Founded in 2014 LeCDMS has become a trusted partner to its clients, small to medium-sized biotechnology, pharma and medical device companies, taking care of their Clinical Trials needs. Our competence, devotion, energy and drive made us a friend, an adviser and a solid supporter of our client’s successes. To lower the cost, we utilize the modern technology and engage international teams of highly skilled professionals in USA, Europe, Russia, and Asia
Our Mission and Values:
The LeCDMS Data Management team enables the development of products that improve patient lives by:
How are we different:
When you work with LeCDMS, you work with the experienced and driven Clinical Data Advocates(CDAdvocates). You know we actively support you; you hear our voices throughout the study; we design the best processes to achieve your ultimate goal – bringing your product to the market. The result of our efforts is study data of the highest quality, integrity and compliance.
Our Data Management services include:
Our Clinical Database Experts (CDEx) will work closely with you to select the most-appropriate EDC solution for your organization, considering your budget and studies’ complexities. Then, they will manage the build your study databases, and support them throughout the trial until closure. LeCDMS has access to highly skilled EDC programmers all around the world, including US-based, if requested. Every programmer has been hand-picked by us, their skill level evaluated and trained to our processes. This is our guarantee – we will build your databases as timely and efficiently as expected.
Our team has experience managing multiple EDC systems that include:
Our services include:
It is best to involve an expert Biostatistician (Hi-Biostats) at an earlier stage of the study design. LeCDMS Hi-Biostats will work closely with the entire project team to ensure that the correct data is captured from the start and is ready for analysis. They apply scientific principles and therapeutic indication knowledge to support your study. LeCDMS Hi-Biostats will be driving study design, study conduct, confirming data collection element, perform analysis and reporting, and defend your trial before the regulatory agencies.
Our Biostatistical services include:
Programming various EDC databases (Medrio, MedNet iMedNet, ClinCapture, Open Clinica, Clinical Studio, Medidata Rave, Oracle InForm).
Our services include:
LeCDMS SAS Programmers (SAS-Pro) are an integral part of the clinical study team, and close partners with Hi-Biostats.
LeCDMS SAS-Pros have conducted numerous projects producing tables, listings and graphs, CDISC SDTM and ADaM submission-ready datasets and associated documentation. It is a team of US and worldwide hand-picked professionals, their skill level evaluated and trained to our processes.
Our SAS Programming services include:
Clinical IT services including implementation of mHealth, eSource, ePro, and system interfacing
Software Development and IT Services
Biostatistics & Bioinformatics Services
Clinical Data Collection, Analysis and Management Services
"The biostatistical support provided by Melissa from Leading Edge was outstanding. Melissa reviewed and rewrote the statistical portions of our clinical protocol for a complex FIH phase 1 trial in recurrent HGG. I really appreciate the way she reorganized it into clear objectives with corresponding endpoints and analysis."
Leading Edge CDM Solutions, Inc. has not received any endorsements.