Kate Dugan, VP Clinical Operations and Strategic Data Strategy will present with John “JJ” Spegele at the 9th annual SCOPE conference. Their presentation entitled, “Real world innovation & application in pipeline data approaches” will be given on February 15th.
The SCOPE (Summit for Clinical Ops Executives) offers three stimulating days of in-depth discussions in 18 different conferences, 3 plenary keynote sessions, and the ever-popular interactive breakout discussions focused on advances and innovative solutions in all aspects of clinical trial planning, management and operations: Site Selection and Management, Patient Engagement, Recruitment and Retention, Protocol Optimization, Feasibility, Data Strategy & Analytics, Sensors and Wearables, Project Management, Outsourcing, Forecasting, Budgeting and Contracting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Post-Marketing Studies, Observational Research, Clinical Supply Chain, and Precision Medicine.
Raleigh, North Carolina. – September 12, 2017, Global Specimen Solutions, Inc. has announced the release of their latest product LabCODE™, a novel Lab Information Management System (LIMS) built for modern laboratory workflows and storage requirements. LabCODE™ offers pre-built capabilities for Biobanking, Pharmacokinetics, Pharmacogenetics, Next Generation Sequencing, Flow Cytometry, Pathology, and much more. LabCODE™ is fully GlobalCODE® ready and can use the predictive analytics of GlobalCODE® to feed the laboratory workflows, then send full data chain-of-custody back to the powerful GlobalCODE® analytic machine.
“We are very excited to bring another innovative solution to the market for our clients to extend their specimen tracking into the laboratory and biobank. The novel LIMS architecture and approach used to build LabCODE™ is another game-changing technological advancement for specimen management. LabCODE™ is fully integrated with the unmatched capabilities of GlobalCODE®, our premier pipeline data management tool, which has revolutionized live specimen tracking, compliance management, and assay result analytics. With the release of LabCODE™, GlobalCODE® now offers a single solution for clinical trial scientists and laboratory scientists to manage and use powerful integrated data generated internally and externally.”–Amelia Wall Warner, Founder and CEO
Read the Full Press Release Here
Raleigh’s Global Specimen Solutions is growing its leadership team ahead of a number of product launches, according to founder and CEO Amelia Wall Warner.
The company has hired Gabriel Balint – owner of laboratory information management system-focused company BGASoft – as senior vice president of Software Development.
Read the Entire Article at TBJ
Raleigh, North Carolina. – June 1, 2017, Global Specimen Solutions, Inc. (www.globalspecimensolutions.com), is pleased to announce the addition of Gabriel Balint as Senior Vice President of Software Development as it grows the leadership team for Software Product development.
“Global Specimen Solutions, Inc. is very excited to have Gabriel join our Senior Leadership team. Gabriel has extensive experience in the Specimen Management Software market and has become known for his innovative, disruptive approach to automation. This is a perfect fit for our business approach in creating fit-for-purpose, new market approaches for specimen based research.”–Amelia Wall Warner, Founder and CEO
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Global Specimen Solutions, Inc. (http://www.globalspecimensolutions.com), was selected by the Triangle Business Journal (TBJ) for 2017 Best CRO for the Life Science Awards and Women in Business, Entrepreneur winner for the CEO, Amelia Wall Warner.
“Global Specimen Solutions, Inc. is thrilled to be recognized for the hard work and innovative market solutions developed by our talented team. Our company is growing rapidly and having this recognition is thrilling for all of us.” –Amelia Wall Warner, Founder and CEO’
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In the HBO movie “The Immortal Life of Henrietta Lacks” based on the best-selling book written by Rebecca Skloot, text appears across the screen in the very last frame that reads “Patient consent is not required for research on human tissue obtained during medical treatment if the “donor’s” identify is removed”. The failure of John Hopkins University to obtain consent from Henrietta Lacks or her family for the use of her cells, which have come to be known as HeLa cells, is also mentioned throughout the movie. As captured by the emotional response of the family in this movie and the perspective of ethicists in the research community, this exemption can be very controversial given the uncertainty as to whether it offers the best protection of privacy to subjects involved in research. In fact, it was just at the beginning of this year that the Continue reading Informed consent perspective in light of the Henrietta Lacks movie
Global Specimen Solutions (GSS) was chosen to receive the 2017 Life Science Award for being a ground breaking organization in the Life Science Industry. Global Specimen Solutions provides innovative pipeline data management, analytics solutions, and services designed to optimize human specimen research. GSS will be presented with the award at a banquet on May 5th in Cary, NC.
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Our Global Specimen Solutions team members of Amelia Wall Warner, Melissa Rawley-Payne and L. Scott Clark are excited to meet you at ISBER in Toronto from May 9-12th.
ISBER is a global biobanking organization which creates opportunities for networking, education, and innovations and harmonizes approaches to evolving challenges in biological and environmental repositories.
Continue reading Global Specimen Solutions Presents at ISBER
WBENC’s Summit engages participants to focus on the future of various industries, business networking, and development opportunities for women. The program highlights the 2016 America’s Top Corporations for Women Business Enterprises. The Summit occurs on March 21 – 23, 2017 in New Orleans, LA. The Women’s Business Enterprise National Council (WBENC), founded in 1997, is the largest third-party certifier of businesses owned, controlled, and operated by women in the United States. WBENC, a national 501(c)(3) non-profit, partners with 14 Regional Partner Organizations to provide its world class standard of certification to women-owned businesses throughout the country.
On January 19, 2017, the U.S. Department of Health and Human Services along with 15 other federal departments and agencies issued a revised Federal Policy for the Protection of Human Subjects referred to as the Common Rule. The intent of the revision, the first update since 1991, was to strengthen the protections of subjects participating in research while at the same time minimizing undue burden on researchers. At a recent webinar led by Pearl O’Rourke and Heather Pierce through PRIM&R, several key take-away messages were identified by GSS attendees and have been outlined below with some additional commentary on potential impact and considerations. Although it is important to be familiar with all the changes and updates in the policy, the primary focus here will be on those changes most relevant to research with biospecimens and informed consent.
Continue reading Updates to Common Rule