- Home
- /
- Full-service CRO Capabilities
- /
- Biostatistics and Data Management
Biostatistics and Data Management
Biostatistics and Data Management
With 25 years of legacy, Lambda Therapeutic Research, a trusted full-service CRO, excels in Biostatistics and Data Management—key pillars of successful drug development. Our team of data managers, biostatisticians, statistical programmers, and pharmacokinetic specialists delivers precise scientific planning and seamless project execution. By leveraging advanced technologies and adhering to stringent regulatory standards, we ensure the delivery of accurate, accessible, and reproducible high-quality data.
Lambda’s Biostatistics and Data Management team excels in precise data analysis for studies bound for global regulatory submissions, including prestigious agencies like USFDA, EMEA, MHRA, Health Canada, 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 High Data Quality and Integrity
Collaborating closely with sponsor project teams, our adept data management team meticulously designs specifications for data collection, organization and validation in clinical trials. This process, guided by our extensive knowledge and regulatory expertise, emphasizes cost-effectiveness, data security, and compliance.
Data Management Capabilities:
- eSource / eCRF designing complying CDASH standard.
- CRF annotations (aCRF)
- Data Management Plan (DMP)
- Database designing & Testing (UAT)
- Data Validation & Query Management
- Integration of data from external sources for consistency with CRF data
- Delivering clean, analyzable database, adhering to CDISC standards
- EDC Training for the site personnel
- Seamless operations across various commertical EDC platforms, including Lambda's indigenous 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 reliable trial results.
Biostatistics Capabilities
- Study Designing & Feasibility inputs
- Sample Size Estimation & Power Calculation
- Protocol inputs / review
- Statistical Analysis Plan (SAP) & Mock TLG shells
- Statistical Analysis & Reporting (SAR)
- Customized Tables, Listings and Graphs (TLGs)
- Early phase healthy subject (BA/BE/PK/PD) study data analysis
- Replicate study and Multi dose Steady State studies data analysis
- PK/PD modeling & Population PK study analysis
- Adaptive study design, Two-stage designs
- Late phase patient (PK/CE/TE) trials data analysis
- Robust Data analysis using industry-standard software like SAS® and Phoenix WinNonlin®
- Scientific inputs to the study conclusion & Report preparation
- Regulatory query response with scientific justifications & statistical results
Biometrics Group - Key Activities Across Study Phases
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, regulatory-compliant web-based Clinical Data Management System that seamlessly integrates with various tools such as IWRS, LIMS, and CTMS. It features a profile based on a Roles & Responsibilities matrix and ensures full compliance with 21 CFR Part 11 and applicable 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 across the sites.
- 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.
Partner with Lambda and Novum for expert Biostatistics and Data Management solutions, ensuring precision in your clinical development.
Let's Unveil New Therapies Together
Connect with our experts to leverage our proven track record of clinical research excellence.