Contact:Amanda Ascoli Communications Associate Society for Clinical Research Sites 410.696.5080 x120 amanda.ascoli@myscrs.org
FOR IMMEDIATE RELEASE
Society for Clinical Research Sites Welcomes Clinical Ink as New Global Impact Partner
Ellicott City, M.D., December 9, 2014 – The Society for Clinical Research Sites (SCRS), the global trade organization fully dedicated to representing the interests of clinical research sites, today announced a two-year collaboration with Clinical Ink, the pioneering provider of eSource solutions for clinical trials. Clinical Ink will participate as a Global Impact Partner (GIP) and align with other sponsors, CROs and service providers who share an ongoing commitment to research site success.
“Clinical Ink’s relationship with SCRS illustrates their commitment to strengthening site partnerships and accelerating collaboration amongst industry stakeholders,” comments Christine Pierre, SCRS President. “Working together with this leading organization is a significant strategic development for SCRS, and will add considerable momentum to our Global Impact Partnership program. SCRS is proud to welcome Clinical Ink to our community.”
“This partnership reinforces our commitment to sites and dedication to making clinical research easier for sites, sponsors, subjects and regulators,” said Ed Seguine, CEO, Clinical Ink. “Clinical Ink was co-founded by a clinical investigator who understood the challenges of clinical research from 20+ years of experience. Through new collaborations as an SCRS GIP, we look forward to gaining insights that will help guide the continued evolution of SureSource as a primary tool for sites.”
As a Global Impact Partner (GIP), Clinical Ink will participate on the SCRS Global Impact Board at an executive level, and work closely with SCRS’ Leadership Council to determine strategic initiatives for SCRS.
About SCRS
SCRS is a global trade organization founded in 2012 which represents over 1,750 research sites, including 26,000 research professionals; 15,000 investigators and 9,000 research staff, in 39 countries. SCRS’ mission is to unify the voice of the global clinical research site community for site sustainability. SCRS has become an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Sites, as well as companies that sponsor or support the work conducted at clinical research sites, will benefit from membership and partnership. Visit myscrs-new.local/ .
About Clinical Ink Founded in 2007, Clinical Ink is the pioneering provider of eSource solutions for clinical trials. Developers of SureSource® – the first purpose-built and most widely used eSource platform – Clinical Ink is dedicated to streamlining clinical development from Start to Submit™. Clinical Ink maintains offices in Winston-Salem, NC and Philadelphia, PA. Additional information is available at www.clinicalink.com or toll-free 1-800-301-5033.
Contact: Amanda Ascoli Communications Associate Society for Clinical Research Sites 410.696.5080 x120 amanda.ascoli@myscrs.org FOR IMMEDIATE RELEASE Society for Clinical Research Sites Expands Relationship with INC Research as First Circle of Sustainability Sponsor Ellicott City, M.D., December 4, 2014 – 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 partnership with INC Research Holdings, Inc. (Nasdaq: INCR), a leading, global, Phase I to IV contract research organization as the society’s first Circle of Sustainability Sponsor, further reinforcing the Company’s commitment to fostering strong site relationships globally. Through this enhanced relationship, INC Research will be the first organization to support SCRS’ new member Scholarship Program as well as the first CRO to establish a Site Advocacy Group (SAG). INC Research also will continue as a Global Impact Partner and Site Appreciation Reception sponsor for all SCRS’ Site Solutions Summit events globally across 2015. “Sites are critical to the clinical development process and it is important that we continue to recognize their contributions and provide them with the support they need to be successful,” said Jamie Macdonald, Chief Executive Officer. “INC Research is excited to partner with SCRS on these key initiatives focused on strengthening support to sites globally and leveraging their insights to improve clinical development. Through our participation, INC is afforded additional avenues to actively listen to and engage with site communities across the globe, allowing us to gain valuable perspectives earlier in the clinical trials process that we believe will lead to greater predictability in site performance, improved site sustainability and ultimately faster delivery of new medications to patients.” “As an industry, it’s imperative that we more fully understand and identify high-performing clinical research sites and develop new models to improve site sustainability,” stated Christine Pierre, President, SCRS. “Having INC Research’s continued support for endeavors like our SAG program, which was initiated to catalyze productive dialogue between sites and industry, and our new member Scholarship Program, which grants SCRS membership to 500 non-member sites, is invaluable as we continue to advance the role of sites in clinical research. This membership opportunity will provide educational, business and operational training programs that promote site sustainability and enhance clinical research effectiveness.” As the first sponsor of SCRS’ scholarship program, INC Research will support the society’s efforts in retaining and sustaining sites currently participating in clinical research and building the critical mass of sites conducting clinical research around the globe, with a goal of expanding site membership in SCRS to approximately 5,000 sites in 2015. As the voice of sites to the clinical research community, SCRS provides valuable training, experience and mentoring needed to achieve excellence among sites and establish their ongoing commitment to the conduct of clinical trials, work that INC Research will support through the Circle of Sustainability Sponsorship. Through the expanded relationship, INC Research will be the first CRO to establish a SAG, a new concept currently in use by leading pharmaceutical organizations such as TransCelerate BioPharma and Eli Lilly & Company to facilitate ongoing dialogue with clinical investigators and site professionals worldwide in an effort to improve and drive efficiencies across the clinical development process. Through this approach, INC and investigative sites globally will exchange perspectives and insights on innovative methods, tools and technologies in an effort to enhance clinical research efficiency and more closely align the work of the sites and industry across the research ecosystem. As a Circle of Sustainability sponsor, INC Research will continue to participate on the SCRS’ Global Impact Board and Leadership Council, as well as serve as the sponsor of site appreciation receptions at the society’s annual Site Solutions Summit and regional meetings throughout the U.S. and Europe. INC Research has been actively engaged in supporting the efforts of the society, as well as site engagement overall, through a number of initiatives connecting sites, sponsors and CROs in an ongoing dialogue regarding how to work together more effectively to improve the clinical development process for the benefit of patients. The Company’s final Site Appreciation Reception for 2014 will take place Dec. 7 in conjunction with the 56th American Society of Hematology Annual Meeting in San Francisco. About INC Research INC Research (Nasdaq: INCR) is a leading global contract research organization (CRO) providing the full range of Phase I to Phase IV clinical development services for the biopharmaceutical and medical device industry. Leveraging the breadth of our service offerings and the depth of our therapeutic expertise across multiple patient populations, INC Research connects customers, clinical research sites and patients to accelerate the delivery of new medicines to market. We were ranked “Top CRO to Work With” by sites worldwide in the 2013 CenterWatch Global Investigative Site Relationship Survey. INC Research is headquartered in Raleigh, NC, with operations across six continents and experience spanning more than 100 countries. For more information, please visit www.incresearch.com and connect with us on LinkedIn and Twitter @inc_research. About SCRS SCRS is a global trade organization founded in 2012 which represents over 1,750 research sites, including 26,000 research professionals; 15,000 investigators and 9,000 research staff, in 39 countries. SCRS’ mission is to unify the voice of the global clinical research site community for site sustainability. SCRS has become an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Sites, as well as companies that sponsor or support the work conducted at clinical research sites, will benefit from membership and partnership. Visit myscrs-new.local/.
Contact: Noel Benedetti Phone number: 919-259-0785 Email address: noel.benedetti@duke.edu FOR IMMEDIATE RELEASE Investigator Training Efficiencies Highlighted in New CTTI GCP Recommendations DURHAM, NC, January 29, 2015 – The Clinical Trials Transformation Initiative (CTTI) has announced recommendations to streamline Good Clinical Practice (GCP) training of investigators who participate in clinical trials. GCP is an international standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. According to CTTI’s executive director, Pamela Tenaerts, M.D., MBA, “Sponsors generally require clinical investigators to complete GCP training prior to participating in each clinical trial. This requirement can result in investigators who participate in multiple clinical trials receiving redundant GCP training numerous times within a single year.” “CTTI’s recommendations to eliminate redundant training and for sponsors to accept one another’s training would reduce unnecessary burden on sites and signify a major landmark for U.S.-based clinical research sites,” said Christine Pierre, president, Society for Clinical Research Sites (SCRS). “The Society for Clinical Research Sites is proud to have participated in this important initiative to maximize efficiency in GCP training.” The recommendations, presented in a public webinar hosted by SCRS, focus on four components of GCP training: minimum essential elements, training frequency, training format, and evidence of completion. Adaptability is encouraged as appropriate; for example, the frequency of training should be sufficiently flexible to accommodate different experience levels, gaps in training, etc., and should not be the same course every time. The recommendations were developed by a multi-stakeholder project team that considered the results of a literature review and analysis of some common GCP training programs, as well as discussions with experts on challenges regarding GCP training and possible solutions. The team expects to publish the complete details of the project in a peer-reviewed publication later this year. CTTI was established by Duke University and the FDA as a public-private partnership in 2007, and now comprises more than 60 member organizations working to identify and promote practices that will increase the quality and efficiency of clinical trials. More information about CTTI and its projects is available at www.ctti-clinicaltrials.org. SCRS was founded in 2012 in response to the growing need for a trade organization representative of the needs of clinical research sites globally. SCRS’s mission is to unify the voice of the global clinical research site community for greater site sustainability. Financial support for the work was provided by a grant from the FDA awarded to Duke University for CTTI, as well as pooled CTTI member funds and in-kind contributions. ###
