Clinical Biometrics

Data Management:

The success of any drug product development mainly relies on relevant and accurate data. How the data are collected, analyzed, and represented has a significant impact on the successful progression of the drug from lab to market in accordance with regulatory requirements.

Our Clinical Data Management processes, expertise, and technology are developed to make each step of your clinical trial data management process more accurate and efficient for Phase I-IV in a wide range of therapeutic areas.

Our CDM Team is Well-Versed with:
• Current Good Clinical Data Management Practices (cGCDMP)
• International conference on harmonization Good Clinical Practices (ICH-GCP)
• 21 CFR Part 11 Compliance
• Health Insurance Portability and Accountability Act (HIPPA) Requirements
• Applicable Regulatory Guidelines

Katalyst’s End-to-End Clinical Data Management Services include:
• paper Case Report Form (pCRF) and electronic Case Report Form (eCRF) design, development, review, Tracking, and Processing
• Clinical Database design and development, Setup, testing, validation
• Clinical Trials Medical Terms Coding (MedDRA, WHO-DD, ICD-9 & Client Dictionaries)
• Clinical Trail Data Entry, Review, Analysis, Migration, Loading, validation
• Clinical Trial Data Collection, Storage, Protection, Retention, Analysis, Sharing, Reporting
• Clinical Trial Data Capture, Either Paper-Based or Electronic (EDC)
• Electronic Data integration and transfer
• Quality Control Activities
• Medical Dictionary for Regulatory Activities (MedDRA)
• World Health Organization Drug Dictionary (WHO-DD)
• Serious Adverse Event (SAE) Reconciliation
• Clinical Database Transfers
• Clinical Database Lock
• SAS datasets
• SAS XPORT transport files
• EDC Helpdesk Support 24/7
• On-Site and Off-Site Clinical Data Management Services

Data Analysis (Statistical):

Katalyst’s Statisticians & Statistical Programmers provide expertise and knowledge of wide Therapeutic Areas & Regulatory Standards including:
• 21 CFR Part 11
• ADaM
• Global Regulatory Guidelines

Our team of Biostatisticians and Statistical Programmers provides a full range of biostatistical services including sample size calculations, randomization schedule generation, blinding and unblinding procedures, statistical analysis plans, and statistical analyses.

Biostatistics Services:
• Clinical Trial Study Design
• Study Sample Size Calculations and Randomization.
• Statistical Inputs to Clinical Study Protocol Development
• Statistical Analysis Plan (SAP) Development and Interpretation
• Statistical Reports

Statistical Programming:
• SAS Programming as per CDISC (SDTM/ADaM) Standards
• Performance of Statistical Analysis
• Generation of Tables/Listings/Graphs (TLGs) and Validation
• Generation of Tables/Listings/Figures (TLFs) and Validation
• Performance of interim Statistical Analysis
• Stand-alone Statistical Reports
• Clinical Statistical and Study Reports Writing
• SAS Datasets Creation as per CDISC
• Program Validation
• Integration of Databases Across Protocols
• Integrated Summaries of Safety and Efficacy (ISS & ISE) for Regulatory Submissions.
• Summary of Clinical Safety and Efficacy (SCS & SCE) for Regulatory Submissions.
• Data derivation and mapping to CDISC standards
• Implementation of CDISC SDTM and ADaM standards