COMPREHENSIVE COMPARISON OF CDM TOOLS

COMPREHENSIVE COMPARISON OF CDM TOOLS

Oracle Clinical:

oracle

Oracle Clinical (OC) and Oracle Remote Data Capture (RDC) provide a single application and infrastructure for Electronic Data Capture (EDC) and Clinical Data Management (CDM). It’s a flexible tool that provides a significant reduction in time and costs to set up complex trials. Oracle Clinical’s global library enforces standards and consistency throughout the trials. It also offers the reusability of the DCMs, DCIs and procedures (Derivation and validation) and hence, studies can be built quickly than any other EDC tools.

One of the most important properties of OC is its security. Data can be extracted only by the administrators. Also there is a firewall between the Oracle HTTP Server (OHS) and the Web Logic Server. This provides assurance that access to these systems is restricted to a known networks route (only), which can be monitored and restricted, if necessary.

OC provides a variety of detailed reports about the study- blank patient record, CRF for a particular patient, list of derivations, list of edit check programs, etc. Accessing or reviewing the RDC pages are so quick. As we are getting the discrepancies within the RDC page itself, discrepancy management is so easy and clear for both univariate and multivariate discrepancies.

Some of the limitations of OC are there is no Randomization and no provision to store the study related documents (PDF Archiving) within the study. It does not have multilingual capability.

DataTrak:

data track

Being one of the leading and experienced EDC solutions, DataTrak provides almost every service to its customers. Most highlighted feature is its multilingual capability; with this they have succeeded to satisfy their customers all over the world. Being the registered CDISC consultant (in most of the CDISC standards), DataTrak offers two tools for trial design – drag and drop interface for rapidly prototyping studies and Data Architect (an MS Excel based study design method). With the single Data Architect file one can do the study setup, screen design, user creation, derivation, edit check programing etc. Their training and 24×7 support systems are very useful to all customers.

Post production changes are one of the toughest things in CDM; at the same time, DataTrak offers very easy deployment of a modified version with very less downtime. Features like ePRO, Randomization, PDF Archiving etc. add value to DataTrak.

Medrio:

medrio

This is a simple, fast, and affordable (paid service) tool for the collection of data in clinical trials. The most important feature of Medrio is its easiness in study setup and design. It provides almost every service required in Clinical research in an affordable rate. Document management, ePRO, Randomization, PDF Archiving etc. are some of the advantages of Medrio. A developer can define variables from the built in library or he can define his own variable. This increases the speed of study design. Form Rules, Skip logics are simply incorporated into this. No high end programming knowledge is required for both edit check and derivation programming.

OpenClinica:

open clinica

This is a leading open source EDC tool. OpenClinica runs on both Windows and Linux. With very few steps one can setup a study in OpenClinica. As its architecture file is based on MS Excel, the study design is also very simple; and it supports the re usability of study components as well. Regarding the discrepancy management, OpenClinica offers a simple and easy interface for query resolution. This helps in cleaning the data according to the set standards. Double data entry, On Demand Export, Data export in CDISC ODM xml etc. are adds to its value. Even though it is very easy to work with, its data extraction formats is not that much easy. As the event details also comes with each variable, it requires some manipulations after the data extractions.

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