Author: Ferdous Al-FaruqueFDA News
PALM SPRINGS, Fla. — Sites used the Oct. 12-14 Site Solutions Summit here to launch a global trade group, saying it will “amplify” their voice in discussions with sponsors, CROs and other clinical research stakeholders.
“Someone told me … if you’re not at the table, you’re on the menu,” said Christine Pierre, president of the Society for Clinical Research Sites (SCRS). “We’re going to be at the table talking.”
One of SCRS’ main goals will be to increase sites’ influence in clinical policy. “Many of the [global] regulatory agencies put out requests for comments on various draft guidance documents, and we want to insure that sites’ voices are represented in these types of documents,” Pierre said.
The group hopes to hire a global law firm by the end of the year to represent it on public policy matters, and has already brought on board Mark Lacy, founder of Benchmark Clinical Research, to co-chair a public policy committee.
Issues SCRS hopes to address include creating efficiencies in clinical trials, decreasing costs, working on site payment terms and shortening the timeline it takes to get products to market.
In addition to advocacy, SCRS will serve as a forum for tackling site concerns, connect members across various sectors of the industry and mentor new sites, Pierre said.
SCRS also plans to launch a quarterly peer-reviewed journal early next year. InSite will focus on articles that deal with “creating efficiencies, establishing best practices, and reinforcing those best practices with operational tips and tools for the clinical research site community,” Pierre said. She hopes the publication will also help other industry stakeholders understand some of the underlying problems sites face.
Pierre will continue as president of RxTrials, a clinical research site and organizer of the Site Solutions Summit, but will devote all of her time to SCRS, she said. RxTrials Chief Operating Officer Adam Chasse will assume Pierre’s responsibilities at the site. SCRS will also organize the Site Solutions Summit, which will become its annual meeting.
Full membership is limited to clinical research sites, but sponsors and CROs can join SCRS as associate members. This will give them access to certain information, such as running queries on previous clinical research data to evaluate sites.
Learn more about SCRS at www.myscrs.org . — Ferdous Al-Faruque
RELEASE: Immediate CONTACT: Denise Davis, Event and Communication Coordinator Society for Clinical Research Sites 410.696.5080 denise.davis@myscrs.org NEW TRADE ORGANIZATION LAUNCHED WITH GOAL OF CREATING A VOICE FOR RESEARCH SITES Industry Veterans Seek To Give Sites An Active Community Ellicott City, MD, October 15, 2012 –The Society for Clinical Research Sites (SCRS) was unveiled during the 7th Annual Site Solutions Summit on October 13, 2012. SCRS was founded in response to the growing need for a trade organization to represent the voice of clinical research sites within the clinical research enterprise. The Society’s mission is to Unify and amplify the voice of the global clinical research site community. Christine Pierre, founder of the Site Solutions Summit, was motivated, along with other experienced research professionals, to provide sites with resources, mentorship, and new ideas through a membership organization dedicated to providing sites both a voice and community. She explains, “Sites have a major role to play in the clinical trials process, and for too long, they have been the silent partner in the research enterprise, but they will no longer be passive participants. Now is the time for sites to become active partners in the dialogues and solutions through the voice of SCRS.” Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, has been supportive of a stronger voice for clinical research sites. “This is a significant advancement for the clinical research community,” Dr. Woodcock said. “Having a voice for clinical research sites will contribute to the development of innovative clinical studies to gain important information more quickly, and, ultimately, to bring promising drugs to patients in need.” With SCRS a reality, the ability to make a positive difference for the clinical research sites and their industry partners can be realized. Pierre describes what SCRS offers to achieve its mission: SCRS will… Establish a trade organization whose member companies’ foster collegiality and appropriate sharing of information and insights. Advocate by vocalizing and disseminating the clinical research sites’ positions on critical issues and educating other stakeholders regarding those positions. Connect by promoting opportunities for the investigative site community to connect and learn from fellow sites and other critical stakeholders. Educate & Mentor sites to ensure success and the continuation of a legacy of excellence. Ultimately, through supporting its mission, SCRS will help improve the development of safe, effective timely treatments for patients. SCRS looks forward to collaborating with other organizations that have shared vision and recognition of the importance of all stakeholders in the discussion about bringing operational excellence to the clinical research enterprise. Recognizing the value of all industry stakeholders, any company involved in clinical research may participate as a member of SCRS. Membership in SCRS is open to individual clinical research sites, site networks, and companies that sponsor or support the work conducted at sites. Accordingly, membership dues are set at a sliding scale with a range of benefits. Visit www.mySCRS.org for more information. The inaugural Leadership Council of SCRS includes: Thomas Apostle, MD Founder & Principal Investigator Apostle Clinical Trials Clare Grace, PhD Senior Director, Site & Patient Recruitment PPD Deena Bernstein Director of Clinical Research Sheridan Clinical Research, Inc. Michael Jones, MBA Senior Director, Regional Clinical Operations Eli Lilly and Company Christophe Berthoux, DVM, MBA Chief Executive Officer SYNEXUS Jeff Rosen, MD Medical Director Clinical Research of South Florida Robert Califf, MD. Director Duke Translational Medicine Institute, Duke University Vice Chancellor for Clinical and Translational Research, Duke University Medical Center William Smith, MD Founder, President & Principal Investigator Volunteer Research Group / New Orleans Center for Clinical Research Steven Geller, MD Medical Director Centennial Medical Group Frank Willis, JD Executive Vice President Lynn Health Science Institute Kenneth Getz, MBA Founder & Chairman, CISCRP Director of Sponsored Research Programs: Tufts Center for the Study of Drug Development # # #
Author: Ann Neuer Ecliniqua.com The recently held annual Site Solutions Summit* was a high energy gathering of 500 clinical trial professionals culminating with a big announcement—the formation of the Society for Clinical Research Sites (SCRS). This new trade association is intended to provide a much-needed collective voice and a community for global investigative sites, which are anxious for a place at the table as the clinical trials industry works to improve operational efficiency. Industry veteran Christine Pierre, founder of the Site Solutions Summit and SCRS President, notes that sites play a major role in the clinical trials process, and “for too long, they have been the silent partner in the research enterprise. But no longer will they be passive participants. Going forward, sites will become active partners in the industry’s dialogues and solutions through the voice of SCRS,” Pierre comments. Ellen Kelso, Goodwyn IRB In one of her presentations at the Summit, she listed the many industry-wide initiatives working to bring meaningful change to this complex industry, yet few have included sites in the discussion. Considering that sites actually conduct the clinical trials on behalf of commercial and non-commercial sponsors, it’s surprising that input from this critical resource has been overlooked for so long. According to Pierre, “SCRS will provide the site’s perspective to these industry groups looking to solve many research related issues, such as protocol complexity, patient safety, and expanding use of technology.” Without a doubt, announcement of SCRS was the meeting’s big attention-grabber. To keep the momentum going, a white paper entitled, Better Payment Terms for Sites: An Industry Imperative, was circulated to all attendees. The white paper, which describes the critical importance of paying sites monthly to facilitate fiscal viability instead of the current practice of paying quarterly, was the first initiative of SCRS. It also reflects one of its goals, which is to educate the industry about site-related issues. To fuel the education process, SCRS will produce scholarly white papers periodically on topics critical to the well being of sites and to clinical trials stakeholders so they can take informed action and change industry practices. Other parts of the SCRS mission include advocacy; creating an opportunity for sites and sponsors to connect; and mentoring of new sites, with an emphasis on operational excellence. Furthermore, SCRS will host the first site database in which enrollment and FDA audit findings will be compiled on all its members. This cross sectional database of site performance should be a valuable asset to the industry. A number of exhibitors at the Site Solutions Summit first heard about the launch of SCRS at the meeting. Zaher El-Assi, General Manager eClinical for Merge Healthcare, a technology provider, was among them and says, “One of the things that came out of the meeting and the announcement about SCRS is that sites that invest the time to learn from others and invest in infrastructure are more successful clinical research sites. SCRS will bring these sites together so they can learn from each other.” Ellen Kelso, Goodwyn IRB El-Assi explains further that his company has a major commitment to the well-being of sites. “Despite the fact that we’ve been selling to CROs and sponsors for 17 years, 90% of our users are the sites. We have a user base of 40,000 to 50,000 individuals at sites across the globe, representing 8,000 unique sites in 81 countries.” Earlier this year, Merge bought StudyManager (renamed Merge CTMS for Investigators), the clinical trial management system, because it was the first product of its kind specifically focused on the site. “In terms of budget, Merge CTMS provides a platform for sites to be more successful financially by helping them identify and recover funds they are owed among many other critical site-related processes.” Another exhibitor, Ellen Kelso, CEO of Goodwyn IRB, also learned about SCRS at the Summit. “I see the work of SCRS as establishing a dialogue where one has been sorely needed. From an IRB perspective, in order for the ethos of the clinical research community to be complete, you need a voice from every component, and previously this was a missing component With SRCS, sites will get a voice and will be able to be partners in the process,” says Kelso. According to Kelso, Goodwyn IRB, the first all electronic IRB, works routinely and collaboratively with sites and sees her company’s role as instigating best practices and helping sites improve their output. “We walk hand-in-hand with sites and help them learn to operate cleanly, efficiently, and ‘compliantly’. Sites want to do good work, and we help them achieve that, and that sense of achievement is its own motivator.” Kelso adds. The 2013 Site Solutions Summit will take place on Amelia Island, Florida next mid-October.
