It's all About the Data and MetaData

WHO Drug Dictionary User Group Meeting 9/19-9/20 in Princeton, NJ

Representatives from DZS software will be attending this year’s WHO Drug User Group meeting in Princeton, NJ on the 19^th and 20^th of September. 

As ClinPlus Coding has recently earned software certification from the Uppsala Monitoring Centre, DZS will be provided space for a table-top exhibit where coding experts from DZS will be available to answer questions about the ClinPlus software and discuss coding issues, techniques and procedures. 

 To register for this meeting, please visit http://www.umc-products.com/DynPage.aspx?id=75618&newsid=10893.   

Can multiple dictionary setups work in ClinPlus Coding?

 Multiple dictionary setups connected to a single dictionary build database?

This is how you would setup a new thesaurus for that clinical study.  You would create a new dictionary setup which points at the same dictionary build.  This setup will essentially have an empty thesaurus to which you can now add new thesaurus entries to.  Note that the thesaurus entries for this dictionary setup are stored in the SAME TABLE in the database as the thesaurus records for the other dictionary setup.

Dictionary Build  MedDRA 14

• The build definition connects to a database

• In the database, one thesaurus table is created to store all thesaurus entries

• The one thesaurus table stores all thesaurus entries for all dictionary setups linked to the build

 

CTMS gamechanger: What's so great about a Site Visit Report Tool?

Oftentimes, during a site visit, a Clinical Research Associate will update information and data in the system if they observe important issues or adverse events. Unfortunately, with many CTMS systems available today, not all of those changes will wind up in the final site visit report, creating silos of information or even worse, loss of information and data that might prove critical to the trial results.

DZS Software has addressed this issue and built an all new Site Visit Report Tool feature that enables CRAs and Project Managers to author and review trip reports, while managing the workflow from first draft through final approval.  This new feature will enable clients to configure report templates based on visit type and country, and to integrate CTMS data directly into the trip report.  Unlike many other trip report authoring tools, the data entered by the CRA while creating the report is deeply integrated with the main features of the CTMS to reduce data redundancy.  Updates to system data elements commonly found in the trip report sections such as regulatory documents, issues, enrollment, SAEs and deviations are done while creating the report and do not need to be re-entered into other areas of the system.

Clinical Trial Software? I need a Price …Not a sales pitch!

 "Price is the most specific piece of information customers use to understand the nature of an offering and not providing it makes people feel lost and reduces their understanding of a product line. We have miles of videotape of users asking "Where's the price?" while tearing their hair out." - Dr. Jakob Nielson, Web Usability Expert

Are you a Pharmaceutical, Biotech or Medical Device executive charged with finding ways to improve your clinical trial process by leveraging the latest technology? Are you frustrated that you are unable to adequately compare the various vendor’s offerings, particularly when it comes to defining the total cost of ownership? Are you adverse to talking to a salesman or being put into a lead nurturing program before you know if you can really afford their product? “Budgetary Information is the #1 item of interest prospects are looking for, but can't find, when they are researching new software solutions. If you don't provide it, someone else will. “ - Stefan Tornquist, MarketingSherpa

Well, now DZS Software Solutions’, manufacturers of the ClinPlus® brand of clinical trial software, is now offering self-service budgetary pricing on their website for each of their entire suite of products. The pricing utility is completely self-service and does not involve any DZS salesperson intervention or follow-up email marketing. The system provides pricing for both lease and purchase options, various numbers of users as well as implementation, training and validation script fees. How’s that for convenience when budgeting for upcoming business process optimization?

The technology DZS employs to accomplish this is called Echoquote http://echoquote.com. With EchoQuote™, when an interested prospect is on your website, they will be able to easily request budgetary information in seconds, even for complex solutions. They choose your items, enter their information and click "Get Budget Info".  If approved, the end user gets their "budgetary quote" and you immediately begin to build trust.  The entire process can happen in seconds, while the prospect is still thinking about your company. Want to check it out for yourself?

Simply go to the website at www.clinplus.com  and search on any of their products and look for the button below:

 

 

 

 

ClinPlus Report - Tier 1 Pharma authoring tool.

Are you considering a Data Management System with EDC?

 

Whatever your mode of entry, DZS Software Solutions has a solution!
As the industry slowly moves toward site-based entry, companies are finding it necessary to support multiple modes of clinical data management, oftentimes within the same study.
Electronic data capture has promised unsurpassed productivity gains for several years now, but reality is that there are still many life science organizations, particularly emerging to mid-sized Pharma, Biotech and Medical Device sponsors, conducting paper trials. 
ClinPlus Data Management supports paper-based and site-based entry with features such as role-based menus, electronic signatures, and site-based security.
In addition, ClinPlus Data Management offers:

 

1. Shorter term return-on-investment

 

2. A self-sufficiency learning curve that is much shorter than getting your staff up to speed with EDC processes

 

3. Less complex integration with legacy systems, projects and external systems

 

4. Greater latitude to adapt to different size and different phase studies

 

5. No need to export SAS data from within the system

 

6. CRF imaging techniques that facilitate side-by-side data entry

 

7. Full CRF tracking and query management capabilities

 

8. An extensive array of reporting capabilities.

 

If you've shopped around, and followed the technology trends you know that full EDC systems carry a hefty price tag, and often the technology support and hidden fees to keep the system running smoothly can catch up with you, making you wonder where the promised productivity is.

 

If you'd like to compare the ClinPlus Data Management/EDC system with others, we encourage you to use this handy tool to see the details: http://edcmarket.appspot.com/

This new version of the EDC Market Tool has been expanded to include additional features of EDC systems including Site Payments, Randomization, Inventory Tracking, Offline capability and integration with Electronic Health Records (EHR).

 

EDC Market is an attempt to bring together information on commercially available Electronic Data Capture systems in a way that makes it easier for potential EDC users and buyers to research the market.

 

Every EDC system is different and I have chosen a dozen features to try to make it possible to compare EDC systems in broad terms. The information for the survey comes from the vendors own websites and marketing materials. Capabilities may have been overlooked or given more weight that they deserve, this is a general guide only and a basis for your own research.

 

Cut Adverse Event and Drug coding time in half!

ClinPlus® Coding runs at unprecedented speed. Thousands of records are auto-coded in less than a minute, and details of each coding job, including WHO drug coding, are permanently maintained. The system supports all the most popular dictionaries, and can be used to maintain your own custom dictionary. Here's a quick overview...

  Buy or Lease ClinPlus Coding®, by 12/31 and SAVE 15%

 

With over 15 years of coding experience behind us, our latest release leverages leading-edge Microsoft.NET, SQL technology and the latest changes in MedDRA coding, WHO Drug coding (B-1, B-2 and C formats), ICD9 and ICD10 dictionary formats and evolving industry requirements, yet still retains the reliability and flexibility ClinPlus users have come to expect. Take advantage of these powerful features:

• Supports Phrase Substitution for unprecedented productivity
• Auto-Codes data in minutes, not hours
• Possesses intuitive, task-oriented, interface (GUI)
• Integrates to Data Management and EDC processes, easily
• Saves set-up time and training expense with single implementation
• Codes SAS®, SQL and ORACLE data
• Supports unlimited dictionaries, including MedDRA, WHO Drug coding (B-1, B-2 and C formats), ICD9 and ICD10, as well as custom dictionaries
• Provides multi-level drill down to ingredients and classification
• Codes automatically or manually to a Thesaurus
• Facilitates pre-defined and custom report capability

Prefer That ClinPlus Take Care of It? Looking to Outsource?
DZS/ClinPlus also provides the following Coding Services: 

• Project Coding Services from your data
• Custom Report Creation
• Integration to MedDRA coding, WHO Drug coding, ICD9 and ICD10
• Creation of Custom Dictionaries

 

For more information, please visit our website http://www.clinplus.com or click on the link, below:

       

http://tinyurl.com/3o45enu

 

CTMS 2011…No longer a choice of Free or High Price

Part of the problem with the current clinical trial management software sector is that there are few middle ground options. On the low end, oftentimes companies try to use readily available applications like Microsoft Access or Excel to easily set up their database. But as one thing leads to another, and one database can replicate into a dozen, creating a potential for much of the data to be corrupted or lost in silos. Particularly frightening is the practice of using Microsoft Excel spreadsheets to store investigator names and contact information. There's simply no way to know if a report based on a spreadsheet uses all of the data in a huge spreadsheet. If one cell or dependency is changed, the whole spreadsheet can be incorrect. While many organizations believe they have a homegrown CTMS, unfortunately, these type systems don’t provide support for multiple users, don’t maintain audit trails and can’t be validated, or even maintained properly over time. Additionally, a true CTMS provides visibility into more than one trial at a time—a limitation even the best EDC systems lack.

On the high end, many of the big three EDC/CTMS systems are expensive and not that easy to get started. Pricing usually includes a hefty set-up fee and complex fee structures based on user roles, study size and numbers of users.

The CTMS industry seems to be enjoying a renaissance of innovation, with new visibility as both sponsors and contract research organizations appreciate access to operational data that are a) not needed for regulatory purposes, b) not gathered by EDC systems and c) of high value in effective clinical trial oversight.

Enter, ClinPlus CTMS 2.0

This system offers pharmaceutical, biotech and medical device sponsors and contract research organizations (CROs) a VERY COST EFFECTIVE SOLUTION

  

with simplified delivery under a new SaaS subscription model, in addition to traditional installed and 3^rd party hosted delivery options. The system also offers enhanced functionality with site visit report authoring and review workflow, automated email notification of events and alerts, scheduled report execution with email delivery, enhanced EDC integration and improved data importing capabilities. Follow the link below for a deeper dive. http://www.clinplus.com/ctms-landing-clinplus-clinical-trial-management-system-ctms

How DZS Clinical Services made a data entry nightmare...all better!

The Situation: A large client had been conducting infectious disease studies worldwide for several years and had collected patient data on hundreds of patients and thousands of paper CRFs. 

The Problem: Unfortunately, because the patient data was collected at a variety of sites and in different ways, the CRF data wasn’t documented or presented consistently, making efficient double key data entry difficult. The data entry forms for the studies did not follow best practices for insuring rapid data input, often requiring the staff to reference ancillary data, jump from one place on the form to another or switch from straight text entry to mouse/click check boxes. While this may seem trivial, when data entry people have to change focus or switch from one method of entry to another, or look elsewhere for information, the resulting time loss can be significant especially across data entry groups who are on a strict timeline! The client understandably asked DZS Clinical Services to provide some expertise and assistance in order to complete this project on-time and within budget.

Solution: DZS Clinical Services, with over 25 years of experience in data management and a professional team of skilled employees, assigned a Project Manager. a  data managers and data entry people, who were quickly briefed on the requirements of the project and the expected timeline. Over the course of three weeks, data was entered remotely into the Clients’ system continuously from several thousand CRF pages. As the data managers became familiar with the project and some of the complexities of the data entry task emerged, improvements to the screen design were suggested for future screen design. Because of the speed with which the first phase of the project was done, the client decided to give DZS thousands more pages, more than quadrupling the original task .These additional pages were completed ahead of schedule, within budget and excellent quality.

The Future: Because the project was performed by skilled and experienced data management and data entry professionals, common bottlenecks were avoided and the project went much smoother and was completed earlier than if the client enlisted the aid of inexperienced data management and data entry staff.  As a result of completing the project earlier than expected, clean data was available earlier in the process for analysis and some immediate findings as to what medications and dosages were more effective for treatment of the disease were realized. Additionally, with suggestions from DZS as to how to more efficiently prepare screens and organize fields for input, data entry in future studies will be more rapid and efficient, cost less and allow research personnel to gain earlier visibility to future data, gain competitive advantage and realize greater return on their clinical research investment.

About DZS: DZS Clinical (www.dzs.com) is a full-service data management and biostatistics-focused CRO located in Bound Brook, NJ. We utilize our state-of-the-art clinical software to optimize data and information flow and report presentation. With very low employee turnover, we maintain a highly experienced and dedicated team of data managers, statistical programmers, medical writers and other clinical and biostatistics professionals who operate as a team and are familiar with client needs.

DZS to Preview New EDC and CTMS Products at SCDM 2011

Clinical Trial Technology Leader to Preview New Web-based EDC and CTMS Product Capabilities

Bound Brook, NJ, September 1, 2011 – DZS Software Solutions, Inc., a leading provider of ClinPlus^® clinical trial software and service solutions (www.clinplus.com), today announced its plans for the Annual Meeting of the Society for Clinical Data Management (SCDM), taking place September 11-14 in Baltimore, Maryland. The SCDM Annual Conference is the world's largest education event for clinical data managers and related professionals, attracting approximately 650 attendees from across North America and around the world.

DZS will spotlight several major new product releases for their data management, electronic data capture (EDC), coding and clinical trial management systems (CTMS) which broaden their already existing trial software capabilities in capture, management and reporting of clinical, operational and safety data.

ClinPlus EDC^® is an all inclusive, ASP .NET system that represents a three year effort by DZS to deliver a more flexible, lower cost alternative solution to larger EDC systems. ClinPlus CTMS 2.0 offers pharmaceutical, biotech and medical device sponsors and contract research organizations (CROs) simplified delivery under a new SaaS subscription model in addition to traditional installed and 3^rd party hosted delivery options. ClinPlus CTMS 2.0 offers enhanced functionality with site visit report authoring and review workflow, automated email notification of events and alerts, scheduled report execution with email delivery, enhanced EDC integration and improved data importing capabilities.   

These new product releases reflect DZS’s ongoing focus on improving clinical trial productivity and leveraging new web-based technologies that increase the value of trial data and improve the quality of that data to support regulatory approval for new compounds, biologics and medical devices. DZS/ClinPlus will host booth demos (Booth #317) to showcase the capabilities and interoperability between these latest clinical technologies.

 

For more information, please email: salesandmarketing@clinplus.com or visit http://www.clinplus.com

About DZS Software Solutions, Inc.

DZS Software Solutions, Inc. is a privately held company founded in 1996 providing clinical trials software for clinical data management and analysis to the biotech and pharmaceutical industry worldwide. Over 50 clients globally presently use ClinPlus^® software for data collection and capture, data cleansing, coding, analysis, clinical trial management and reporting. When the software is coupled with DZS services and training, many ClinPlus clients have dramatically improved productivity and maximized the value of clinical research investments and gained a competitive advantage to get medicines and products to market faster.

The ClinPlus^® Software Solutions Suite for Clinical Trials provides premium tools required by pharmaceutical companies, contract research organizations (CROs), biotechs, and medical device manufacturers to expedite clinical trials and meet the strict data formatting requirements of the FDA and other global regulatory agencies.