Leading Edge CDM Solutions, Inc.

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 reporting EDC 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 uploads SAS 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 programming BIO 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 submissions CLINICAL 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