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
Company Details
- Employees
- 4
- Founded
- -
- Address
- 700 Promontory Point Ln,
- Industry
- Biotechnology Research
- NAICS
-
Research and Development in Biotechnology (except Nanobiotechnology)
- Website
- leadingedgecdmsolutions.com
- Keywords
- Clinical Data Management, EDC Programming, Clinical Information Technology, Biostatistics, SAS Programming.
- HQ
- Foster City, California
Leading Edge Cdm Solutions, Inc. Questions
Leading Edge Cdm Solutions, Inc.'s website is leadingedgecdmsolutions.com
Leading Edge Cdm Solutions, Inc.'s LinkedIn profile is https://www.linkedin.com/company/leading-edge-cdm-solutions
Leading Edge Cdm Solutions, Inc. has
4 employees.
View email and phone details for 4
employees at Leading Edge Cdm Solutions, Inc..
Leading Edge Cdm Solutions, Inc.'s industry is
Biotechnology Research
Leading Edge Cdm Solutions, Inc.'s top competitors are
Hart Clinical Consultants,
Godoy Medical Forensics Incorporated,
Princeton Pharmatech,
Cer-Specialists,
Livingwords Translations,
The Lotus Group Llc,
Growth Effekt,
Trial By Fire Solutions,
Miracle,
Bay View Analytics.
Leading Edge Cdm Solutions, Inc.'s categories are Biotechnology Research
Leading Edge Cdm Solutions, Inc.'s founding year is 2014
