokinetic
• Programming of CDISC ADaM datasets, TLFs and metadata, ready for inclusion in the electronic Common Technical Document (eCTD)
• Interim analyses
• Preparing clients to present results to the FDA and EMAa

Data Management Services

Advity offers a robust 21 CFR Part 11 compliant clinical trial management system to support document tracking at various levels of trial execution. Advity is having strategic partnership with the full service Clinical data management service provider.

Our clinical data managers provide you with the optimal solution for your clinical trial that will allow your study to go from first patient in to database lock as quickly and efficiently as possible without compromising data quality or integrity.

• Database design, development, and maintenance
• Data validation programming and testing, inclusive of edit check and manual review specifications
• Data entry, if applicable
• Data cleaning and query management
• Medical coding using WHODrug & MedDRA dictionaries
• Serious adverse event (SAE) reconciliation
• Management and integration of local laboratory reference ranges with CRF data
• Integration, verification and reconciliation of external electronic data
• Database lock and archival
• Database transfer
• CDISC (SDTM) datasets for ready submission to regulatory markets