Posted by Keith ward on Fri, Feb 10, 2012 @ 10:48 AM
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.
Posted by Keith ward on Wed, Oct 19, 2011 @ 01:46 PM
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 3rd 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
Posted by Keith ward on Wed, Aug 31, 2011 @ 01:13 PM
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 3rd 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.
Posted by Keith ward on Thu, Jul 14, 2011 @ 01:46 PM
Growing complexity of clinical trials, increased focus on data accuracy and cost is driving the market for CTMS to almost $2 Billion in the next few years.
Bound Brook, NJ – July 15, 2011- DZS Software Solutions Inc., a clinical research software organization focused on clinical trials and developers of the ClinPlus® brand of products announced today the launch of a CTMS CRO Program. The program provides access to DZS’s SaaS-based ClinPlus CTMS on a month-to-month subscription basis as well as installed or hosted delivery with a nominal set-up and training fee.
If a sponsor contracts with a clinical research organization (CRO) to run a trial on the sponsor’s behalf, the sponsor will most likely be looking for controls from the CRO. A CRO needs a tool that increases efficiency, productivity, capability, performance, and internal communication, as well as communication with the sponsor. A tool that helps decrease manpower, and administrative overhead also helps decrease associated costs. These benefits, in turn, can be passed on to a sponsor, giving the CRO a competitive edge.
DZS developed ClinPlus CTMS in response to the industry’s need for an affordable yet, highly-configurable and feature rich clinical trial management software. This program offers small and medium-sized CROs a tailored and proven clinical trial technology solution to include in their service offering.
By providing this more comprehensive CTMS service offering to their pharmaceutical, biotechnology and medical device clients using ClinPlus technology, CROs can compete more effectively with larger, full-service CROs, while still maintaining their own unique level of specialized service. “Smaller, more specialized CROs typically do not have the financial resources to invest in multiple, sophisticated clinical software applications, particularly if they are actively providing the detailed type of service that won the business in the first place. DZS recognizes this and has created a program to enable CROs to, easily and cost effectively, augment their core strengths with DZS/ClinPlus software, and increase their revenue as a result,” says VP of Product Development, Bob Borysko.
ClinPlus CTMS can be configured to track, measure and report on virtually every aspect of a clinical trial or study program. The relational database at the heart of the CTMS groups, analyzes and filters clinical trial operations information at various levels including, among others, trial, country, site, investigator, product, clinical research associate (CRA), etc.
As a result, the ClinPlus CTMS provides a view of trial management data suited to a variety of individuals within the organization, including high-level, consolidated metrics for senior managers, allowing them to view the progress of multiple studies and compare protocols in order to optimize future studies.
Joining the CRO Program does not require any capital investment, and among other benefits, partner CROs will receive preferred pricing on ClinPlus software and ancillary services, as well as joint sales and marketing resources from DZS.
Keith Ward, Director of Global Marketing for DZS Software Solutions, explains, "Our program is unique in that this offering is exclusively for small-to-mid sized CROs because they can benefit the most from adopting our technology platform, and they tend to be flexible enough to adjust their processes and take full advantage of what the CTMS technology has to offer.
To speak to a product expert or a personalized demonstration, please contact sales&marketing@clinplus.com or follow this link to request specific information or pricing:
http://tiny.cc/gzfyw
About DZS Software Solutions, Inc.
DZS Software Solutions, Inc. (www.clinplus.com) 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.
The ClinPlus® Software Solutions Suite’s unmatched cost-of-entry, scalability, flexible delivery options and exceptional training and support have gained DZS a reputation for delivering exacting quality and helping clients achieve early visibility to reliable clinical data. DZS software engineers possess decades of statistical analysis, clinical data management, clinical project management, and ADE/Drug coding and table/list/report building experience. This real-world experience is incorporated into every ClinPlus® system design and is evident in the reliability and enhanced features found in every system!
Keith W. Ward
Director of Global Marketing
DZS Software Solutions, Inc.
1661 Route 22 West,
Bound Brook, NJ 08805-1258
Office: (732) 764-6969 Ext: 129
Fax: (732) 764-6755
http://www.linkedin.com/profile
kward@clinplus.com
www.clinplus.com
Posted by Keith ward on Thu, May 26, 2011 @ 10:38 AM
GBI Research's research, "Lifesciences IT - 2011 Yearbook" provides key data, information and analysis on Lifesciences \IT that is being implemented by pharmaceutical companies.
GBI Research expects that information technology (IT) in the lifesciences industry will become a trendsetter, helping pharmaceutical companies mitigate current and evolving industry challenges. IT solutions utilized in the value chain of pharmaceutical companies help them to operate effectively and efficiently. GBI expects an increase in the adoption of IT by pharmaceutical companies looking to remain competitive in the market place.
The Lifesciences industry is pressurized by various challenges such as declining Return on Investment (ROI) on R&D investments, entry of generics and layoffs. These factors are responsible for the lifesciences companies to invest in information technology solutions. Pharmaceutical companies have found that experimental techniques are costly, time-consuming, and involve the use of large numbers of animals for testing and are adapting to computerized combinatorial chemistry applications. Pharmaceutical Companies are increasingly adopting e-clinical trial solutions in the drug development phase. Cutting down clinical trial cost is the driving motivation for the adoption of e-clinical trial solutions. Services offered by IT companies in clinical data management are costly but have been proved to save cost for the companies in the long run. CTMS and EDC will attract the highest investments in the future followed by data mining, electronic submission tools and RFID. Outsourcing helps a pharmaceutical company to reduce costs by 30-35% and this is one of the main reasons why pharmaceutical companies outsource non-core R&D operational work to IT companies. When selecting a country to outsource clinical data management work, building the required competencies to tackle client requirements has gained a higher importance than the cost advantage it provides. The predictive analytics helps a company view beyond the sales volume in to real time prescribing patterns, as a behavior of continuum. This also helps the company to follow the evolving niche buster model. Many pharmaceutical companies have increased satisfaction levels from their customers in 2008. In 2004, 50% of the physicians were satisfied on the current number of calls. However, satisfaction levels have increased in 2008 with more than 57% of the physicians in the US satisfied with the current number of calls. The increase in satisfaction levels was directly proportional to the decrease of sales force in the US.
Posted by Keith ward on Thu, Apr 28, 2011 @ 09:18 AM
One of the key emerging trends in the global pharmaceutical industry over the recent years is the rising number of post-marketing studies or Phase IV studies. In fact predictions are that the Global CTMS Market will grow to almost 2 Billion Dollars by 2017.
As many as 75% of drugs that received approval during the period 1998-2008 in Europe and the US were associated with commitments to carry out post-marketing studies.
About half of the drugs approved in Japan were also subjected to similar commitments. These studies are generally larger involving thousands of patients and clinical sites, which render specific challenges.
Clinical Trial Management Systems (CTMS) find significant application in these studies, owing to built-in workflows in these systems that enable easy implementation and modification for addressing unique challenges of these arduous studies.
Clinical trial management systems are also offered as a licensed, hosted, or SaaS-based solution. Features, compliance, functionality, security, and price are key determinants in selecting a CTMS.
Another trend in the market is the
integration of CTMS with other systems. (
see ClinPlus CTMS Integration with Medidata Rave) Vendors of standard-based open architecture are providing substantial assistance to biopharmaceutical companies in the area of integrating such systems. Service-oriented architecture provides a common platform that can be used in building solutions as interoperable services.
Posted by Keith ward on Tue, Apr 19, 2011 @ 11:12 AM
Medidata Solutions Reports Record Fourth Quarter and Full Year 2010 Results —
Clinical technology innovators continue to join the Medidata Technology Program, which now includes 12 partners, expanding the ability of customers to integrate additional applications with Medidata offerings. New technology partners in the fourth quarter include Logos Technologies, a provider of solutions for Phase I trials, and DZS Software, which provides clinical trial software products and clinical outsourcing services, including the ClinPlus® clinical trial management system.
A built-in standards-based framework supports automatic transfers of trial data from Medidata
Rave®, an industry-leading system for electronic data capture (EDC) and clinical data management
(CDM). The system leverages the Medidata Web Services API to automatically transfer critical trial
data collected in Rave into ClinPlus CTMS. This data sharing enables sponsors to improve clinical
productivity by reducing the amount of duplicate data entry and maintenance, increasing the
awareness of data changes through automated notifications and the acceleration of internal
processes such as investigator reimbursement approvals. ClinPlus CTMS 2.0 also supports data
import and export with other systems.
“The rapid sharing of trial data between Medidata Rave and the ClinPlus CTMS will help our
customers reduce their trial management burden and run more efficient trials,” says Glen de Vries,
President of Medidata.
With an efficient and error-free method of bringing trial data captured within Medidata Rave into
ClinPlus CTMS, DZS and Medidata can now serve their customers with rapid, automated transfers
of trial data, such as patient enrollment, patient visit, dropout and discontinuance data. The
integration with Medidata Rave allows users to schedule and manage import types, key fields, values,
data sets and visits.
Posted by Keith Ward on Fri, Oct 29, 2010 @ 11:59 AM
End-to-end Clinical Trial Management Software (CTMS)—long sought as the “holy grail” of fast and successful product development—is streaming into the life sciences marketplace.
As the central hub of all information and management in a clinical trial, CTMS offers potential for data sharing, transparent communication, and cost-effective streamlining of clinical development operations. In some vendor offerings, CTMS enables managing multiple trials at once.
Best-of-Breed vendors offer a single, comprehensive software system that pulls together electronic data collection (EDC), a Clinical Data Management System (CDMS), an Adverse Event Reporting System (AERS), as well as Interactive Voice Response Systems (IVRS), plus reporting and statistical analysis. It may be more than what buyers need currently – but would address many needs now and in the future.
Many emering to mediam sized biotechs, pharma and medical device sponsors however are simply looking for a way to start to manage trial operations and regulatory information data beyond the use of spreadsheets and disparate filing systems. The ability to share information with collegues, create alerts and provide audit trails for activities is mostly critical when your just getting started.
Best-in-Class Clinical Trial Management Software Features:
- Enables comfortable transition from paper-based, legacy clinical trial methods to all-electronic, Internet-enabled solutions.
- Offers a CTMS architecture that scales not only for enterprise growth but also to accommodate multiple trials.
- Provides a comprehensive solution capable of managing information and processes from EDC, CDMS, adverse event reporting systems, and IVRS, etc.
Top Considerations before Buying Clinical Trial Management Software:
A CTMS investment needs to be scalable, comprehensive in meeting client needs, and technology-ready for upgrades. That’s a must, especially in an industry undergoing consolidation yet, at the same time, projected by the likes of Software Insider to exceed $1.5B in software and services revenue by 2012. As a result, pricing is expected to be more favorable with pre-2012 vendor offerings.
Key Players:
1. IMPACT and TrialWorks are two CTMS solutions from Perceptive Informatics.
2. Clintrial, an automated, integrated software solution from Phase Forward Inc., provides CDMS, together with CTMS
3. StudyManager SE with Integrated CTMS from StudyManager includes site and overall aggregate study progress.
4. ClinPlus CTMS from DZS Software is an easily configurable latest entry .NET CTMS that can be delivered web-based or installed.
5. Office-Smart Clinical Trial Manager from BioClinica, Inc. leverages the Microsoft Office environment with Clinical Trial Process Manager (CTPM)
6. Siebel Clinical Trial Management System from Oracle’s Health Sciences group.
Posted by Keith ward on Sun, Jan 31, 2010 @ 08:45 AM
Pick any sector, any endeavor, any corner of the globe you like: 2010 promises to be a challenging year.
Although somewhat insulated from economic downturns due to the long development cycles of its products, pharma is certainly not immune to the malaise gripping the globe.
Certainly, one thing seemingly unstifled by the global downturn is the increasing complexity of managing clinical trials and data associated with clinical research.
As the number of sites on trials increases, so too, do the number of patients/subjects in the trials; getting sites initiated has become a process unto itself; paying investigators, managing contractor invoices, patient/subject cohort management, all grow more complicated every day.
To keep up, you need technology that keeps up: fast, flexible, web-based apps that can track subject visits, monitor visits, documents, payments, and inventories; something with good reporting options, easy-to-use metrics, and tools that automate wherever possible to produce cross-trial and even cross-study consistency.
These are some of the essentials we think the well-prepared clinical trial manager will look for in a CTMS this year:
• To make timely decisions, you need on-demand access to current trial data.
• The faster you can deploy studies, the faster you can conclude them. Look for flexibility to match your business processes and scalability to grow in your CTMS.
• Automate. Wherever, whenever you can. Loose the spreadsheets
• Quick access to study and regulatory guidance documentation helps quickly clear up any questions lost in translation from raw data to results during clinical trials
• Facilitate communication between teams. It's one of the hidden traps slowing organizations down more than they realize. Give your teams access to global contact databases and document repositories.
• The more closely you can manage investigator payments, the more control you have over budgets and how they're spent.
• Ensure 21 CFR Part 11 compliant, role-based security. Anything less is an invitation to disaster.
• Give managers and system administrators the tools they need to control access to features and data on a project by project basis.
If you'd like to see what a CTMS system can do for you, please visit our site and learn more even arrange a short demo.
http://www.clinplus.com/products/clinical-trial-management-software/ctms-demo/?utm_campaign=What%20you%20need%20in%20a%20CTMS-%202010&utm_medium=blog%20post&utm_source=CTMS%20Blog%20article&utm_term=CTMS
Contact DZS Today!
