Biostatistics & Data Management
Lambda Therapeutic Research ensures the highest quality in Data Management and Biostatistics, crucial elements throughout drug development. Our adept team, comprising data managers, biostatisticians, statistical programmers, and pharmacokinetic experts, excels in precise scientific planning and project execution. With expertise in cutting-edge technologies and stringent regulatory compliance, we manage precise, accessible, and reproducible high-quality data.
Lambda’s Biostatistics team excels in precise data analysis for studies bound for global regulatory submissions, including prestigious agencies like USFDA, EMEA, MHRA, HC, PMDA, DCGI, ANVISA, and others. Our data science team is adept in CDISC (SDTM & ADaM) datasets, critical for studies intended for submission at USFDA and PMDA.
Data Management
Ensuring Data Quality and Integrity
Collaborating closely with sponsor project teams, our adept data management team meticulously designs specifications for data collection, organization, validation, and analysis in clinical trials. This process, guided by our extensive knowledge and regulatory expertise, emphasizes cost-effectiveness, security, and compliance.
Data Management Capabilities:
- eSource / eCRF designing following CDASH standard.
- CRF annotations
- Data Management Plan
- Database designing & Testing.
- Data Validation & Query Management
- Integration of data from external sources for consistency with CRF data
- Delivering a clean, analyzable database, adhering to CDISC standards
- TMF Management
- EDC Training for the site personnel
- Seamless operation in various EDC platforms, including Lambda's own customized EDC system, BizNET.
Biostatistics
Facilitating Efficient Trials
Our seasoned team of biostatisticians offers consultation on trial design, statistical methodology recommendations, programming expertise, and reporting accuracy to ensure efficient and punctual trial completion.
Biostatistics Capabilities
Study Designing & Feasibility
Statistical Analysis & Reporting (SAR)
Late phase patient (PK/CE) trials data analysis
Statistical Analysis Plan (SAP) & Mock TLG shells
Early phase healthy subject (BA/BE/PK/PD) study data analysis
PK/PD modeling & Population PK study analysis
Robust data analysis using industry-standard software like SAS® and Phoenix WinNonlin®
Regulatory query response with scientific justifications & statistical results
Protocol inputs / review
Adaptive study design, Two-stage designs
Sample size estimation & Power Calculation
Customized Tables, Listings and Graphs (TLGs)
Replicate study and Multi dose Steady State studies data analysis
Data analysis using industry-standard SAS® software.
Scientific inputs to the study conclusion & Report preparation.
- Study Designing & Feasibility
- Statistical Analysis & Reporting (SAR)
- Late phase patient (PK/CE) trials data analysis
- Statistical Analysis Plan (SAP) & Mock TLG shells
- Early phase healthy subject (BA/BE/PK/PD) study data analysis
- PK/PD modeling & Population PK study analysis
- Robust data analysis using industry-standard software like SAS® and Phoenix WinNonlin®
- Regulatory query response with scientific justifications & statistical results
- Protocol inputs / review
- Adaptive study design, Two-stage designs
- Sample size estimation & Power Calculation
- Customized Tables, Listings and Graphs (TLGs)
- Replicate study and Multi dose Steady State studies data analysis
- Data analysis using industry-standard SAS® software.
- Scientific inputs to the study conclusion & Report preparation.
Biostatistics, Programming & Reporting Capabilities
Protocol inputs / review
Pharmacokinetic sampling scheme
Statistical Analysis & Reporting (SAR)
Sample size estimation & Power calculation
Generation of Tables, Listings and Graphs
Study Design as per scientific rational & regulatory requirements
Regulatory query response with scientific justifications & statistical results
Report preparation and discussion
Scientific inputs for study feasibility
Scientific inputs to the study conclusion
Randomization Generation & IWRS support
Statistical Analysis Plan (with TLG mock shells)
Efficacy, Safety, Pharmacokinetic and Pharmacodynamic Analysis
Core Activities by Study Phase
Study Team for Biometrics
Expertise in Specialized Data Analysis
- In vitro data analysis for Equilibrium Binding & Kinetic Binding (e.g., Sevelamer, Colesevelam)
- Statistical testing for Particle Size Analysis data (e.g., Azacitidine Inj.)
- Two-stage study design (Adaptive study / Group Sequential approach)
- Data Analysis based on the latest OGD requirements like Scaling approach for NTI drug (e.g., Tacrolimus)
- CDISC (SDTM, ADaM) compliant datasets deliverables
- PK/PD modeling and Population Pharmacokinetic (Pop PK) Analysis & Reporting
- Data simulation and Profile predictions
- Data analysis for Late-phase trials involving Non-Inferiority, Superiority, and Therapeutic or Clinical Equivalence comparison
Clinical Data Management System (CDMS)
BizNET is a comprehensive and regulatory compliant web-based Clinical Data Management System, integrated with IWRS, LIMS, and CTMS, featuring profiles based on Roles & Responsibility matrix and compliance with 21 CFR Part 11 & GCP requirements.
Clinical Data Management Task
Our Exceptional EDC System
At the core of Lambda’s Biometrics services is BizNET®, an exceptional regulatory-compliant eCRF (EDC) platform that facilitates paperless and efficient project execution.
Key features and advantages:
- 24x7 software IT support
- Edit Checks prevent data discrepancies.
- Formula building avoids manual calculations for data accuracy.
- Synchronized Date & Time ensures precise study activity timing.
- eCTD Dossier Functionality for eCTD ready Subject-specific eCRF export.
- Randomization using IWRS for unbiased treatment allocation and accurate labeling.
- Bar codes for 'auto' data capture prevent redundancy, save time, and enhance accuracy.
- Fully configurable software
- Audit Trail provides detailed event tracking.
- User-Friendly Design & Usability ensures easy implementation.
- Standard Form Library accelerates study-specific eCRF development.
- Reusable Database Setup compliant with CDISC standards for efficient data entry.
- Comprehensive Reporting with customized data listings for effective review and action.
- Seamless Integration prevents data redundancy and integrates with various applications.
Expertise in Specialized Data Analysis
- In vitro data analysis for Equilibrium Binding & Kinetic Binding (e.g., Sevelamer, Colesevelam)
- Statistical testing for Particle Size Analysis data (e.g., Azacitidine Inj.)
- Two-stage study design (Adaptive study / Group Sequential approach)
- Data Analysis based on the latest OGD requirements like Scaling approach for NTI drug (e.g., Tacrolimus)
- CDISC (SDTM, ADaM) compliant datasets deliverables
- PK/PD modeling and Population Pharmacokinetic (Pop PK) Analysis & Reporting
- Data simulation and Profile predictions
- Data analysis for Late-phase trials involving Non-Inferiority, Superiority, and Therapeutic or Clinical Equivalence comparison
Let's Unveil New Therapies Together
Connect with our experts to leverage our proven track record of clinical research excellence.