Services We Provide
Statistical Programming
We offer statistical programming services that leverage advanced techniques and programming languages such as SAS and R to analyze and interpret data effectively. Our expertise includes data manipulation, statistical analysis, visualization, and reproducible reporting, ensuring insightful and actionable insights for your business or research needs.
Clinical Data Management
We specialize in efficiently managing clinical data, implementing quality control measures, and facilitating accurate reporting to support evidence-based decision-making in healthcare and pharmaceutical research.
Biostatistics
We specialize in designing studies, analyzing data, and interpreting results to make informed decisions in fields such as medicine, public health, genetics, and environmental science. Our expertise ensures rigorous and reliable statistical analyses to advance scientific understanding and improve health outcomes.
Medical Writing
We provide the creation of clear, accurate, and scientifically rigorous documents for the healthcare and pharmaceutical industries. Our services encompass writing and editing a range of materials, including clinical study reports, regulatory submissions, manuscripts, and educational content.
Statistical Programming
- SAS and R programming.
- CDISC Implementation Support: Provide guidance and support to pharmaceutical companies, contract research organizations (CROs), and academic institutions in implementing CDISC standards across their clinical research programs.
- CDASH Implementation: Design and implement CDASH-compliant electronic case report forms (eCRFs) for data collection in clinical trials.
- SDTM Mapping and Conversion: Convert raw clinical trial data into SDTM-compliant datasets, mapping variables to standardized domains and variables as per CDISC guidelines.
- ADaM Dataset Creation: Create analysis datasets (ADaM) for statistical analysis and reporting, ensuring alignment with CDISC ADaM standards and regulatory requirements.
- Define-XML Generation: Generate Define-XML metadata files to describe the structure and content of clinical trial datasets, facilitating regulatory submissions and dataset interpretation.
- SEND Compliance: Provide support for Standard for Exchange of Nonclinical Data (SEND) compliance, including mapping nonclinical data to SEND domains and generating SEND datasets.
- CSR Programming and Production: Develop and produce CSR documents, including TLFs, narratives, and summaries, following CDISC SDTM and ADaM standards and regulatory guidelines.
- ISS and ISE: Statistical programmers integrate safety and efficacy data from multiple sources, including individual studies and pooled analyses, to create a comprehensive overview of the safety profile of the investigational product.
- CDISC Training and Education: Provide training workshops, webinars, and educational resources on CDISC standards and implementation best practices to support knowledge transfer and skill development within organizations.
Clinical Data Management
Data Collection Tools
- Select and implement data collection tools and electronic data capture (EDC) systems.
- Customize and configure EDC systems to align with study protocols and regulatory standards.
Data Validation and Quality Control
- Implement data validation checks to ensure accuracy, completeness, and consistency of collected data.
- Perform thorough data cleaning and query resolution to maintain high data quality standards.
Data Standardization and Harmonization
- Standardize data collection processes and data dictionaries across multiple studies or sites.
- Harmonize data from disparate sources to facilitate integration and analysis.
Clinical Data Reconciliation
- Reconcile data discrepancies between different data sources, such as CRFs, laboratory reports, and patient records.
- Perform data reconciliation to ensure consistency and accuracy across all data sets.
Clinical Database Management Systems (CDMS)
- Utilize and administer CDMS platforms for efficient data management and tracking.
- Provide user support and training for CDMS users to ensure optimal utilization and data integrity.
Biostatistics
Statistical Analysis Planning
- Develop comprehensive statistical analysis plans (SAPs) outlining planned analyses and statistical methodologies.
- Define primary and secondary endpoints, statistical tests, and data handling procedures to address study objectives.
Meta-Analysis
- Conduct meta-analyses to synthesize evidence from multiple studies and estimate overall treatment effects.
- Apply systematic review methodologies and statistical techniques, such as random-effects models, to pool data across studies.
Clinical Study Reports (CSRs)
- Compile detailed clinical study reports summarizing study findings, methodology, results, and conclusions.
- Adhere to regulatory guidelines (e.g., ICH E3) and industry standards for CSR preparation and submission.
Data Exploration and Descriptive Statistics
- Conduct exploratory data analysis to understand the characteristics and distributions of study variables.
- Calculate descriptive statistics, such as mean, median, variance, and frequency distributions, to summarize study data.
Consulting and Collaboration
- Provide expert biostatistical consultation and guidance to interdisciplinary research teams and stakeholders.
- Collaborate with clinical investigators, data managers, and regulatory affairs professionals to support study objectives and regulatory requirements.
Medical Writing
Clinical Study Reports (CSRs)
- Compilation of detailed clinical study reports summarizing study findings, methodology, results, and conclusions.
- Adherence to regulatory guidelines (e.g., ICH E3) and industry standards for CSR preparation and submission.
Clinical Study Protocols
- Preparation of clear and comprehensive clinical study protocols outlining study objectives, design, methodology, and statistical analysis plans.
- Ensuring alignment with regulatory requirements and ethical considerations for clinical research.
Patient Information and Informed Consent Documents
- Development of patient information leaflets and informed consent documents to facilitate participant understanding and compliance in clinical trials.
- Tailoring content to diverse patient populations and ensuring readability and accessibility
Regulatory Documents
- Drafting of regulatory submission documents, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).
- Preparation of Common Technical Document (CTD) modules, summary documents, and responses to regulatory agency queries.
