Perceptive Informatics Improves Clinical Trial Management with New Release of Impact® CTMS Solution

Boston, MA, U.S., April 3, 2013 — Perceptive Informatics, a leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (NASDAQ: PRXL), today released an enhanced version of its comprehensive IMPACT® clinical trial management system (CTMS). Notable features include improved data entry as well as site management and monitoring capabilities. The system is designed for pharmaceutical and biotechnology companies of all sizes, and has more than 26,000 users in studies of up to tens of thousands of subjects and millions of visits.

According to market research firm MarketsandMarkets, the CTMS software industry is expected to jump from $567.2 million in 2010 to $1.3 billion by 2016.[1]  Perceptive Informatics’ CTMS solution provides a user-friendly infrastructure that enables clinicians to manage trials of varying complexity.

“Many top global pharmaceutical companies and CROs rely on the IMPACT CTMS solution to plan, administer and track every aspect of their clinical trials,” said Nick Richards, Vice President, Product Management, Perceptive Informatics. “As clients face further globalization of clinical trials and require site management and monitoring of increasingly complex studies, they need technology that keeps pace. Perceptive’s enhanced system represents a significant leap forward in flexibility and usability, enabling clients to improve the speed and effectiveness of their clinical development programs.”

Perceptive’s enhanced version is a customizable system which allows managers the flexibility to define which information is most important to their clinical trial and configure it accordingly. Highlights include:

  • Configurability by Clinical Trial Type – Customers can define their own clinical trial types – from single-site investigator-initiated studies to large multi-country studies – enabling them to select the critical screens and fields that each requires. This simplifies and streamlines clinical trial management and ensures that users see exactly what they need.
  • Assistance for Field Monitors – The IMPACT® MySites™ Module, which supports online and offline monitoring activities and the collection of associated management data, now enables contract research associates to record and manage contacts for the sites they monitor, allowing them to have a more comprehensive view of site activity.
  • Improved Data Mining Capabilities – The IMPACT® Investigator Module’s advanced search feature enables users to select physician names based on their location, specialty, therapeutic interests, responses to qualification questionnaires and investigator performance metrics in order to speed the finalization of candidate study sites and the recruitment of optimal investigators for a trial.

Perceptive Informatics’ IMPACT CTMS solution is used to plan, track and report on clinical trials and is available as a hosted, software-as-a-service (SaaS) application. It is an integral part of the Perceptive MyTrialsTM platform, which provides an application framework to converge its integrated suite of clinical trial software. For more information visit: http://www.perceptive.com/ctms/impact

[1] MarketsandMarkets, “Clinical Trial Management Systems (CTMS) Market: Global Trends, Opportunities, Challenge and Forecasts (2011 – 2016),” January 2012.

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Tampa General Hospital Selects Merge CTMS for Enterprise Clinical Research Platform

CHICAGO, Jan. 24, 2013 (GLOBE NEWSWIRE) — Merge Healthcare Incorporated (Nasdaq:MRGE), a leading provider of clinical systems and innovations that seek to transform healthcare, today announced that Tampa General Hospital selected Merge’s CTMS for Investigators solution for enterprise-wide management of its clinical trials.

Tampa General Hospital’s goal was to increase efficiency and centralize their business operations. They sought a CTMS to manage more than 500 active studies annually across all therapeutic areas, and track study activities for over 100 study coordinators. Billing compliance, financial accountability, patient and enrollment tracking, and reporting for management oversight were all important criteria in selecting a CTMS system.

“With the continued growth of clinical trial activities, we needed a better way to streamline data collection and reporting, as well as a more accurate method for tracking billing activities. We had previously relied on data collected in spreadsheets and multiple databases, and a time-consuming process to produce reports,” said Beth Kohl, Manager, Office of Clinical Research at Tampa General Hospital. “We sought a CTMS that would centralize and organize our research operations to replace numerous manual and fragmented methods of capturing and recording data. After evaluating several CTMS systems, we felt that Merge CTMS provided us the standardization needed, as well as the reporting capabilities to meet our compliance, study and patient tracking, enrollment metrics, and financial requirements.”

The ability for the CTMS to integrate with an existing electronic medical record (EMR) system was also a priority for Tampa General Hospital, so users could have easy access to study patients from a centralized database used throughout the hospital.

“Another important factor in our decision was Merge’s vast systems integration experience,” continued Kohl. “A key component of this project will be an HL7 integration, allowing us to feed data from our Epic EMR into Merge CTMS. Through enhanced patient study searches and the elimination of duplicate data entry, this integration will yield significant efficiency improvement for research operations.”

“As an existing Merge Cardio™ and Hemo™ client, Tampa General Hospital was excited to expand their partnership with Merge. Tampa General Hospital expressed specific needs in looking for a CTMS system to consolidate and streamline their clinical trial management and research operations throughout the organization,” said Justin Dearborn, President of Merge Healthcare. “We’re pleased that Merge CTMS provides the opportunity to meet these needs using a highly intuitive interface for a wide variety of users who will access the application on a daily basis.”

Through enhanced productivity and business management tools, Merge CTMS for Investigators allows research organizations to centralize study information, organize research activities, and improve recruitment and financial performance. Merge CTMS scales easily from one to many sites, offering a comprehensive suite of CTMS tools for independent research sites, physician networks, SMOs, hospitals, health systems and academic medical centers.

About Merge Healthcare

Merge is a leading provider of clinical systems and innovations that seek to transform healthcare. Merge’s enterprise and cloud-based solutions for image intensive specialties provide access to any image, anywhere, any time. Merge also provides health stations, clinical trials software and other health data and analytics solutions that engage consumers in their personal health. With solutions that are used by providers and consumers and include more than 20 years of innovation, Merge is helping to reduce costs and improve the quality of healthcare worldwide. For more information, visit merge.com.

About Tampa General Hospital

Tampa General is a private not-for-profit hospital and one of the most comprehensive medical facilities in West Central Florida serving a dozen counties with a population in excess of 4 million. As one of the largest hospitals in Florida, Tampa General is licensed for 1,018 beds, and with approximately 6,600 employees, is one of the region’s largest employers. For more information, visit tgh.org

Cautionary Notice Regarding Forward-Looking Statements

The matters discussed in this news release may include forward-looking statements, which could involve a number of risks and uncertainties. When used in this press release, the words “will,” “believes,” “intends,” “anticipates,” “expects” and similar expressions are intended to identify forward-looking statements. Actual results could differ materially from those expressed in, or implied by, such forward-looking statements. Except as expressly required by the federal securities laws, the Company undertakes no obligation to update such factors or to publicly announce the results of any of the forward-looking statements.

SIRO Clinpharm Selects Oracle Health Sciences InForm to Increase Clinical Trial Productivity and Support Global Electronic Data Capture

Latest Win Strengthens Oracle Health Sciences’ Momentum Across Asia

Redwood Shores, Calif. – Jan. 8, 2013

News Facts

To more efficiently conduct and manage electronic data capture (EDC)-based clinical trials on behalf of its clients, SIRO Clinpharm, winner of Frost & Sullivan Indian Clinical Research Organization (CRO) of the year award, 2012 and 2011, recently selected Oracle Health Sciences InForm.
SIRO Clinpharm’s purchase of Oracle Health Sciences InForm extends the company’s investment in Oracle Health Sciences clinical applications, on which it has built its rapidly expanding CRO business.
In addition to selecting Oracle Health Sciences InForm, SIRO Clinpharm gained a competitive advantage by joining the Oracle CRO Advantage Program – a program that provides a framework for driving CRO success with Oracle Health Sciences products through training, sales and marketing support and tools, and regular communications on Oracle products and strategy.
With its sophisticated data review capabilities, Oracle Health Sciences InForm will enable SIRO Clinpharm to have better control over its data, and the company expects to see significant efficiency and productivity gains in data management and remote monitoring.
Oracle Health Sciences InForm will also provide SIRO Clinpharm flexibility to set targeted source verification strategies that allow for rapid increases or decreases of the source verification workload based on data quality.
Extensive study templates and library management capabilities within Oracle Health Sciences InForm will enable SIRO Clinpharm to accelerate the study-build process and provide sponsors with significantly faster trial implementation.
SIRO Clinpharm will benefit from Oracle Health Sciences InForm’s scalability, performance and multi-language capabilities to deploy global trials.
Oracle Health Sciences InForm is part of a comprehensive portfolio of Oracle Health Sciences Cloud Applications and is powered by the Oracle Health Sciences Cloud to help customers accelerate IT deployments, reduce resources required to maintain IT infrastructure and gain a more predictable IT spending pattern.
SIRO Clinpharm has built a state-of-the-art technology offering that includes Oracle Health Sciences InForm, Oracle Clinical, Oracle Remote Data Capture, Oracle’s Siebel Clinical Trial Management System and Oracle Adverse Event Reporting System.

Supporting Quotes

“As a leading clinical research organization, we looked at the best in class EDC solutions available on the market.  We selected Oracle Health Sciences InForm because we believe it clearly stands out from its competitors with outstanding functionality, low total cost of ownership and satisfied end users worldwide,” said Gopa Menon, chief executive officer, SIRO Clinpharm.
“SIRO Clinpharm has a long-standing commitment to Oracle Health Sciences clinical applications,” said Neil de Crescenzo, senior vice president and general manager, Oracle Health Sciences. “The addition of Oracle Health Sciences InForm will extend SIRO Clinpharm’s clinical data management and EDC capabilities to support a growing number of trials, including global EDC studies, while optimizing its existing Oracle Health Sciences investment.”

About Oracle

Oracle engineers hardware and software to work together in the cloud and in your data center.  For more information about Oracle (NASDAQ:ORCL), visit www.oracle.com.

About Oracle in Industries

Oracle industry solutions leverage the company’s best-in-class portfolio of products to address complex business processes relevant to health sciences, helping speed time to market, reduce costs, and gain a competitive edge.

About SIRO Clinpharm

SIRO Clinpharm, winner of the 2012 & 2011 Frost & Sullivan Indian Clinical Research Organization of the year award, is a drug development solutions provider to the global healthcare industry. Our subject expertise gives us an edge in data management, medical writing, biostatistics & clinical trial management. With a successful track record of 16 years, SIRO Clinpharm works with most of the top global biopharma & medical device companies. Our therapeutic experience includes but is not limited to oncology, diabetes, cardiology, infectious diseases & respiratory system. We offer flexible business models across service verticals based on client needs.

Trademarks

Oracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks of their respective owners.

Link to original press release: http://www.oracle.com/us/corporate/press/1892279

New Tool in Allegro CTMS@Site Allows for Easy Tracking of Patient Recruitment Initiatives

Official press release:

The fall release of Allegro CTMS@Site, the clinical trial management system (CTMS) built for investigator sites and research groups, is rich with new features that aim to ease the workload of busy site staff. One key enhancement, much-anticipated by prospects and customers alike, is the addition of patient recruitment campaign functionality.

Sites are faced with many options for patient recruitment. Ads may be placed on media outlets such as TV and radio, social media may be utilized, or sites may develop their own call or email lists. However, tracking the impact of the campaign, response rate, and actual enrollment from all these sources can be difficult. Even more challenging, is comparing those numbers to the total cost of the recruitment effort and understanding which recruitment methods generate the highest return on investment (ROI).

The new recruitment campaign functionality within Allegro CTMS@Site helps ensure that the appropriate level of contact has been made and the next steps are clearly defined. Site staff can clearly see the recruitment progression from initial contact with a patient through registering them to the protocol.

In addition to traditional recruitment sources, Allegro CTMS@Site allows sites to leverage their existing patient registry to quickly and easily generate their own call or email lists for recruitment campaigns. Within the patient registry, potential matches can be identified on a number of factors that are best suited to the requirements of the protocol. By relying on their existing data, sites can spend their time reaching out to potential patients rather than gathering contact information.

With the addition of patient recruitment campaigns to the already highly adept CTMS, sites are able to streamline and simplify their workflows, increase efficiency, learn from their successes and failures, and ultimately increase their ROI. With a clear understanding of the number of potential subjects contacted versus the number enrolled on the trial and the resources spent, sites gain more visibility into negotiating future recruitment budgets.

Sanofi Selects BioClinicas OnPoint as Enterprise CTMS

Official press release:

– Global Healthcare Leader Becomes the Latest Pharmaceutical Company to Choose BioClinica’s Industry-Leading Clinical Trial Management System –

September 24, 2012. NEWTOWN, PA – BioClinica®, Inc., (NASDAQ: BIOC), a global provider of clinical trial management services, announced today that Sanofi (EURONEXT: SAN and NYSE: SNY), one of the world’s largest pharmaceutical companies, has selected BioClinica’s OnPoint as the company’s standard CTMS (Clinical Trial Management System). With this decision, Sanofi plans to utilize OnPoint CTMS for all clinical trial management activity.

Sanofi is the largest in a growing list of companies that includes other top ten pharmaceutical and medical device manufacturers to embrace BioClinica’s innovative clinical trial management system, making OnPoint the leading CTMS solution for forward-thinking companies.

“BioClinica is extremely proud that Sanofi has chosen OnPoint CTMS,” said Mark Weinstein, CEO of BioClinica. “We look forward to helping fulfill the long-term vision of Sanofi through the use of embedded and transformational applications. This is further evidence that our eClinical solutions are not only leading from a technology perspective, but that our people, products and services are some of the best in the industry.”

BioClinica’s OnPoint CTMS improves clinical trial management by helping sponsors easily centralize and share trial data. OnPoint’s unique Office-Smart design will maximize Sanofi’s existing investment in Microsoft technologies by letting users access, update, and report on clinical trial data from within the familiar environment of Microsoft Office and SharePoint. Using SharePoint as a collaborative portal, OnPoint’s web services integration with other trial management products provides an end-to-end trial management solution. This approach lessens the financial impact of trial management, greatly enhances user adoption, and helps avoid the pitfalls of outdated, legacy CTMS products.

“Providing an end-to-end clinical development platform that unifies the best available solutions is an important part of BioClinica’s approach to trial management,” said Peter Benton, President of BioClinica’s eClinical Solutions. “OnPoint’s ability to exchange information across multiple systems, including Sanofi’s choice of eTMF (Electronic Trial Master File), makes OnPoint the best choice for clinical trial management and demonstrates why BioClinica is the innovation leader in eClinical products.”

“I am confident that OnPoint is the right CTMS for Sanofi and will help bring new therapies and treatments to market faster,” continued Mr. Benton. “As part of Sanofi’s extensive evaluation process, we conducted a proof-of-concept implementation which demonstrated how OnPoint met Sanofi’s key business imperatives of collaboration, integration, and architectural openness.”

As a Microsoft Gold partner, BioClinica has long been known for its industry-leading integration with Microsoft technology. BioClinica was recently awarded a Microsoft Life Sciences Innovation Award for creating the OnPoint CTMS “Monitor Visit Report” which makes it easier for clinical site monitors to enter essential study information with or without an internet connection. Andrea McGonigle, national managing director for Life Sciences at Microsoft Corporation, stated, “BioClinica and Sanofi have both recognized the power of the Microsoft Platform and are using these technologies to build the future of how clinical trials will be run. The power of the Microsoft stack allows scalability and flexibility, and puts the information back in the users’ hands. Instead of monolithic database architectures, Sanofi will be empowered to ‘liberate their clinical trial data’ and make faster decisions.”

One CTMS is not enough

ServersIf you have decided to establish a CTMS system in your company you might think about the nessecity of having multiple installations or instances of this system.

More than one CTMS installation? Why that?
Of course you will ever work with one instance of your company’s CTMS to have one data basis to do reporting and get specific data. But there are other demands towards the implementation process of the CTMS that form the need to have more than one installation. Our proposal is to have three to four instances which does not mean that you will need four times the hardware – thanks to virtualization technologies.

Installation No 1: Productive Environment
This installation is the one productive environment. This system is where all your staff works in and enters real data. This system’s database is the source for all reporting.
Typically, this installation runs on the most powerful hardware of all four. Sometimes this system is even driven by a load balancing server to provide even more performance.

Installation No 2: Test Environment
Never stop a running (CTMS) system! Every change, every update, every bugfix has to be checked before it is implemented in the productive system (1) to avoid any problems. Therefore you should implement a dedicated test environment which is a copy of your productive environment.
Since this implementation is not very likely to be used by many users, it might be sufficient to run it on a virtal server.

Installation No 3: Training Environment
Having a technical solution is one part of the story, having your staff trained to use the system in the right manner is the other part. Independently whether you decide to have classical classroom trainings, e-learnings or a blended learning scenario you will have to have a installation of your CTMS which is espescially installed for training demands.
This system has to be well prepared to provide different training scenarios.

Installation No 4: Validation Environment
Most of the CTMS installations are nowadays validated which means that they comply with the regulations of 21 CFR part 11. To pass the necessary validation process it is a must to have a dedicated validation system to seperate the entries being made while working on test scripts from the productive trial data.

Of course it is possible that you have special conditions which make even more installations necessary, but the four mentioned CTMS installations are a well-founded approach for a professional implementation of your Pharma-IT landscape.