Contact:mary.drozario@myscrs.org
FOR IMMEDIATE RELEASE
SCRS Announces Site Scholarships Sponsored by Total Clinical Trial Management
Ellicott City, MD, August 22, 2016 – SCRS announces Site Scholarships sponsored by Total Clinical Trial Management (TCTM). TCTM recognizes the pivotal role SCRS provides in enhancing site success and ensuring their sustainability. These site scholarships will be awarded to site partners identified by TCTM that are not already members of SCRS.
“SCRS has reached over 3,000 research sites and welcomes this opportunity to support more sites in achieving their fullest potential,” said Christine Pierre, President of SCRS. “TCTM has taken a position of being site-centric and by providing these scholarships they are continuing to demonstrate their commitment to being a strong site partner.”
“TCTM is an enthusiastic supporter of SCRS and their mission, and we believe the clinical research ecosystem will be enhanced by enabling the involvement and supporting the membership of more research sites in SCRS,” commented Tim Evans, Vice President, Business Development at TCTM.
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About Total Clinical Trial Managementtotalcro.com .
Contact: Mary D’Rozario Director of Communication Society for Clinical Research Sites 919.890.5513 mary.drozario@myscrs.org FOR IMMEDIATE RELEASE inVentiv Health Expands Partnership with Society for Clinical Research Sites Ellicott City, MD, August 3, 2016 – The Society for Clinical Research Sites (SCRS), the global trade organization fully dedicated to representing the interests of clinical research sites, today announced an expanded relationship with inVentiv Health, a global professional services organization designed to help the biopharmaceutical industry accelerate the delivery of much-needed therapies to market. As a Site Engagement Partner, inVentiv Health will continue to participate on the SCRS Global Impact Board, which works closely with SCRS’ Leadership Council to provide advice on strategic initiatives for SCRS. In addition, inVentiv Health will host two Site Advocacy Groups (SAGs) to gain access to the expertise and insights of SCRS members who have deep knowledge of operational and clinical hurdles that can impact trial conduct. “Investigational sites play an essential role in conducting successful clinical trials,” said Susan Stansfield, PhD, Executive Vice President, Clinical Division, inVentiv Health. “Through this expanded partnership, we will work together with sites to design enhanced processes and procedures to accelerate clinical trial effectiveness.” “inVentiv Health’s increased commitment to site collaboration with SCRS as a Site Engagement Partner is even more exciting because of their involvement through two SAGs,” said Christine Pierre, President of SCRS. “Continued growth in the SAG program and other multi-stakeholders programs affirms that inVentiv Health see SCRS’ commitment to site sustainability as essential to their own sustainability.” ### About SCRS SCRS is a global trade organization founded in 2012 which represents over 2,800 research sites in 42 countries. SCRS’ mission is to unify the voice of the global clinical research site community for greater site sustainability. SCRS has become an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Sites and the companies that sponsor or support the work conducted at clinical research sites will benefit from membership and partnership. Visit myscrs-new.local/. About inVentiv Health inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry accelerate the delivery of much-needed therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) offer a differentiated suite of services, processes and integrated solutions that improve client performance. With more than 15,000 employees and the ability to support clients in more than 90 countries, our global scale and deep therapeutic expertise enable inVentiv to help clients successfully navigate an increasingly complex environment. For more information, visit inVentivHealth.com.
Contact: Mary D’Rozario Director of Communication Society for Clinical Research Sites 919.890.5513 mary.drozario@myscrs.org FOR IMMEDIATE RELEASE SCRS Represents Sites at CDISC Strategy Session Ellicott City, MD, August 24, 2016 – On 02 August Diana Foster, Vice President of Strategy and Development at SCRS, represented the sites at a CDISC Strategy Session moderated by Robert Califf, MD, Commissioner, FDA. The subject of the strategy session was “The Future of Medical Research and the Role of Standards.” Below are selected portions of Ms. Foster’s statement: Lack of standardization is a direct cause of investigator turnover. This contributes to the escalating cost of conducting clinical trials, but this is just one of the costs. It also narrows the physician investigators available to patients. As we look at a variety of care limitations, from limitations in rural care to limitations in diversity, this narrowing adversely affects patients. For example, currently less than 2% of physician investigators are African American. Efficiently bringing new investigators into research is required to change numbers like this. The reality is the “one-and-done investigator” problem continues to plague our industry. Over the past decade as many as 40% of Investigators do only one clinical trial and never conduct another industry sponsored clinical trial. SCRS welcome the opportunity to collaborate with the FDA and other organizations to find ways in which standardization can decrease the burden being placed on sites and allow us to ensure patients have the opportunity to participate in clinical trials. … To ensure study execution with quality and efficiency a clinical site needs an Investigator with a solid clinical research knowledge coupled with an equally profound understanding of the operational necessities in running a clinical research site. Neither of these can be achieved if we continue to experience Investigator turnover at current levels. It is imperative we resolve the burden being posed to sites, which continues to escalate exponentially as protocols and technology demand more of sites. Currently the norm for a site is much like “ground hog day” with each new study they execute, sometimes even when it’s from the same sponsor, is a new experience. During a recent panel discussion where our President, Christine Pierre shared the stage with Dr. Eileen Navarro, Lead Medical Officer for the Office of Computational Science at the FDA, it became obvious that what Dr. Navarro shared would aide her department was quite similar to what sites would request. For instance, protocols designed in a standardized fashion with consistent definitions of terminology would aid anyone working with that protocol to easily locate critical information, which would also reduce non-compliance issues identified by the FDA during site inspections. Through recent work conducted by SCRS we identified that sites may have to use as many as seven different vendors and systems when conducting one study. These systems are typically independent of each other and standardization between them is nonexistent. This fragmentation creates inefficiencies and cost our sites time, which—to repeat—is one of the main reasons they no longer pursue being an Investigator. We applaud TransCelerate’s effort related to the Common Protocol Template initiative and are further encouraged regarding the CDISC’s collaboration on this initiative in helping to provide standardization within the CPT. As sites are often the end user of products and processes that industry implements, we would also like to acknowledge TransCelerate’s decision to include an SCRS Site Advocacy Group in the Common Protocol Template initiative to ensure the sites’ voice is considered as this project unfolds. We want to challenge everyone to take a look at current industry norms –each company with their own and specific protocol designs, training logs, screening logs, adverse event forms, terminology definitions, etc. – and request that anything that can be standardized must be standardized. These are not the areas where companies compete – that occurs at the molecular/device level. Training new site personnel should not involve, “On this study from this sponsor this is the way we do it,” but rather “When we do research, this is what we do.” Not only would a standardized process increase compliance at the site level, it will also allow us more time to spend with the patients and focus in getting the study completed more quickly so the new therapies can get to all patients faster. Thank you. ### About SCRS SCRS is a global trade organization founded in 2012 which represents over 3,000 research sites in 49 countries. SCRS’ mission is to unify the voice of the global clinical research site community for greater site sustainability. SCRS has become an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Sites and the companies that sponsor or support the work conducted at clinical research sites will benefit from membership and partnership. Visit myscrs-new.local/.
