Leading Edge CDM Solutions, Inc.

Biotechnology ResearchUnited States11-50 Employees

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

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