Enables secure global document sharing and community management tools for life sciences
McLeansville, N.C. – August 15, 2013 – Litera® announces the acquisition of AxxiTRIALS, a leading Clinical Trials Portal solution providing life science companies and clinical research organizations (CROs) with a platform designed to dramatically speed site start-up, patient recruitment, and end-to-end clinical trial operations.
"This acquisition is in keeping with Litera's continued strategic focus on secure, compliant collaboration and nicely aligns with our content management product portfolio," said Litera President Karen Massand. "We see AxxiTRIALS, with its emphasis on outstanding user interface, community building and engagement tools, together with Litera's powerful document lifecycle, security and collaboration solutions as an absolutely unbeatable combination."
AxxiTRIALS improves operating efficiencies by uniting global trial teams, from Sponsor, CRO and sites, under a single interface that is easy to use, engaging and integrated with existing systems. AxxiTRIALS' customizable workflow tools and compliant document management system speeds the site start-up process, ensures compliance, centralizes key trial information, creates community and keeps investigators and site coordinators engaged throughout the clinical trial.
"Pharmaceutical, medical device, biotech and clinical research organizations that leverage the power of the web see a tremendous acceleration of their trials, particularly in the areas of start-up and patient recruitment, enabling life-saving products to get to market faster," said Susan MH Lewenz, founder of AxxiTRIALS and now VP and General Manager at Litera for the AxxiTRIALS franchise. “Interestingly, the CRO clients who have private-labeled our offering tell us that it has even helped them win new business, as many trial sponsors have now witnessed this speed improvement and demand a portal be used for their projects.”
AxxiTRIALS is used for trials of all sizes in locations all around the world to accelerate document handling from feasibility and site start-up documentation, to ongoing safety alert, training and communications management, through the locking of the trial master file. Like other Litera products, AxxiTRIALS is designed to be so intuitive that it requires little or no training, works on any device anywhere in the world and provides the right content and tools for the business process.
AxxiTRIALS joins a powerful suite offered by Litera, including its Galaxy portal solution for document and matter collaboration across enterprises, as well as solutions for document templates and numbering, content assembly, document comparison, rights management, large/secure file transfer and synchronization, and metadata management.
Litera offers a comprehensive suite of cyber-secure document creation, collaboration, comparison, control and cleaning technology that provides organizations with unsurpassed content confidence; information workers and mobile professionals can manage their documents and data with a degree of control not available through any other applications on the market. Litera’s patented solutions enable more secure and effective collaboration between people, teams and organizations to empower ideas that drive success. Visit www.Litera.com now.
Provides enhanced regulatory document processing for AxxiTRIALS™
Axxiem Web Solutions announced today the release of its Axxivation regulatory document processing module which is now part of the AxxiTRIALS Clinical Trials Community Portal solution. The Axxivation module is designed to manage the site activation process, providing pre-qualified sites with access to a range of startup features as well as training videos on how to navigate through the document approval process.
“High on our list of system enhancements to AxxiTRIALS was the ability to carve out the site startup process from active study site management,” said Susan MH Lewenz, Axxiem CEO. “The Axxivation module allows for focused site-by-site start up management, including a robust document exchange and review system, site specific dashboard communications and calendars. AxxiTRIALS features of Live Chat, and document notes history are also part of Axxivation. Once the sites are activated, these users gain access to the full suite of AxxiTRIALS features including community forums and blogs, enrollment statistics and active trial notices”.
The Axxivation module introduces a site-level dashboard that facilitates direct communications with each pre-qualified study site regarding their startup and regulatory documents, actions required from them, their calendar of upcoming milestones and events, as well as news and announcements regarding the trial. By allowing each study site to have a unique dashboard with information tailored specifically to them, Axxivation helps site users manage their clinical trial workload, boosting their efficiency and expediting the site activation process.
“Study startup functionality and site- specific communications were features we asked Axxiem to develop for the system, and we are delighted to see these come to market. They will save valuable time by reducing document turnaround,” said Dan Diaz, Vice President of Business Development for Beardsworth Consulting Group, a CRO based in Flemington, NJ.
Axxiem will be providing demonstrations of Axxivation and the AxxiTRIALS Clinical Trials Community Portal during the BIO International Convention (Booth 1305) in Boston on June 18th – 21st. AxxiTRIALS was also one of five products selected for inclusion in the DIA Annual Meeting’s Entrepreneurs Pavilion (Booth 1709) in Philadelphia on June 25th-27th.
About Axxiem Web Solutions and AxxiTRIALS:
Based in Irvington, NY, Axxiem Web Solutions has been designing and building custom web solutions for a broad range of pharmaceutical and biotech clients, including Eli Lilly, Regeneron, Aldagen, The Medicines Company, Pfenex and Transparencyls.com. With direct input from existing customers and end users who wanted a system to improve communications between their clinical operations staff and trial sites, Axxiem built the AxxiTRIALS Clinical Trials Community Portal. The result is a web-based, fully customizable global portal, designed to save clinical trial sponsors and CROs time and valuable resources, as well as to engage, motivate and better inform investigators.
A well designed CTCP can keep everyone motivated and focused on achieving trial objectives
Many sponsor and CRO companies are implementing some form of eClinical to improve operating efficiencies by utilizing technology to modernize outdated paper-based processes and to improve data quality. Until recently, the family of eClinical mainly consisted of solutions like EDC, CTMS, IVRS, or some combination thereof. The latest addition to this family, “investigator portals” or “clinical trial community portals,” is set to improve clinical trials on a fundamental level by tackling a critical component of the success of a trial: communication within the trial community.
Clinical trial community portals (CTCPs) emphasize the fact that a clinical trial is run by a community of people with a common goal. To succeed, the group requires specialized tools to facilitate their communications, as well as motivational features to keep everyone engaged and focused.
Document management features of a robust CTCP are the first reason a sponsor or CRO will look to the portal solution, including: the ability to send, receive, and track documents electronically along with automated notifications and reminders; alerts and reminders through e-mail, sms, fax, and on a dashboard; 21 CFR Part 11-compliant electronic signatures; online binder and regdoc management tools for site start up; document tracking and reporting tools; and online training, available 24/7/365.
While the benefits of document management systems may be self-evident, the benefits of additional community features are sometimes less obvious. Whether sponsors and CROs recognize it, they and the members of their clinical study sites are a community, and in the age of social media, its value cannot be overlooked or overstated.
Community features, like private live chat or moderated forums, turn portals into much more than just document management tools; they become hubs of trial-specific knowledge sharing and motivation. Unlike their enterprise-only predecessors, web-based portals are easy, fast, and economical to deploy, making them feasible for virtually any study.
Community features of CTCP’s include: enrollment statistics; forums and blogs; secure private live chat; news and announcements; and calendars.
For sponsors/CROs, engaging the trial community in dialogue throughout the duration of the study, not just during meetings or conference calls, is key for improving trial quality. According to the National Cancer Institute “the role of physicians in recruiting patients to the clinical trial is pivotal.” Investigators and study coordinators have valuable insights that may improve trial quality, but rarely have access to clear, easy channels or the incentive for communicating them.
Seventy percent of healthcare providers surveyed by Frost & Sullivan are using social media to communicate with other professionals. By combining the engaging, community-building features of social media with efficiency-boosting, CTCP offers a way to overcome many of the challenges that the pharma industry faces in operating clinical trials. The CTCP invites and engages the physicians by enabling them to keep their trial on track, taking required action as well as providing valuable insights and opinions wherever they are.
The time saving tools and community features of a good CTCP, when properly designed in a user-friendly fashion, serve a very real and important function of encouraging portal usage, which, by extension, keeps everyone motivated and focused on achieving the trial’s objectives.
AxxiTrials selected as one of six technologies to exhibit at DIA's Entreprenuer Pavilion
With its theme of “Collaborate to Innovate,” DIA 2012 is structured to encourage the partnerships needed to translate promising concepts and research into pioneering new patient therapies. DIA will recognize innovative early-stage companies that are impacting the clinical research industry. These companies were provided the opportunity to submit an application detailing how they embodied the characteristics of “Collaboration and Innovation” and how they fostered those characteristics in their offerings. A DIA panel reviewed the applications and selected six entrepreneurial companies that will be given the opportunity to showcase their work at this year’s DIA Annual Meeting.
Axxiem Web Solutions, developers of the AxxiTRIALS Clinical Trial Community Portal, is proud to announce that we have been selected to participate in the DIA 2012 Annual Meeting’s Life Science Entrepreneur Pavilion from June 25-27th at the Pennsylvania Convention Center, Philadelphia, PA. We will be giving demonstrations of the AxxiTRIALS portal to potential customers visiting the Exhibit Hall.
We hope to see you at DIA this year.
Experienced Clinical Trial Experts to Provide Strategic Product Direction
Axxiem is pleased to announce the formation of its Clinical Advisory Board to provide strategic input and direction for the AxxiTRIALS Clinical Trial Community Portal. In addition to internal Axxiem staff members, Axxiem has recruited clinical trial experts to assist us as we continue to develop and enhance the AxxiTRIALS product line. “The addition of these highly experienced individuals to the AxxiTRIALS advisory team will provide us with expert feedback on our product design and functionality, in addition to business savvy based upon their individual achievements in start-up environments,” added Susan M.H. Lewenz, President and CEO of Axxiem. These experts are:
LAURIE HALLORAN, BSN, MS, President and Chief Executive Officer
Halloran Consulting Group
Laurie founded Halloran Consulting Group (http://www.hallorancg.com) in 1998. With over 25 years of experience in clinical affairs management with contract research organizations and biotechnology companies, Laurie is recognized as an industry expert in improving the organizational effectiveness of clinical research programs with a specialty in gap analysis and strategic planning. Prior to founding Halloran Consulting Group, Laurie spent 10 years at PAREXEL International where she developed worldwide training capabilities with the clinical operations group. She has also established clinical operations at OXiGENE and Antigenics.
ALAN BOYD, R.PH., Chief Executive Officer
CNS Vital Signs, Inc.
Alan has been employed in a variety of roles in the pharmaceutical industry over the past 20 years. He has served as a consultant across many facets of the pharmaceutical and CRO industries ranging from marketing to drug development. He has also been a principle member of, as well as an advisor to, several start-up companies and angel funds. Presently, Alan is CEO of CNS Vital Signs (http://www.cnsvs.com), which offers a technical platform utilized to clinically assess neurocognitive pathology and cognitive drug effects.
ANNE V. SHEMER, PH.D., President
Anne Shemer Consulting
Dr. Anne Shemer is a pharmaceutical executive with over 25 years of experience in clinical development and marketing. Her focus includes international clinical trials design and supervision, site selection and training, regulatory interactions, and product launch preparedness. Her clients have included companies such as Merck, Boehringer Ingelheim, Sanofi-Aventis, and Pfizer. She is multi-lingual (French, Spanish, Italian, German, and Hebrew) with a proven track record in US and EU regulatory approvals and new product launches, with specific expertise in multiple therapeutic areas such as psychotropics, stroke, pain, respiratory, gastrointestinal, infectious diseases, and neurodegenerative diseases.
KATE M. DIDIO, MBA, President
KMD Consulting, LLC
Kate Didio has 20 years of pharmaceutical, biotech and CRO experience, including over 8 years as a Director/Senior Director of Clinical Operations in small to mid-sized pharmaceutical and biotechnology companies, including Surface Logix, Inc. and Sepracor, Inc. (now Sunovion). She is currently the Senior Director of Clinical & Regulatory Affairs at Sirtris Pharmaceuticals in Cambridge, MA. Her areas of responsibility have included clinical operations, project management, regulatory operations, clinical quality assurance & risk management, pharmacovigilance, medical writing, outsourcing and data management.
Senior Director, Global Clinical Operations
Shire Human Genetic Therapies
Nancy Wyant is the Senior Director of Global Clinical Operations at Shire Human Genetic Therapies (HGT). She provides professional expertise and strong leadership in strategic program development and operational execution of clinical trials. Nancy has over 18 years of experience in the clinical research industry. Prior to her current position, she served as Director of Clinical Compliance after having started the compliance group at Shire HGT. Besides her work at Shire, Nancy has worked within clinical operations groups at Therion Biologics Corporation and Vertex Pharmaceuticals, as well as at several biopharmaceutical start-up environments.
For additional information regarding the biographies of the Advisory Board members, please visit axxitrials.com/advisoryboard.
CenterWatch Article Discusses the Role of Social Media in Clinical Trials
The latest “hot” topic in clinical trials is how social media is a “must” for patient recruitment. There is little doubt this new public forum holds an important place in patient enrollment and participation.
But what about using similar, albeit private, social media tools with “communities” that already exist internally to clinical trials—those between sponsors/CROs and their sites?
Few sponsors recognize these private communities, let alone garner their benefits. A Clinical Trials Community Portal (CTCP), which plugs in to existing systems through web services, is relatively simple to add. The CTCP’s primary function is improved communication between the sponsor/CRO and sites. The operational benefits, savings and efficiencies come from features including:
The community component of the CTCP also can have a great impact on trials. Private and secure forums, blogs and image galleries can motivate CTCP usage and, by extension, keep sites focused on the objectives.
The investigator’s involvement in the day-to-day operation of a trial can be critical to recruitment success. The CTCP enables the physician to provide insights, opinions and input on his schedule on any device. According to Frost & Sullivan, 70% of healthcare professionals use social media to communicate with other professionals. By using a CTCP, sponsors save sites time and provide motivational tools, including the sharing of ideas and best practices with colleagues in a private, moderated forum.
Sponsors and CROs can harness the power of social networking to change how their own clinical operations teams interact with their sites, facilitating the flow of communication. The key to improving trial quality will be engaging the trial community in dialogue throughout the duration of a study.
Leading CRO selects AxxiTRIALS for its Clinical Trials Investigator Portal solution
AxxiemWebSolutions, a leading provider of digital solutions for the life sciences, today announced that Beardsworth, a full-service contract research organization, has selected its Clinical Trials Portal solution, AxxiTRIALS, for enhanced site communications in support of their "Investigator Express" program.
"This addition of AxxiTRIALSs provides important leverage to our BNet Trial Management System, by offering improved communications to the community of sites participating in a trial" said Michael O’Brien, Beardsworth President & CEO. "We see AxxiTRIALS, with its unique abilities to build a "closed community" among trial sites, to be an innovative solution to one of the biggest challenges facing global trials – timely and efficient communication between Sponsor, CRO and the Investigative Site."
"The enhanced communication pathways will provide our CRAs and Project Managers faster access to the sites and will offer a faster methodology to process Start up regulatory packages. The ability to provide a secured E-signature (CoSign) platform will compress valuable time and expense in the collection and tracking of regulatory documents, alone," states Evette Riegel, RN, Beardsworth Sr. Director Clinical Operations.
AxxiTRIALS will be integrated into Beardsworth’s Investigator Express program and will be a cornerstone of the investigator communication platform.
"We are delighted to be working with Beardsworth and their clients," said Susan MH Lewenz, Axxiem’s President & CEO. "AxxiTRIALS is designed to fill an important need that companies have in improving communications between their trial operations teams and the investigators/coordinators at clinical sites. Our Community Portal empowers users by providing a simple and secure way to efficiently distribute, sign, and track time-sensitive documents. Additionally, training materials, including embedded videos, are "at the ready" for users around the world, with the additional ability to share ideas and best practices via our Forum and Live Chat features. Our goal is to build a sense of community among the trial sponsor and clinical trial coordinators. AxxiTRIALS is also designed to implement quickly and integrate seamlessly with existing systems, like Beardsworth’s "BNet" Clinical Trial Management System."
Beardsworth Consulting Group, Inc. (http://www.beardsworth.com) is a full-service CRO whose service offerings span all stages of drug development and clinical trial management. With a command of the complex trial, Beardsworth’s niche expertise focuses on oncology/supportive care and vaccine therapeutics. Beardsworth brings 25+ years of experience, expertise and commitment to provide clinical trial solutions for results, on time, and within budget.
Headquartered in Flemington, New Jersey, Beardsworth provides global reach that is local in connection. Beardsworth is the founding partner of OncologyOne® – an alliance of top regional CROs providing full service business and research strategies for global oncology trials. Beardsworth is a federal CCR registrant and designated Small Business.
About AxxiemWebSolutions and AxxiTRIALS
For over eight years, Axxiem has been designing and building custom web solutions for a broad range of pharmaceutical and biotech clients, including Eli Lilly, Regeneron, Aldagen, The Medicines Company, Pfenex and Transparencyls.com.
Seizing the opportunity to better serve our customers, Axxiem built AxxiTRIALS with direct input from existing customers and end users who wanted a system to improve communications between their clinical operations staff and trial sites. The result is a web-based, fully customizable global portal, designed to save the clinical trial sponsor time and valuable resources as well as to engage, motivate and better inform investigators. AxxiTRIALS provides a secure and simple way to distribute and track time-sensitive documents and training materials, to share patient recruitment metrics, and to build a sense of a community among sponsor staff, global clinical investigators, and other outside resources involved in the trial.
--New version to debut at Partnerships in Clinical Trials in Orlando March 5-7th--
AxxiemWebSolutions announced today that it will debut AxxiTRIALS 2.0, the latest release of its Clinical Trials Community Portal solution, at the Partnerships for Clinical Trials event in Orlando on March 5-7, 2012.
"Listening to both our customers and their clinical sites, we had the opportunity to enhance several important features of our system," said Susan MH Lewenz, Axxiem CEO. "AxxiTRIALS 2.0 has a simplified, even more engaging dashboard for the site users to get tailored information at a glance. For the portal administrators at the Sponsor or CRO, the dashboards are more robust and easier to manage."
The new dashboard includes enhanced focus on Action Items - documents that must be read or signed - which are featured prominently at the top of the dashboard and are indicated with a hard-to-miss flag that stays up until all action items are addressed. Important alerts about the trial overall or specific to the study site are shown in the scrolling new ticker at the top of the page. "Our customers wanted more channels that could be used to speak to their trial sites" commented Kate Zelenova, AxxiTRIALS Associate Creative Director. "A system is only as good as the adoption experience of the user base. Every design decision we make starts first with this consideration, so we strive to keep the interface intuitive and the page contents flexible."
Building on the community aspects of our investigator portal, AxxiTRIALS aims to keep all trial stakeholders in step with meeting the trial's objectives, such as maximizing enrollment rates. So the AxxiTRIALS 2.0 dashboard features various graphics summarizing day-to-day progress of patient recruitment, such as interactive maps and bar graphs.
"We also made some important improvements to the myBinderTM feature of AxxiTRIALS," added Ms. Lewenz. "Helping users to manage documents in a way that is intuitive and effortless is a real art. In the new design, users don't have to file or categorize anything. If they open and read a document - guess what? - it gets filed in their "Read documents" folder. If they don't, it stays in "Unread". Users just need to act on their documents. AxxiTRIALS will do the rest."
AxxiTRIALS will be providing demonstrations of the enhanced Clinical Trials Portal at their exhibit booth (#200) starting at 5:00 PM on March 5th. We invite attendees to visit and learn about the utility of this product specifically for their clinical trials.
More Info at:
tel: 877-4AXXIEM (877-429-9436)
CenterWatch Article Speaks to Clinical Trials Portals and AxxiTRIALS. CenterWatch recently published an article on the growing use of Clinical Trials Portals:
As sponsors and CROs feel the pressure to improve clinical trial efficiency, increase enrollment and maintain a solid bottom line, it’s critical that they avoid information overload while measuring the right performance indicators as data from multiple sources is streamlined.
That’s the tall - and growing - order of clinical trial portals, now used by study managers, data managers and medical, safety and regulatory staff to help plan, conduct, manage and review trials....
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