Building on the advantages of standardization, the Clinical Data Interchange Standards Consortium (CDISC) has provided extensive guidelines for the collection, analysis and submission of clinical trial data for regulatory compliance purposes. Today CDISC standards are widely accepted by the industry and regulatory agencies, therefore necessitating the need of conversion of existing data into CDISC standards.
Our thorough understanding of CDISC standards, superior statistical programming capabilities and integrated tools and processes enable us to deliver CDISC compliant deliverables with greater efficiency.
OUR CDISC SERVICES
- Conversion of Legacy raw data into SDTM datasets
- Compliant Submission Data Packages – SDTM annotated CRF, define.xml
- Analysis ready ADaM domains, ADaM define.xml
- Validation documents and OpenCDISC Report
- Reviewer’s Guide
- SDTM/ADaM Compliant Integrated Databases
We follow a three-pronged approach to deliver high-quality CDISC services to our clients:
- Established procedures, work instructions and checklists
- Defined workflow to generate SDTM and ADaM standard data packages
- Validation and verification strategy to ensure integrity and accuracy of deliverables
- Project management to ensure smooth project execution
- Expert programmers with prior domain experience
- Exposure to implementing CDISC standards in diverse therapeutic areas
- Emphasis on continuous learning and training to remain abreast with latest standards
- Use of latest technology framework like OpenCDISC/Pinnacle21 Validator to ensure adherence to standards
- In-house Macro library with pools of SAS macros and utilities to achieve efficiency in the conversion process
- Automated system to generate Define.XML
Our large, global scale enables us to provide expertise and support to meet your needs in an efficient and high-quality way. Your data is the most important outcome of your clinical trial and is the result of a huge amount of investment – make sure you maximize it to its full potential.
Getting the right outcomes out of your clinical trials is all about the data and insights they provide. Biostatistics in clinical trials isn’t just a necessity. Using the right approach, with expertise in biostatistics and clinical trial institutional knowledge, it can be a competitive advantage.
At Lambros, we take an integrated approach. Seasoned biostatisticians apply their deep regulatory knowledge to help you navigate the complexities of study design, including sample size, number of studies, analysis methods, data displays and interpretations. With a global pool of experts and resources, providing speed and flexibility with study reporting.
Working with emerging global pharmaceutical Companies, we deliver the trial-performance analytics and the timely insights you need to make the decisions that benefit your patients. Our clinical data analysis fuels your clinical trial success, from planning stages through execution to reduce costs and risks, while accelerating timelines and improving quality of submissions.
We turn information into power for you.
- Statistical Input to Protocol/Study Design Development
- Sample Size Estimation
- Randomization Schedule
- Statistical Analysis Plan (SAP) and Mock-up Shells
- Analysis of Safety, Efficacy Data for CSR and Regulatory submissions
- PK/PD Analysis
- Integrated Safety and Efficacy Analysis (ISS/ISE)
- Analysis for BA/BE Studies, Meta-Analysis
- Support Safety Monitoring, Interim and Exploratory Analysis, Manuscripts and Abstracts
- Patient Profiles/Safety Narrative
- Statistical Report Writing
Our focus is to add value to the clients with our expertise in standard statistical reporting tools and systems. Our team is dedicated to providing services in compliance with current industry standards and regulatory guidelines. 21CFR-Part11 compliant systems and well documented SOPs are the back-bone for project implementation. We are up-to-date with evolving industry standards, changes in the regulatory environment and enhancements in technology and applications.
The wide repertoires of projects we have delivered span multiple therapeutic areas across the drug development lifecycle. Our focus on automation and process optimization, combined with the ability to customize solutions that are tailored for client-specific environments, make us a trusted partner with pharmaceutical companies and CROs to deliver high-quality analysis results.
Lambros is uniquely positioned to provide a wide range of Statistical programming services to our clients in a space where timely delivery and accuracy is of paramount importance.
- SAS Programming – SDTM/Adam Datasets and Tables, Listings, Figures
- Design and Deployment of System-level SAS Macros
- CDISC Implementation Service
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