LLX Solutions
LLX Solutions is a biopharmaceutical services company dedicated to providing efficient, cost-effective, and high-quality clinical research services. Their mission is to support drug development by offering expertise in biostatistics, data management, CDISC implementation, consulting, and staffing services. With a team of experienced professionals, LLX Solutions aims to build lasting relationships with clients by delivering excellent services and innovative solutions across various therapeutic areas.
Industries
Nr. of Employees
small (1-50)
LLX Solutions
1400 Main Street, Waltham, MA 02451, USA
Products
Biostatistics and Programming
Comprehensive biostatistics and statistical programming services supporting clinical, pre-clinical, and patient-reported outcomes for pharmaceutical, medical devices, and biotech companies.
Data Management
Data management services for electronic data capture (EDC) clinical trials, including CRF design, database creation, data entry, validation, cleaning, and database lock.
CDISC Implementation and Submission
Services for implementing CDISC data standards, including SDTM mapping, ADaM data generation, and creation of Define.xml and related documents for submission.
Consulting and Staffing Services
Strategic consulting and staffing services covering trial design, sample size calculations, protocol writing, interim analysis planning, and regulatory guidance.
Biostatistics and Programming
Comprehensive biostatistics and statistical programming services supporting clinical, pre-clinical, and patient-reported outcomes for pharmaceutical, medical devices, and biotech companies.
Data Management
Data management services for electronic data capture (EDC) clinical trials, including CRF design, database creation, data entry, validation, cleaning, and database lock.
CDISC Implementation and Submission
Services for implementing CDISC data standards, including SDTM mapping, ADaM data generation, and creation of Define.xml and related documents for submission.
Consulting and Staffing Services
Strategic consulting and staffing services covering trial design, sample size calculations, protocol writing, interim analysis planning, and regulatory guidance.
Services
Statistical design and analysis services including trial design, sample size justification, randomization schemes, SAP preparation, data conversion, and production of statistical outputs and submission-ready datasets.
Full data management services for paper-based and electronic clinical trials including CRF and database design, data validation and cleaning, medical coding, database lock and transfer, safety database management, and EDC end-user training.
Comprehensive Data Monitoring Committee services including charter development, stopping criteria, independent reporting statisticians, meeting coordination, and production of DMC reports.
Services to implement CDISC standards including CDASH-compliant CRFs, SDTM mapping, ADaM generation, define.xml production, metadata repositories, and QC against CDISC standards for regulatory submission readiness.
Strategic consulting across study design, regulatory planning, and clinical trial rescue, plus staffing services providing contract or FTE placements for statisticians, programmers, and data management professionals.
Statistical design and analysis services including trial design, sample size justification, randomization schemes, SAP preparation, data conversion, and production of statistical outputs and submission-ready datasets.
Full data management services for paper-based and electronic clinical trials including CRF and database design, data validation and cleaning, medical coding, database lock and transfer, safety database management, and EDC end-user training.
Comprehensive Data Monitoring Committee services including charter development, stopping criteria, independent reporting statisticians, meeting coordination, and production of DMC reports.
Services to implement CDISC standards including CDASH-compliant CRFs, SDTM mapping, ADaM generation, define.xml production, metadata repositories, and QC against CDISC standards for regulatory submission readiness.
Strategic consulting across study design, regulatory planning, and clinical trial rescue, plus staffing services providing contract or FTE placements for statisticians, programmers, and data management professionals.
Expertise Areas
- Clinical trial management and study design
- Biostatistics and statistical programming
- Clinical data management
- CDISC implementation and regulatory data standards
Key Technologies
- CDISC (SDTM/ADaM/Define.xml)
- Electronic data capture (EDC) platforms
- Statistical programming and data conversion
- Data validation programming
News & Updates
Recent posts
LLX Solutions shares updates and insights on clinical research challenges and solutions.
Recent posts
LLX Solutions shares updates and insights on clinical research challenges and solutions.