Flexible CDM Solutions for Optimal Results 

DATA MANAGEMENT

EDC

PROGRAMMING

CLINICAL IT

BIOSTATISTICS

SAS

PROGRAMMING

An Unrivaled Approach

We are a focused Clinical Data Management Advocates team. We select our professionals based on their passion, in addition to their expertise and experience. We strive to ensure our clients' needs are met, as well as form long-lasting partnerships and friendships with all our vendors and sponsors.

We care about the success of your clinical trials, and we are there to support you when you need us.


We become a part of your Clinical organization that:

 

  • Creates, maintains, and presents through the use of technology, quality clinical data that supports accurate and timely statistical analysis

  • Adheres to all the applicable standards, laws and guidelines of quality and truthfulness in scientific research

All this shows in the work we deliver.

Data Management

Designed with you in mind

When you work with LeCDMS, you work with 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:

  • 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 (Data Management Plan, Data Transfer Agreements, CRF/eCRF guidelines)

  • Data listings, metrics and reporting

 

EDC Programming

We guarantee efficiency, accuracy and affordability

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. We 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 including:

  • Medrio

  • MedNet iMedNet

  • ClinCapture

  • Open Clinica

  • Clinical Studio

  • Medidata Rave

  • Oracle InForm

Our services include:

  • EDC and other supporting software selection

  • Database build

  • Database amendments and migrations

  • Database validation

  • EDC training

  • User and site management

  • Lab and other data uploads

 

Clinical IT

A clean interface to ensure success

LeCDMS hires experienced and serious Clinical IT Masters (CITMs) resources to build the interfaces between your clinical databases and support other clinical systems. Clean interface can be the difference between your product’s success or failure.

 

Our Clinical IT services include:

  • Process optimization

  • Vendor assessments

  • Solution implementation

  • Training

  • Testing

  • Validation

  • Support and reconciliation

 

Biostatistics

Scientifically driven design & analysis

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:

  • Protocol – Statistical section

  • Study randomization

  • Sample size determination

  • Statistical Analysis Plan

  • Statistical Programming Plan and overseeing SAS programming

  • Statistical analysis & reporting

  • Biostatistical consulting

  • Investigator meetings

  • Support for regulatory submissions

 

SAS Programming

A worldwide network of handpicked professionals

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:

  • Develop and test SAS programs for complex analyses

 

© 2019 by Leading Edge CDM Solutions. All rights reserved.

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