News

September 16, 2011


PharmaPros & OmniComm Systems Announce Partnership Agreement

Dataflow Manager™ integrated via OmniConnect™ API to deliver real-time trial intelligence

Cambridge, MA – Sept 12, 2011 - - PharmaPros Corporation, a technology solutions provider specializing in business intelligence for clinical trials announced today, that OmniComm Systems, one of the fastest growing companies in the EDC marketplace has entered into a strategic partnership agreement to offer PharmaPros’ Dataflow Manager™ as a bundled solution with their flagship EDC product, TrialMaster®.   

The combined solution offers capabilities for electronic data capture (EDC) with integrated, in-stream trial management and reporting capabilities. With integration and interoperability through a web services based application programming interface (API), other technologies, such as IVR and ePRO can easily be plugged into the solution as needed.

Dataflow Manager is pre-configured as an integrated add-on to OmniComm’s products, and serves as a cloud-based operational interface to provide next generation trial management capabilities and unparalleled data visibility at a program, study, site, subject, visit, and form field levels.

“PharmaPros is extremely pleased to be able to offer Dataflow Manager capabilities through our technology partners’ applications. OmniComm shares our philosophy of providing technology agnostic solutions and has proven to be a great partner in providing innovative solutions to our respective customers,” said Brion Regan, Head of Strategic Development at PharmaPros. “

OmniComm was the first organization to become an official member of PharmaPros Adapt technology partnership program. The Adapt program enables 3rd party eClinical technologies to be preconfigured for use with Dataflow Manager using cloud-computing technology.   The companies have collaborated for more than 3 years, and have successfully deployed this integrated solution on more than 8 trials through multiple customer engagements. With this new partnership, OmniComm will now be able to include Dataflow Manager as a part of their eClinical suite of products and sell the solution independently. 

“OmniComm is delighted to have forged this partnership with PharmaPros.  Our customers will reap the benefits of this cutting-edge integration of technologies,” said Stephen Johnson, President & COO at OmniComm.  “The convergence of electronic data capture (EDC) solutions like our TrialMaster with business intelligence tools like Dataflow Manager, will significantly reduce the burden put on our customers to improve clinical trial efficiency while reducing costs.”

About PharmaPros

PharmaPros is a technology solutions provider specializing in data and workflow management for clinical trials. The company’s innovative approach and deep industry expertise have resulted in innovative solutions that are redefining clinical trials technology. PharmaPros is a leader in the emerging generation of cloud-based solutions for clinical trials. The company was formed in 1996, and is located in Cambridge, MA.

About OmniComm

OmniComm Systems, Inc. (www.OmniComm.com) provides customer-driven Internet solutions to pharmaceutical, biotechnology, research and medical device organizations that conduct life changing clinical trial research. OmniComm's growing base of satisfied customers is a direct result of the company's commitment to deliver products and services that ensure ease of use, faster study build, ease of integration and better performance. OmniComm's pricing model is easily understood and allows companies ranging from small, to large, to maximize their clinical research investments. OmniComm Systems, Inc. has U.S. headquarters in Fort Lauderdale, FL and European headquarters in Bonn, Germany, with satellite offices in New Jersey and the United Kingdom, as well as sales offices throughout the U.S. and Europe.

August 30, 2011


PharmaPros’ Selected As Finalist for 2011 SCDM Annual Data-Driven Innovation Award

Submission case study in collaboration with Biogen Idec for the delivery of DFM Enterprise solution

Cambridge, MA – September 30, 2011 - PharmaPros Corporation, a technology solutions provider, announced today that its DFM Enterprise solution has been selected as a finalist for this year’s Annual Data-Driven Innovation Award from the Society for Clinical Data Management (SCDM). The award recognizes the year’s best advancement in clinical data management and innovation that improves technology or processes within clinical research studies. The award will be presented at SCDM’s annual conference, taking place September 11-14, 2011 in Baltimore, MD. 

This year’s entry is in conjunction with customer Biogen Idec, and the successful implementation of PharmaPros’ DFM Enterprise solution on several in-progress, late phase global clinical trials with multiple service providers across 300 sites, in 30 countries, and more than 5,000 patients. Biogen Idec was faced with the challenge of evaluating the status of the data for these trials across disparate systems and multiple service providers.  The magnitude of the challenge was heightened by the global nature of the trials.  Missing data was uncertain and accurate projections of time lines and data was very difficult to evaluate across the global vendor teams. 

A solution that combines PharmaPros’ Enterprise Adapter and Dataflow Manager products, DFM Enterprise created an operational eClinical cloud using Biogen Idec systems, and enabled the company to gain greater visibility across millions of records of data flowing in from EDC, CDMS, CTMS, and multiple IVR and Laboratory systems. Because many of these systems reside behind Biogen Idec’s enterprise firewall, the Enterprise Adapter was implemented to enable delivery of these data to Dataflow Manager via web-services.

With Dataflow Manager providing a near real-time view of expected data at the study, site, subject, visit, and form level, Biogen Idec was empowered with the necessary business intelligence to quickly identify bottlenecks and collaborate with their global CRO partners to successfully manage these studies to a targeted time line. 

PharmaPros was the winner of the 2010 Annual Data-Driven Innovation Award, along with customer Paradigm Spine, and its use of Dataflow Manager to support a Bayesian clinical trial, enabling Paradigm Spine and its service providers to reach PMA submission two years ahead of schedule.

To learn more, visit PharmaPros at Booth 414 at this year’s SCDM Annual conference (http://www.scdm.org/events/fall2011/)

to read PharmaPros' award submission click here >>

July 25, 2011


PharmaPros and Soltex Consulting Partner to Deliver Optimized eClinical Solutions

Partnership to focus on leveraging in-stream data to drive business process optimization

Cambridge, MA – July 25th, 2011 - PharmaPros Corporation, a technology solutions provider specializing in data and workflow management for clinical trials, and Soltex Consulting, a firm that focuses on the integration of people, processes and technology, announced today that they have entered into a strategic partnership agreement.

With Soltex Consulting’s expertise in eClinical technologies and optimized business processes and PharmaPros’ focus on delivering Software as a Service (SaaS) solutions that optimize workflow, the companies have agreed to combine their respective offerings to deliver strategic eClinical solutions that utilize best-of-breed technologies to optimize best practices, and drive efficiencies through the clinical trial lifecycle.

Having recently transitioned the company from a services and technology model into a pure SaaS model, PharmaPros says its strategy is to integrate the expertise of its partners to deliver value-added services. “We see tremendous value in being able to offer our customers the breadth of knowledge and expertise that Soltex can provide,” said Brion Regan, Head of Strategic Development at PharmaPros. “With each company focused on our domain expertise, we are able to deliver eClinical solutions that combine new and existing technologies, optimize business processes, and ensure successful implementation strategies.”

Soltex Consulting co-founder, Christie Mahoney, said “We are excited to be partnering with a true innovator in this industry. PharmaPros’ cutting-edge technology coupled with Soltex’s process optimization and change management offerings will deliver maximum value to our clients." Soltex Consulting seeks to partner with leading technology providers to drive the best possible outcome for companies seeking new efficiencies in their clinical trial workflows.

About PharmaPros

PharmaPros is a technology solutions provider specializing in data and workflow management for clinical trials. The company’s innovative approach and deep industry expertise have resulted in innovative solutions that are redefining clinical trials technology. PharmaPros is a leader in the emerging generation of cloud-based solutions for clinical trials. The company was formed in 1996, and is located in Cambridge, MA.  

About Soltex Consulting

Soltex Consulting is a privately held, independent consulting firm that advises our clients on driving efficiencies throughout the clinical trial lifecycle. Soltex employs an innovative framework to analyze business problems-examining them through the lens of People, Processes and Technology. We then recommend value-driven strategies and implement solutions to tackle our clients’ most critical issues. The company is based in Princeton, NJ and operates globally.

June 06, 2011


Leading Biotechnology Company Selects Dataflow Manager for Multi-Study Program

PharmaPros to leverage OmniConnect API for Rapid Deployment of Integrated Solution

CAMBRIDGE, MA--(Marketwire - Jun 6, 2011) - PharmaPros Corporation, a technology solutions provider specializing in data and workflow management for clinical trials, today announced that a leading biotechnology company has selected Dataflow Manager for a clinical program that includes both early and late phase clinical trials.

Dataflow Manager, a next-generation study management technology, will provide an operational interface to manage trial operations across multiple eClinical technologies, which includes OmniComm Systems' TrialMaster® EDC product. The system will leverage OmniComm's OmniConnect API for in-stream data sharing, and real-time updates. In addition, the CRO responsible for clinical operations will be using Dataflow Manager alongside the sponsor team.

"We are pleased this progressive company has selected Dataflow Manager as part of an integrated solution -- one that will provide in-stream visibility and seamless sharing of key operational data," said Brion Regan, Head of Strategic Development at PharmaPros. "We're pleased to see sponsors leveraging best-of-breed technologies to create eClinical solutions that meet the specific needs of their organizations."

With Dataflow Manager, study teams will be able to track study progress, utilize analytics to predict future milestones, and report on metrics across the entire program. From clinical operations to data management, study teams will have access to dynamic operational information to support in-stream decisions.

OmniComm is a member of PharmaPros' Adapt™ partner program, which was designed to interface any eClinical technology with Dataflow Manager. Partner technologies are available as part of PharmaPros' DFM OnDemand solution, which enables the rapid deployment of integrated eClinical solutions on a per trial basis.

About PharmaPros
PharmaPros Corporation is a technology solutions provider specializing in data and workflow management for clinical trials. The company's innovative approach and deep industry expertise, has resulted in a portfolio solutions that are redefining clinical trials management. The company's leading product -- Dataflow Manager™ -- provides the ability to manage clinical trials using the most accurate and up-to-date information available, enabling trial managers to make more rapid, and better-informed decisions during a trial. PharmaPros was formed in 1996, with headquarters in Cambridge, MA.

March 22, 2011


PharmaPros Wins 2011 Kinetic Process Innovation Award for Paradigm Spine’s application of Dataflow Manager

Cambridge – March 22, 2011- PharmaPros Corporation today announces that it has received the 2011 Kinetic Process Innovation Award for excellence in the Clinical Trials Management category.  Now in its 14th year, the awards program recognizes excellence in information technology and this year is sponsored by High Tech Views, an online publication that spotlights technology innovation.

For Paradigm Spine, Dataflow Manager provided an integrated view of study data across disparate sources, including labs and images, and additional workflows such as reimbursement metrics and CEC adjudication. Dataflow Manager enabled a global workflow that all functional groups in the study collaborated around, allowing them to proactively and holistically process data, address bottlenecks, and ensure Paradigm Spine’s critical Interim Analysis was met on-time.

“PharmaPros Dataflow Manager aggregated clinical trial data for Paradigm Spine, which helped them both cut study timelines and meet aggressive deadlines.  This was truly a vendor/customer partnership that embraced creativity and innovation,” said Drew Barrows, deputy editor of High Tech Views.   “Each year we are amazed to see the wide range of creativity and innovation that are involved in both the technologies and the customer implementations.  This year’s entries, in a variety of categories, exemplified both best practices and creative use of technologies.”

“We are delighted to gain this recognition and receive this award.  We believe Dataflow Manager is unique in the industry and significantly impacts clinical trials management by using  data-driven intelligence to enable the automation of best practices, and empower study team collaboration,“ said Nick Neri, PharmaPros’ Vice President of Technology.

This year’s entries, in a variety of categories, exemplified best practices and creative use of technologies.

About PharmaPros

PharmaPros Corporation is a technology solutions provider specializing in data and workflow management for clinical trials. The company’s innovative approach and deep industry expertise have resulted in products that reflect the company’s core mission of leveraging cutting edge technology to deliver operational intelligence for clinical trials. Its premiere product - Dataflow Manager™ is the industry’s first technology agnostic study management solution.

 

About Kinetic Process Innovation Awards:

The awards program was founded by Kinetic Information LLC in 1996 and is sponsored by various technology publications.  The 2011 awards, sponsored by High Tech Views, recognize innovation in the application of information technology. Awards focus on the business benefits user organizations derive from their technology systems. Winners are selected by a panel of experts consisting of independent professional consultants who are recognized authorities in their fields. The judging process is free of any vendor or other bias so the emphasis remains on the business benefits provided by each winning implementation.

March 11, 2011


PharmaPros Announces Licensing Agreement with Biogen Idec for Dataflow Manager™

License Includes Unlimited Users & Studies for 3 Years

Cambridge, MA – March 7, 2011 - PharmaPros Corporation, a technology solutions provider specializing in data and workflow management for clinical trials, today announced that Biogen Idec, a leading biotechnology company, has signed a three year enterprise license for PharmaPros’ automated study management solution, Dataflow Manager. The deal includes unlimited studies, and unlimited users for the duration of the license.

Biogen Idec’s initial implementation of Dataflow Manager consisted of four (4) in-progress Phase III clinical trials that spanned 36 countries, with more than 5000 patients and 300 sites, using outsourced service providers for global monitoring and data management. Dataflow Manager provided immediate visibility into the progress of the on-going studies, delivering real-time analytics on very large data sets including more than 300,000 forms per study, and one million lab records.

PharmaPros’ proprietary Enterprise Adapter™, a universal web-services adapter, was deployed to enable web services integration with in-house eClinical sources such as Oracle Clinical™ CDMS and RDC, TrialManager™ CTMS, ISI CRFTrack, ALMAC/UBC IVR and central/specialty labs. Automated data loading is also used for information coming from outsourced service providers, such as monitoring logs, and independent safety reporting.

"This is an exciting opportunity for PharmaPros, and our product. The initial implementation with Biogen Idec allowed us to test and prove that Dataflow Manager can scale to large, complex clinical trials with very challenging study management criteria, and that both our cloud computing and SaaS delivery model work for clinical trials of any size” said Nick Neri, Vice President of Technology at PharmaPros.

Recently awarded the Society for Clinical Data Management’s Data Driven Innovation Award, and the Kinetic Process Innovation Award, Dataflow Manager is being recognized as the first commercially available product of its kind in the life sciences industry.

About PharmaPros

PharmaPros Corporation is a technology solutions provider specializing in data and workflow management for clinical trials. The company’s innovative approach and deep industry expertise, has resulted in a portfolio solutions that are redefining clinical trials management. The company’s leading product – Dataflow Manager™ - provides the ability to manage clinical trials using the most accurate and up-to-date information available, enabling trial managers to make more rapid, and better-informed decisions during a trial. PharmaPros was formed in 1996, with headquarters in Cambridge, MA.

October 29, 2010


PharmaPros’ Dataflow Manager™ Wins SCDM’s Annual Data-Driven Innovation Award

Cambridge, MA – November 1, 2010 - PharmaPros Corporation, a technology solutions provider, announced today that its first-in-class, automated trial management solution for clinical trials, Dataflow Manager, received the Annual Data-Driven Innovation Award from the Society for Clinical Data Management (SCDM) at its annual conference in Minneapolis, MN. The award recognizes the year’s best advancement in clinical data management, and innovation that improves technology or processes within clinical research studies.

With accredited CCDM judges selected from among conference attendees, Dataflow Manager was voted the most innovative solution in managing clinical trial data. “We’ve worked hard over the last few years developing this solution in collaboration with our clients, so we are delighted to gain recognition from our peers. We believe Dataflow Manager is unique in the industry because of its ability to provide an integrated view of the study data. This unique capability enables Dataflow Manager to provide one central interface, and one global study workflow for managing clinical trials. We are encouraged that others recognize its value,“ said Nick Neri, PharmaPros’ Vice President of Technology.

The PharmaPros entry was in partnership with Paradigm Spine, a provider of non-fusion spinal implant solutions that serve to address the unmet clinical needs of spine surgeons and their patients. As a result of FDA approval of an interim Bayesian analysis for PMA, the study timeline was decreased by two years, thereby rapidly increasing the need to have a subset of patient data clean and ready for analysis using aggressive timelines.

Dataflow Manager provided an integrated view of study data across disparate sources such as labs and images, and additional workflows such reimbursement metrics and CEC adjudication. Dataflow Manager enabled a global workflow that all functional groups in the study collaborated around, allowing them proactively address bottlenecks and ensure the critical analysis timeline was met.

“We’re very encouraged to see that these companies are attacking the real problems that we face in the industry and that they are branching out beyond the discipline of data management,” said Charlene Dark, CCDM, Annual Conference co-chair. “The Dataflow Manager product solves the challenge of integrating operational data across all functional groups in order to more effectively manage the study.”

There were 12 entries for the 2010 award, the most in the Innovation Award’s four-year history. Five finalists, selected prior to the Annual Conference, demonstrated their products to a judging panel comprised of Certified Clinical Data Managers to determine a winner. The other finalists were: Fortress Medical Systems, in partnership with NaviGo Research; OmniComm Systems, in partnership with Gilead Sciences; Quintiles, in partnership with Eli Lilly and Company; and Spaulding Clinical, in partnership with Logos Technologies and Mortara Instruments.

July 14, 2010


Medelis Selects PharmaPros’ eClinical OnDemand™ Solution. PharmaPros to provide integrated data and technology services

Cambridge, MA, July 15, 2010 ─ PharmaPros, a technical consulting and solutions provider specializing in data and workflow management for clinical trials, today announced that Medelis, a single-source provider for oncology drug development services, has selected PharmaPros’ recently launched eClinical OnDemand™ solution, a unique Software as a Service (SaaS) subscription model for data and technology management.

With eClinical OnDemand™, PharmaPros acts as an outsourced technology department providing all of the technology implementation, management, and support for an end-to-end eClinical suite, as a managed service accessible by the study, program, or as a functionally outsourced department. With this solution, small to mid-sized organizations gain the advantage of a seasoned technology team and best-in-class clinical technology suite delivered with the added value of Dataflow Manager, PharmaPros’ first-in-class study management solution. With Dataflow Manager as the solution’s central interface, study teams can collaborate on study management operations using real-time data intelligence, across systems, sources, and vendors.

“We are excited to have been selected by Medelis to provide this solution. PharmaPros has a unique domain expertise at the intersection of data and technology. This enables us to not only deliver the highest quality services, but to enable specialty service providers to focus on their core competencies and deliver innovative solutions,” said PharmaPros CEO, Peg Regan.

PharmaPros will provide additional services to support both EDC and paper based studies using their proprietary methodology: electronic Data Lifecycle Management (eDLM) in conjunction with Dataflow Manager. With the advantage of an integrated study workflow and access to in-stream study progress, Medelis and PharmaPros will work seamlessly throughout the trial to ensure the expected data lifecycle, trial milestones, and data availability are managed to expectation.

”We are pleased to have found this unique solution to extend our own service offerings. eClinical OnDemand™ has enabled us meet client requirements for progressive technology, in-stream study status and integrated data extracts on-demand, providing us a competitive advantage we would not have with other, more traditional outsourced solutions,” said Bob Bosserman, CEO of Medelis Inc.

PharmaPros’ eClinical OnDemand™ is the first solution of its kind in the industry. Providing small to midsize companies a fully integrated eClinical technology suite, supported by mission critical services to ensure data is managed and available on a continuum from start-up to analysis. Integrated data from all sources including sites, labs, imaging centers are delivered through PharmaPros study management application Dataflow Manager, providing study teams an unparalleled view of study progress.

About PharmaPros Corporation
PharmaPros Corporation is a technical consulting and solutions provider specializing in data and technology for clinical trials. The company’s innovative approach and deep industry expertise, has resulted in the commercialization of a revolutionary solution that is redefining clinical trials management. The company’s premiere solution – Dataflow Manager™ - provides the ability to manage clinical trials using the most accurate and up-to-date information available, enabling trial sponsors and managers to make more rapid, and better-informed decisions during a trial. PharmaPros was formed in 1996, with headquarters in Cambridge, MA.

June 30, 2010


PharmaPros Launches New Solution: eClinical OnDemand™

PharmaPros, a technical solutions provider focused on the delivery of data & technology workflow to support clinical trials, today announced the launch of eClinical OnDemand™, a targeted new service offering that enables small to midsize companies to leverage an integrated eClinical suite made up of best-in-class technologies through a cost effective subscription model.

Leveraging Phase Forward’s industry leading solutions, InForm GTM™, Clintrial™ CDMS, and Empirica™ Trace, eClinical OnDemand™ includes a preconfigured eClinical suite integrated by PharmaPros’ first-in-class study management solution: Dataflow Manager.

“Working with the small to mid-sized market for many years, we understand the challenges they face in managing today’s complex clinical technology landscape. With this market segment developing some of the most exciting products in biopharma and device research, we believe we can have a positive impact on the these companies by providing them with best-in-class technology through a cost-effective and simplified service model,” said Peg Regan, President & CEO of PharmaPros Corporation.

eClinical OnDemand™ is a technology agnostic, Software as a Service (SaaS) solution that offers clients the option to incorporate other data sources such as central laboratories and imaging centers, as well as 3rd party EDC, ePRO, and IVR technologies. eClinical OnDemand™includes a full range of services to support study level requirements: data base design, validation, documentation, change management, and single-source technical support for the entire eClinical suite.

“We are excited to continue our long standing relationship with PharmaPros. Through eClinical OnDemand™, customers in the small to midsize market will have increased access to Phase Forward products, with the added value of PharmaPros services and technology,” said Scott Dixon, Vice President for Phase Forward.

In addition to technology management services, eClinical OnDemand™ offers support for loading and reconciliation of external data sources as well as integrated data delivery to ensure data from external sources is maintained, available and on schedule to be used with the rest of the trial data. Dataflow Manager’s integrated export is also configured to export data across systems, based upon specified client requirements for analysis.

About PharmaPros Corporation
PharmaPros Corporation is a technical consulting and solutions provider specializing in data and technology for clinical trials. The company’s innovative approach and deep industry expertise, has resulted in the commercialization of a first-in-class solution that is redefining clinical trials management- Dataflow Manager™ provides the ability to manage clinical trials using the most accurate and up-to-date information available, enabling life sciences organizations to make rapid, and better-informed decisions, in the management of clinical trials. The company was formed in 1996, and is headquartered in Cambridge, MA.

About Phase Forward
Phase Forward is a leading provider of integrated data management solutions for clinical trials and drug safety. Phase Forward's products and services have been utilized in over 10,000 clinical trials involving more than 1,000,000 clinical trial study participants at over 300 organizations and regulatory agencies worldwide including: AstraZeneca, Boston Scientific, Dana-Farber Cancer Institute, Eli Lilly, the U.S. Food and Drug Administration, GlaxoSmithKline, Harvard Clinical Research Institute, Merck Serono, Novartis, Novo Nordisk, PAREXEL International, Procter & Gamble, Quintiles, sanofi-aventis, Schering-Plough Research Institute, Servier, SGS, Tibotec and the U.K. Medicines and Healthcare Products Regulatory Agency.

March 22, 2010


Leading Medical Device Company Selects Dataflow Manager™ for Eight Clinical Trials

PharmaPros to deliver Dataflow Manager through new functional outsourcing model for midsize companies

Cambridge, MA, March 22, 2010 ─ PharmaPros, a technical consulting and solutions provider specializing in data and technology management for clinical trials,today announced that an industry leading medical device company focused on alternatives to spinal surgeries, has selected Dataflow Manager, PharmaPros’ automated trial management solution, for eight clinical trials that make up a clinical program for its lead product candidate.

Along with the Dataflow Manager implementation, PharmaPros will provide data lifecycle management services to support the Sponsor in proactively managing its clinical program. PharmaPros recently introduced this delivery model to enable companies with fewer in-house resources to realize the benefits of Dataflow Manager, and the company’s progressive workflow methodology: electronic Data Lifecycle Management (eDLM).

“We are excited to offer Dataflow Manager through this unique functional outsourcing model. An integrated solution of data, workflow, and technology, this model enables companies of all sizes to gain the benefit of a comprehensive eClinical solution without the cost of assembling and managing it on their own. Whether for a clinical program, or a single trial, companies can now benefit from PharmaPros expertise, eDLM methodology, and Dataflow Manager technology through one functional solution,” said PharmaPros CEO, Peg Regan.

Officially launched in 2009, Dataflow Manager is already in use at multiple Pharmaceutical, Biotech and Medical Device organizations, and is being hailed as the next generation in eClinical technology. A first-in-class solution, Dataflow Manager automatically tracks the status of a trial against every data source in the study, (Labs, CRFs, EDC, IVRS, CTMS, ePRO, Images) providing an integrated view of the study data. This unique capability enables Dataflow Manager to provide a central interface, and one global study workflow for managing clinical trials.

About PharmaPros Corporation
PharmaPros Corporation is a technical consulting and solutions provider specializing in data and technology for clinical trials. The company’s innovative approach and deep industry expertise, has resulted in the commercialization of a revolutionary solution that is redefining clinical trials management. The company’s premiere solution – Dataflow Manager™ - provides the ability to manage clinical trials using the most accurate and up-to-date information available, enabling trial sponsors and managers to make more rapid, and better-informed decisions during a trial. PharmaPros was formed in 1996, with headquarters in Cambridge, MA.

Media Contacts:

Brion Regan
PharmaPros
Brion.Regan@PharmaPros.com
www.pharmapros.com

November 02, 2009


FUJIFILM Medical Systems USA Selects PharmaPros Dataflow Manager™ for Multi-Study Collaboration

Cambridge, MA, October 6, 2008 PharmaPros, a technical consulting and solutions provider specializing in data and workflow management for clinical trials, today announces that FUJIFILM Medical Systems USA (Fujifilm), a leading provider of diagnostic imaging products and network systems, has selected the company’s Dataflow Manager™ solution, and study support services to assist with Fujifilm clinical studies. Dataflow Manager is a first-in-class automated trial management solution that provides in-stream access to study status across multiple disparate systems and vendors used to manage today’s complex trials. Dataflow Manager automatically tracks the status of a trial against every data source in the study, (Labs, CRFs, EDC, IVRS, CTMS, ePRO, Images) and acts as a collaboration portal allowing study teams to manage clinical trials with an integrated view of the study data. Fujifilm and PharmaPros have collaborated to develop a new Dataflow Manager module, the Image Acquisition & Tracking System (IATS), which will be leveraged by the study teams to collect image data and track image quality in-stream. Utilizing the extensive data tracking and reporting capabilities of Dataflow Manager, the Fujifilm teams will have in-stream access to the status of their trials. “We’re excited Fujifilm has extended their relationship with PharmaPros and will be utilizing the Dataflow Manager solution,” says Peg Regan, CEO of PharmaPros. “This truly is a collaborative relationship in which both Fujifilm and PharmaPros are committed to new and innovative ways of managing the workflow around clinical trials data.” Dataflow Manager™ will serve as a portal through which the Fujifilm teams can manage these studies collaboratively, leveraging the in-stream visibility to make time-critical decisions and track and report on study related metrics and milestones.

About FUJIFILM Medical Systems USA

As one of the FUJIFILM Corporation family of companies with 70 years of imaging experience and almost $25 billion in sales, FUJIFILM Medical Systems USA, Inc. is a leading provider of diagnostic imaging products and network systems to meet the needs of healthcare facilities today and well into the future. Fujifilm’s family of Imaging Systems products and technologies—including digital x-ray, women’s healthcare imaging, dry imagers, and conventional x-ray film and equipment—are tailored to suit many different applications for a variety of imaging environments. The pioneer in the field, Fujifilm remains the market leader in digital x-ray with products that are clinically proven and constantly evolving to set the standard in digital imaging innovation. FUJIFILM Medical Systems USA is headquartered in Stamford, CT. More information is available at www.fujimed.com.

About PharmaPros Corporation

PharmaPros Corporation is a technical consulting and solutions provider specializing in data and workflow management for clinical trials. Through its proprietary processes and tools, the company provides services to support the entire data lifecycle— enabling sponsor companies to effectively manage complex trials with multiple vendors and systems. PharmaPros was founded in 1996 and is headquartered in Cambridge, Massachusetts.

November 02, 2009


PharmaPros Dataflow Manager™ Selected by Capstone Therapeutics for Phase 2 Study

Dataflow Manager to provide integrated study dashboard for data lifecycle management

Cambridge, MA, March 3, 2009 PharmaPros, a technical solutions provider specializing in data and workflow management for clinical trials, today announced that Capstone Therapeutics has selected the company’s data lifecycle management solution, Dataflow Manager, for its Phase 2 study to evaluate the safety and preliminary efficacy of AZX100 in trocar sites of arthroscopic shoulder surgery patients.

Capstone Therapeutics (trade name of OrthoLogic Corp.) is a biotechnology company committed to developing a pipeline of novel therapeutic peptides aimed at helping patients with under-served medical conditions. “PharmaPros and Capstone share philosophical synergies from our multiple trial engagements,” said Peg Regan, CEO of PharmaPros. “Dataflow Manager, which will be utilized as Capstone’s trial management interface, underscores this joint philosophy: achieving higher quality data through in-stream data access and maintaining control of the data throughout its lifecycle.” During the trial, Capstone and its service providers will utilize Dataflow Manager as its central interface to track and manage clinical information for the Phase 2 study. Using virtual integration, Dataflow Manager will provide an integrated view of study metrics in-stream, including patient data via EDC, safety data, 2D & 3D medical images and image findings data, and laboratory data. Dataflow Manager will also provide Capstone statisticians with on-demand outputs of integrated datasets for in-stream data analysis.

The Dataflow Manager solution for Capstone includes a PharmaPros Data Lifecycle Manager who will collaborate with Capstone throughout the study using Dataflow Manager’s interactive reporting dashboards to track data readiness for interim-analysis, ensure timely entry of data at the investigator sites, manage technology vendors and assist project teams in ensuring critical milestones and timelines are being met.

“We are pleased to be working with PharmaPros and to be using Dataflow Manager,” said Joan Matusin, RN, Senior Director, Clinical Operations, Capstone Therapeutics. ”The program interface allows our company to retain the level of control and visibility necessary to ensure successful execution of our studies.” Dataflow Manager is a first-in-class solution that facilitates in-stream Data Lifecycle Management, the next generation of managing clinical trials data. Using virtual integration and process automation, Dataflow Manager empowers companies to proactively manage clinical trials across multiple data systems and vendors, and against expected milestones and timelines.