CLINICAL RESEARCH AND DATA MANAGEMENT SYSTEM

MDM’s CRDMS was designed to be a solution for organizations that conduct clinical research while also providing a level of clinical data management. The system was designed to meet the basic needs of these organizations regardless of medical subspecialty while still allowing for the organization to customize it for its subspecialty. Below is a list of modules available for use in the CRDMS, as well as key features, and system compliances.

Modules and key Features
Case Management

  • Data capture and warehousing related to clinical management and patient care

  • Integration with other CRDMS modules

  • Quality Control

Clinical Data Management

  • Case Management

  • Decision Support Protocol

  • Rules-based clinical treatment

  • Clinical Notes

Specimen Tracker

  • Storage and tracking of specimens

  • Custom configuration of freezers and locations

  • Audit Management

Protocol Management

  • Ability to configure and administer multiple research protocols

  • Process Focus

  • Build and administer Case Report Forms (CRF)

  • Protocol summaries and ‘roll-ups’

  • Embedded exporting and reporting capabilities

Communication Center

  • Secure electronic communication between patient (or subject) and clinical provider

  • Ability to record details related to unscheduled calls between clinical provider and patient (or subject)

  • Knowledge Base Learning

  • Outcome Management

Survey Engine

  • Ability to create and send survey’s anonymously

  • Send survey’s to existing subjects in a protocol)

  • Embedded exporting and reporting capabilities

Document Management

  • Share Documents and collaborate with others

  • Version control of documents

  • Control access to folders or specific documents

General

  • Web based

  • Access and role based security

  • SSL encryption for secure transmission of data

  • Tools provided for self-administration

Compliance

  • HIPAA Compliant

  • FDA Title 21 CFR Part 11 compliant

Advantages

  • CRDMS features and modules exceed the scope of the traditional clinical research management software

  • CRDMS designed to be hosted in either in a DoD or a commercial facility

  • CRDMS will meet the core needs of clinical research organizations, but designed to be customized for each organization’s needs and workflow

  • MDM has both the knowledge and experience to modify or integrate the CRDMS as needed to meet an organizations specific needs

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