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Biostatistics & Data Management

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:

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.

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