Much of the data collected during a clinical trial is collected at different sites, by different physicians, in different time-zones, and increasingly in different cultures. This situation as well as other factors leads to inconsistencies and variation in the data that is entered into fields on the Case Report Form (CRF).
One of the greatest challenges in achieving clean data is to somehow control the consistency of terminology throughout the study.
The solution for the varying fields of data within a clinical study is a process referred to as medical coding. The data originally entered is compared and matched with standard libraries or dictionaries and updated with clinical terminology that is uniform and acceptable to regulatory agencies. Coding can be done automatically (computer-aided), manually or a combination of the two. The more consistent the clinical data, the more reliable the data analysis, the integrity of the final clinical study report, and the eventual marketing authorization submission to regulatory authorities.
- DZS/ClinPlus has developed the most flexible clinical coding solution in the industry, which is guaranteed to meet all your adverse events (AE) and drug coding needs.
- ClinPlus® Coding is the industry's most powerful coding tool allowing users to meet all of their coding challenges with unmatched speed and accuracy.
- With over 15 years of coding experience behind us, our latest release represents a complete re-engineering of the original product. It leverages leading-edge Microsoft .NET, SQL technology and the latest changes in dictionary formats and evolving industry requirements, yet still retains the reliability and flexibility ClinPlus users have come to expect.
ClinPlus Coding System Highlights
Multiple Dictionary Support
ClinPlus® Coding supports virtually any dictionary including MedDRA, WHOdrug (B-1, B-2 and C formats), COSTART, WHOart as well as custom dictionaries and multiple versions of the same dictionary. The country and ingredient information, found in the WHODrug C format dictionary, is utilized during both the auto and manual coding function. Here's an introduction to the WHODrug Enhanced dictionary.
A single implementation saves valuable set-up time and reduces your training expense
The product supports a single deployment in either an Oracle or SQL Server environment and allows coding of Oracle, SQL Server and SAS data. Regardless of the configuration, installation, project set-up and training require significantly less time than any other competitive products.
A task-oriented, user-friendly interface (GUI)
Our totally new, task-oriented user interface is extremely intuitive, and facilitates quick navigation to required tasks and promotes more rapid user familiarity. And if you get stuck, there's a comprehensive context-sensitive help library just a click away.
Achieve outstanding hit rates during auto-coding
ClinPlus® Coding runs at unprecedented speed. Thousands of records are auto-coded in less than a minute and details of each coding job are permanently maintained.
Phrase Substitution Support puts YOU in total control
ClinPlus® Coding's support for phrase substitution lists dramatically increases your hit rates. These lists allow you to take full control for substitution, removal or modification of single words, phrases or any information contained within the qualifiers. For example, you can substitute "blood pressure" for "bp" or substitute the suffix "s" for "ing", effectively changing words like "feels" to "feeling".
You can also use phrase substitution to remove entire words or phrases. For instance you can remove the words "really" and "bad" so terms like "really bad headache" will match "headache". Qualifiers such as parentheses may also be used to remove extraneous information. For example, fever (101.5) would match "fever". All matches that are possible are presented as suggestions in ranked order for your selection.
Maintain Consistency and Control
One of the biggest challenges when coding is maintaining consistency but still retain the ability to control your coding decisions. With ClinPlus® Coding you can do both easily because the system "learns" as you code. After auto-coding, you can load all un-coded records and leverage various search options to help you find the right match quickly and easily. You can also choose to perpetuate your decision to other records with the same verbatim text. Additionally, you can choose to automatically add your coding decisions to a thesaurus for use in future coding sessions.
Maintain terms and medications not found in your dictionary
ClinPlus® Coding comes with a supplemental thesaurus that maintains terms or medications that either are not found in the main dictionary, or are used to override dictionary coding. Additional terms/meds may be added during manual coding sessions with administrator approval.
Multiple SOC (System Organ Class) or ATC (Anatomical Therapeutic Class) codes
When you encounter codes that link to multiple SOC or ATC codes, you can choose these yourself or let the system assign the dictionary default. Or, when auto-coding, you can set the system to pre-select the default or primary path as defined in the dictionary
Stay compliant by keeping track of all decisions!
With ClinPlus® Coding, every code assignment and method is recorded in an audit trail that provides access to the coding history on each record, along with summary information for each auto-coding job. All of these coding decisions may be reviewed and eventually marked as approved. The audit trail will record the details of every approval.
Produce a variety of custom reports
The report interface allows you to produce a variety of the pre-defined coding reports such as; All Terms, Un-coded Terms, Coded Terms, Multiple Body System/ATC, Frequency Counts or Coding History. Simply subset your data and tailor any number of reports by choosing the variables to include, rearranging the columns, changing the sort order or pagination, and then simply "save as" a user-defined report. The system is also flexible enough that you can create your own custom reports from scratch.
Increase coding consistency without losing your flexibility
Accuracy and speed are both extremely crucial to successfully meeting your coding challenges. ClinPlus® Coding achieves both by reducing your need to manually code while at the same time, increasing consistency, with virtually no loss in system flexibility.
When data is collected during a clinical trial, it is typically collected by different physicians at more than one site. These sites may be in different time zones and even among different cultures. These factors lead to inconsistencies and variations in the data collected and entered into the Case Report Form. ClinPlus offers a flexible clinical coding solution that will meet all of your adverse events and drug coding needs so that you can code SAS or code SQL with ease! Their software is the solution to achieving clean data through the control of consistency of terminology throughout the study.
Medical coding is the solution for the varying fields of data within any clinical study with the data that is originally entered being compared and matched with standard libraries or dictionaries and updated with clinical terminology that is uniform and acceptable to regulatory agencies. Some medical coding is performed automatically by a computer or it can be done manually. You can also use a combination of automatic and manual coding. The important thing is to consistently code the clinical data so that you get reliable data analysis and maintain the integrity of the final clinical study report. This will lead to eventual marketing authorization and submission to regulatory authorities.
The ClinPlus Coding System will allow you to code SAS or code SQL data with ease and save you valuable set-up time while reducing your training expense. Regardless of the configuration, installation, project set-up and training will require significantly less time than any other competitive products.
ClinPlus Coding offers the most flexible coding solution for your clinical trials management and is guaranteed to meet all your adverse events and drug coding needs. ClinPlus has more than 15 years of coding experience behind them and their latest release represents a complete re-engineering of the original product. ClinPlus Coding leverages leading-edge Microsoft .NET, SQL technology and the latest changes in dictionary formats and evolving industry requirements while still maintaining its reliability and flexibility.
With its task-oriented, user-friendly interface, ClinPlus Coding is an extremely intuitive, task-oriented system that promotes more rapid user familiarity. For those times that you might get stuck, the comprehensive context-sensitive help library is a click away. The software supports virtually any dictionary including custom dictionaries and multiple versions of the same dictionary. ClinPlus Coding runs at unprecedented speed with thousands of records being auto-coded in less than a minute and details of each coding job are permanently maintained. It has never been faster or easier to code data than with the ClinPlus Coding code SAS procedures!
You can maintain consistency and control over your coding decisions with ClinPlus Coding. The system “learns” as you code so that you just auto-code, load all un-coded records and leverage various search options to help you find the right match quickly and easily. You also have the choice to perpetuate your decision to other records with the same verbatim text and can automatically add your coding decisions to a thesaurus for use in the future.
Go to www.clinplus.com to learn more about this great system and to order a demo to see how much easier your medical coding can be. Call 1-866-ClinPlus begin_of_the_skype_highlighting 1-866-ClinPlus end_of_the_skype_highlighting to get more information and start enjoying the ease and flexibility of ClinPlus Coding.
Complete Coding Integration
One of the primary challenges facing organizations tasked with clinical trials is logistical. The sheer amount of data being processed, as well as the myriad coding parameters used to sort that information (such as WHO Drug coding and MedDRA coding guidelines), can create potential gaps in data management that will cause days or weeks of lost time and effort. Most of the data from any modern clinical trial is often gathered by researchers on opposite sides of the globe, in different time zones, or in different cultural environments. This can cause the work to be hindered by language barriers and by differences in procedure and coding specifications. MedDRA codes and WHO Drug codes differ significantly, even when posted in identical languages, and the added difficulty of crossing borders makes simple clinical data management a nightmare for many organizations.
ClinPlus Coding allows your organization to work under a single umbrella, and within a predetermined set of coding libraries, ensuring that all clinical information remains organized and cogent. Regardless of whether your organization uses WHO Drug coding or MedDRA coding guidelines—or even a proprietary coding library—ClinPlus Coding lets you keep your entire workforce on task and aligned. Since maintaining consistency in clinical study language and terminology is a prerequisite to gathering usable data, the organizational alignment ClinPlus Coding offers you is a powerful way to increase the efficiency of your study across the board.
DZS Software Solutions, Inc. has over fifteen years of experience in managing and assimilating coding libraries, and our system will integrate quickly and completely with MedDRA codes, WHO Drug codes, or any other form of specified coding library. On the back end, ClinPlus plugs straight into nearly all known database technologies and formats, from SQL to SAS and everything in between. Your information and technology department will appreciate the streamlined programming of our software suite, and our world class technical support channels provide a constant point of contact for any technical issues your team encounters.
Even better, the speed of the ClinPlus Coding software suite is astounding. Our system enables your organization to code literally thousands of records in under a minute, and all the details of each record are perfectly maintained in a 21 CFR Part 11 compliant manner. This provides not only unmatched work output, but perfect consistency across all your clinical data, even if different coding libraries are implemented on a case-to-case basis. ClinPlus Coding translates freely between MedDRA codes and WHO Drug codes, allowing your organization to operate freely without being constrained by the individual specifications of WHO Drug coding or MedDRA coding guidelines, generating even more speed and efficiency.
Best of all, the ClinPlus systems simple-to-learn and easy-to-operate user interface, makes training new employees or retraining existing employees a snap. Rather than being forced to learn input and output procedures for a dozen different systems, your organization can operate within a single user environment, swapping information on trial and patient information easily and translating between MedDRA codes and WHO Drug codes on the fly.
For more information on why ClinPlus Coding is right for your organization, contact our sales and support department.