WITH US, IT'S ALWAYS PERSONAL.We are experts in end-to-end clinical data management. Founded in 2014, LeCDMS has become a trusted partner to its clients, ranging from small to medium-sized biotechnology, pharma, and medical device companies.WHY US: As a lean boutique company we avoid bureaucracy and are focused on your success by providing quality personalized services: - We provide any DM related services on an as-needed basis.- You will work directly with a project manager who is an expert in your study. The PM will ensure that your study will have the team's full attention no matter how big or small it is.- We hire only experts. You will always get an "A" team that knows your trial from study start-up to submission. - To lower budget requirements, we utilize modern technology and engage cost-effective resource allocation.DATA MANAGEMENT / CLINICAL DATA ADVOCATES- CRF/eCRF design- Setting up data validation checks- EDC User Acceptance Testing- Data query management- Data entry- Monitoring data support (we prepare the Monitors for their visits, and support while they are at the site)- AE/SAE reconciliation- Medical coding (MedDRA, WHO Drug)- Device accountability- Compliant Data management documentation (DM Plan, Data Transfer Agreements, CRF/eCRF guidelines)- Data listings, metrics, and reportingEDC PROGRAMMING / CLINICAL DB EXPERTS- EDC/other supporting software selection- Database build in a variety of platforms- Database amendments and migrations- Database validation- EDC training- User and site management- Lab and other data uploadsSAS PROGRAMMING / SAS-PROS- Statistical Analysis Plan- Analysis dataset specifications- Develop and validate SAS programs - Tables, Listings, and Figures- Data Extracts and Reports- CDISC SDTM, SEND and ADaM data conversion- CDISC documentation - Ad hoc or exploratory programmingBIO STATISTICS / HI-BIOSTATS- Protocol – Statistical section- Study randomization- Sample size determination- Statistical Analysis Plan- Statistical Programming Plan - Oversee SAS programming- Statistical analysis & reporting- Biostatistical consulting- Investigator meetings- Support for regulatory submissionsCLINICAL IT / CLINICAL IT MASTERS- Vendor assessment and advising on technology - Solution Architecture, Design, and Development- Mobile, AI/ML Intelligence, and Enterprise Applications- System integration- Validation and Q&A including automated testing- Training, support, and reconciliation

Website: LeadingEdgeCDMSolutions.com

Employees: 11 - 50

HQ:

Location: , California, United States

Revenue: