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Leading Edge CDM Solutions, Inc.

1 Order Completed
Foster City, California, US

About Leading Edge CDM Solutions, Inc.

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... Show more »

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:

  • Promoting a warm team spirit and focused work environment that fosters knowledge sharing and encourages innovation
  • Collaborating with our clinical partners in designing and conducting scientifically sound clinical trials
  • Collecting, analyzing, and delivering quality clinical trial information dynamically and efficiently
  • Conducting our activities in compliance with all regulations and the highest ethical standards
  • Constantly looking for ideas and technologies that can help us provide the best possible solutions

How are we different:

  • We are a focused CDMA (Clinical Data Management Advocates) team. We select our professionals based on their passion, in addition to their expertise and experience
  • We form partnerships and friendships. Our voices are calm, confident, clear and supportive. We are there for you as you need us
  • We become a part of your Clinical organization that:
    • creates, maintains and presents through the use of technology quality clinical data, thus supporting 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
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Diversity Certificates

Small business Woman owned business Woman owned small business

Our Services (12)


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Data Management

Price on request

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... Show more »

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:

  • 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
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Clinical Electronic Data Capture (EDC)

Price on request

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... Show more »

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:

  • 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
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Biostatistical Analysis

Price on request

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... Show more »

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
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Software Development

Price on request

Programming various EDC databases (Medrio, MedNet iMedNet, ClinCapture, Open Clinica, Clinical Studio, Medidata Rave, Oracle InForm). ​

Our services include:

  • EDC and other supporting software selection
  • Database build, validation, amendments and migrations
  • EDC training
  • User and site management

LeCDMS SAS... Show more »

Programming various EDC databases (Medrio, MedNet iMedNet, ClinCapture, Open Clinica, Clinical Studio, Medidata Rave, Oracle InForm). ​

Our services include:

  • EDC and other supporting software selection
  • Database build, validation, amendments and migrations
  • EDC training
  • User and site management

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
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IT Consulting

Price on request

Clinical IT services including implementation of mHealth, eSource, ePro, and system interfacing

  • Process optimization
  • Vendor assessments
  • Solution implementation including AI driven mobile applications
  • Testing & validation
  • Training
  • Support and reconciliation

Clinical IT services including implementation of mHealth, eSource, ePro, and system interfacing

  • Process optimization
  • Vendor assessments
  • Solution implementation including AI driven mobile applications
  • Testing & validation
  • Training
  • Support and reconciliation
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Computer Science, Software Development, and IT Services

Price on request

Software Development and IT Services

Software Development and IT Services

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Data Services

Price on request

Data Services

Data Services

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Data Analysis

Price on request

Data Analysis Services

Data Analysis Services

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Statistical Analysis

Price on request

Statistical Analysis Services

Statistical Analysis Services

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Biostatistics & Bioinformatics

Price on request

Biostatistics & Bioinformatics Services

Biostatistics & Bioinformatics Services

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Clinical Research

Price on request

Clinical Research Services

Clinical Research Services

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Clinical Data Collection, Analysis and Management

Price on request

Clinical Data Collection, Analysis and Management Services

Clinical Data Collection, Analysis and Management Services

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Alec Budman

Chief Operating Officer
  • Positive review for Data Management:

    February 2019

    "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.