Data Management & Statistical Analysis

Meta-Clinical is committed to providing you with the best data operation services in CRO. We have a proven track record of delivering high-quality results within budget and timeline. We have worked with many clients across various therapeutic areas and phases of clinical trials. We are confident that we can meet your expectations and help you achieve your research goals.

product details

product description

description1

description2

Meta-Clinical

Meta-Clinical is committed to providing you with the best data operation services as a CRO. We have a proven track record of delivering high-quality results within budget and timeline.

We have worked with many clients across various therapeutic areas and phases of clinical trials. We are confident that we can meet your expectations and help you achieve your research goals.

Data management (DM) is the process of collecting, validating, cleaning, and organizing data from clinical trials. Our DM team ensures that the data is accurate, complete, consistent, and compliant with regulatory standards and protocols. We use advanced software and tools to design, build, and maintain databases, as well as to perform data quality checks, query resolution, coding, and reconciliation. We also provide data analysis and reporting services to help you interpret and present your results.

CRF design, review, annotation CRF, CCI

Database design and set-up

Developing Data Management Plan and Report

Developing Data Validation Plan

Data entry and comparison

Data validation and cleaning

Query generation and resolving

Serious adverse events reconciliation

External data reconciliation

Medical coding

Support data review meeting

Data quality control

Statistical programming (SP) is the process of creating and executing programs to perform statistical analysis and generate tables, figures, and listings (TFLs) for clinical trial outcomes. Our SP team has extensive experiences and expertises in various programming languages, platforms and standards, such as SAS, R, Python, and CDISC. We follow the best industrial practices and guidelines to ensure the quality and validity of our programs and outputs. We also provide validation, documentation, and submission support services to help you meet the regulatory requirements.

Analysis of Dataset (ADS) Development

CDISC SDTM Data Mapping and Transfer

CDISC ADaM dataset programming

Programming for Protocol Deviation

Programming of Statistical Analysis Population

Database lock and transfer

Statistical Programming

Programming of tables, listings, and figures

Biostatistics (BS) is the application of statistical methods and techniques to analyze and interpret data from clinical trials. Our BS team consists of qualified and experienced biostatisticians, who can provide you with sound statistical advices and solutions for your research questions. We can assist you with study design, sample size calculation, randomization, protocol development, statistical analysis plan (SAP) writing, interim analysis, final analysis, and interpretation of results. We also provide statistical review and consultation services to help you address any issues or challenges that may arise during the course of your study.

Protocol develop/review

Statistical related recommendations, sample size calculations

Randomization schemes

CRF design/review

Data verification plan review

Developing statistical analysis plan (SAP), statistical analysis report(SAR)

Preparation of Statistical tables, data listings, and figures

Statistical analysis/consulting

Statistical verification

Recommendation and review of clinical study report(CSR)

Data Monitoring Committee (DMC) support