Fortrea Apresenta Solução Abrangente para Aprimorar a Diversidade e Inclusão na Pesquisa Clínica

Utilizando dados do mundo real, insights de pacientes e um processo sistemático para a criação, operação e análise da eficácia dos planos de ação de diversidade em ensaios clínicos

DURHAM, N.C., May 31, 2024 (GLOBE NEWSWIRE) — A Fortrea (Nasdaq: FTRE) (a “Empresa”), uma organização líder global de pesquisa por contrato (CRO), anunciou hoje o lançamento da sua solução abrangente e integrada para a melhoria da diversidade e inclusão (D&I) dos participantes em ensaios clínicos. A solução de D&I da Fortrea foi projetada para expandir o acesso dos pacientes a participar de ensaios clínicos e atender aos requisitos da Food and Drug Administration (FDA) dos EUA, sob a Lei de Reforma Omnibus de Alimentos e Medicamentos, para aumentar a inscrição de populações sub-representadas em ensaios clínicos.

O processo abrangente da Fortrea integra cinco componentes do planejamento e execução de ações de diversidade:

  • Consultores de evidências do mundo real pesquisam conjuntos de dados relevantes do mundo real para informar o planejamento da diversidade.
  • Especialistas em regulamentação, desenvolvimento e operações clínicas elaboram o Plano de Ação de Diversidade, validam com grupos de pacientes e negociam com os reguladores.
  • As equipes operacionais acessam várias plataformas de dados, o Conselho Consultivo de Locais da Fortrea e soluções habilitadas por tecnologia para implementar o Plano de Ação de Diversidade como parte integrante da execução dos ensaios clínicos da Fortrea.
  • O monitoramento e os relatórios são habilitados pelo exclusivo Painel de Insights de Estudo de Diversidade e Inclusão da Fortrea, fornecendo dados e visualizações acionáveis para o gerenciamento contínuo do estudo.
  • Escritores técnicos de relatórios experientes compilam dados e preparam relatórios para envio regulatório, com suporte regulatório contínuo fornecido como parte da solução de D&I.

“A pesquisa clínica que reflete uma população representativa fornece uma melhor visão de como um tratamento potencial funcionará em um ambiente do mundo real”, disse John Doyle, DrPH, presidente da Fortrea Consulting. “Requisitos regulatórios recentes codificam o progresso dos últimos anos na abordagem biofarmacêutica para aumentar a inclusão de diversas populações nos seus programas de desenvolvimento. A solução da Fortrea traz uma profunda experiência em dados do mundo real para projetar planos de D&I eficazes e realistas, juntamente com mais de 30 anos de experiência em mais de 20 áreas terapêuticas na execução de testes. Também temos um compromisso firme com a D&I, não apenas nos ensaios clínicos, mas em toda a nossa empresa, à medida que buscamos nosso propósito de oferecer tratamentos que mudam a vida dos pacientes mais rapidamente.”

A solução de D&I da Fortrea incorpora uma série de ferramentas proprietárias, incluindo avaliações epidemiológicas e de viabilidade que utilizam uma combinação exclusiva de grandes conjuntos de dados. A solução também integra contribuições de grupos de pacientes para criar insights sobre a tolerância ao protocolo e os requisitos de suporte à conduta do estudo em diferentes populações de pacientes em várias áreas e geografias da terapia. Esses insights informam os planos globais e locais de recrutamento e retenção de pacientes para o alcance de populações de pacientes sub-representadas e abordagem das barreiras à participação de ensaios clínicos.

“Para a garantia da inclusão de diversas populações de pacientes em ensaios clínicos precisamos ir além de um plano, precisamos ter discernimento e agir”, disse Mark Morais, diretor de operações da Fortrea. “Devido ao nosso abrangente programa Voz do Paciente e à nossa colaboração com diversos locais de pesquisa e redes de locais, temos um profundo entendimento do que é necessário para o sucesso no alcance de populações que tradicionalmente têm sido sub-representadas nos ensaios clínicos. Na Fortrea, somos informados pelos dados do mundo real, habilitados pelas tecnologias inovadoras e impulsionados pela nossa paixão em oferecer novas terapias para todos os pacientes.”

Visite Diversidade e Inclusão em Ensaios Clínicos em Fortrea.com para mais informação.

Sobre a Fortrea

A Fortrea (Nasdaq: FTRE) é fornecedora líder global de soluções para o desenvolvimento clínico e acesso ao paciente para a indústria de ciências da vida. Fazemos parcerias com grandes e emergentes empresas biofarmacêuticas, de biotecnologia, de dispositivos médicos e de diagnóstico para impulsionar a inovação na saúde que acelera terapias que mudam a vida dos pacientes. A Fortrea fornece gerenciamento de testes clínicos de fase I-IV, farmacologia clínica, serviços de consultoria, soluções de testes com tecnologia diferenciada e serviços pós-aprovação.

As soluções da Fortrea utilizam suas três décadas de experiência abrangendo mais de 20 áreas terapêuticas, sua dedicação ao rigor científico, insights excepcionais e uma forte rede de pesquisadores. Nossa equipe talentosa e diversificada que trabalha em mais de 90 países é dimensionada para fornecer soluções focadas e ágeis para clientes de todo o mundo.

Saiba mais sobre como a Fortrea está se tornando uma força transformadora de pipeline para paciente na Fortrea.com e siga-nos no LinkedIn e X (antigo Twitter) @Fortrea.

Contatos da Fortrea:
Fortrea para Mídia: Galen Wilson – 703-298-0802, media@fortrea.com
Fortrea para Mídia: Kate Dillon – 646-818-9115, kdillon@prosek.com

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Fortrea lance une solution complète pour améliorer la diversité et l’inclusion dans la recherche clinique

Exploitation des données en conditions réelles, des connaissances des patients et adoption d’un processus systématique pour développer, concrétiser et mesurer l’efficacité des plans d’action en faveur de la diversité dans les essais cliniques.

DURHAM, État de Caroline du Nord, 31 mai 2024 (GLOBE NEWSWIRE) — Fortrea (Nasdaq : FTRE), ci-après la « Société », une organisation de recherche contractuelle (ou ORC) leader d’envergure mondiale, annonce ce jour la sortie de sa solution complète et intégrée ciblée sur l’amélioration de la diversité et de l’inclusion des participants aux essais cliniques. La solution « Diversité et Inclusion » développée par Fortrea est conçue pour élargir l’accès des patients aux essais cliniques et répondre aux exigences de la loi fédérale Food and Drug Omnibus Reform Act édictée par l’administration américaine des denrées alimentaires et des médicaments, la Food and Drug Administration, ou « FDA » visant à renforcer le recrutement des populations sous-représentées dans les essais cliniques.

L’approche globale de Fortrea intègre cinq axes de planification et d’exécution d’actions en faveur de la diversité :

  • Recherche des ensembles de données pertinentes en conditions réelles pilotée par les conseillers en vue de contribuer à la planification de la diversité.
  • Mise au point du plan d’action en faveur de la diversité élaborée par les experts en réglementation, développement et services cliniques, validation auprès des groupes de patients et négociations avec les autorités de tutelle réglementaires.
  • Mise en accès à de multiples plateformes de données pour les équipes opérationnelles, ainsi qu’au comité consultatif de site et à des solutions technologiques pour actionner le plan d’action en faveur de la diversité, pleinement intégré à l’exécution des essais cliniques à la main de Fortrea.
  • Suivi et reporting assurés par le tableau de bord exclusif de la solution dédié aux éclairages sur les données relatives aux notions de diversité et d’inclusion des études (Diversity and Inclusion Study Insights Dashboard), fournissant des données et des graphiques exploitables dans le cadre de la gestion continue de l’étude.
  • Compilation des données effectuée par des rédacteurs techniques expérimentés veillant également à la préparation des rapports en amont des dépôts auprès des autorités réglementaires, et appui réglementaire permanent intégré à la solution.

Pour John Doyle, docteur en santé publique et Président de Fortrea Consulting, « La recherche clinique reposant sur une population représentative donne une meilleure idée des modalités de fonctionnement d’un potentiel traitement en conditions réelles. Les nouvelles exigences réglementaires traduisent les progrès réalisés ces dernières années dans l’approche biopharmaceutique visant à améliorer l’inclusion de populations diverses au sein des programmes de développement. La solution de Fortrea apporte une expertise approfondie des données en conditions réelles pour concevoir des plans ciblés sur la diversité et l’inclusion efficaces et réalistes, et plus de 30 ans d’expérience dans plus de 20 disciplines thérapeutiques en matière d’exécution d’essais. Notre engagement sans faille envers la diversité et l’inclusion dépasse les frontières des essais cliniques pour s’étendre à l’ensemble de notre entreprise, à l’heure où nous poursuivons notre objectif de mettre plus rapidement à la disposition des patients des traitements susceptibles de changer leur vie ».

La solution « Diversité et Inclusion » développée par Fortrea intègre une série d’outils exclusifs, notamment des évaluations épidémiologiques et de faisabilité qui s’appuient sur une combinaison exclusive de vastes ensembles de données. Elle intègre également des données provenant de groupes de patients pour fournir des éclairages sur la tolérance au protocole et les exigences en matière de soutien à la conduite de l’étude pour différentes populations de patients, dans plusieurs disciplines thérapeutiques et territoires. Ces éclairages permettent d’élaborer des plans de recrutement et de fidélisation des patients à l’échelle mondiale et locale, d’atteindre les populations de patients sous-représentées et d’éliminer les obstacles à la participation aux essais cliniques.

« Garantir l’inclusion de diverses populations de patients dans les essais cliniques doit s’entendre au-delà d’un plan, ce qui demande de la perspicacité et de l’action », observe Mark Morais, chef de l’exploitation de Fortrea, avant d’ajouter : « Grâce à notre programme complet Voice of Patient (la voix des patients) et à notre collaboration avec divers centres investigateurs et réseaux de centres, nous comprenons parfaitement ce qu’il faut faire pour toucher les populations habituellement sous-représentées dans les essais cliniques. Chez Fortrea, nous nous appuyons sur des données en conditions réelles issues de technologies innovantes, et nous sommes animés d’une passion axée sur la proposition de nouveaux traitements à tous les patients. »

Pour en savoir plus, veuillez consulter la page Diversité et inclusion dans les essais cliniques sur le site Fortrea.com.

À propos de Fortrea

Fortrea (Nasdaq : FTRE) figure parmi les principaux fournisseurs de solutions de développement clinique et d’accès aux soins pour les patients dans le secteur des sciences de la vie. Nous nous associons à des entreprises émergentes et établies du secteur biopharmaceutique, de la biotechnologie, des dispositifs médicaux et du diagnostic pour stimuler l’innovation dans le domaine de la santé et accélérer la mise à disposition de traitements révolutionnaires pour les patients. Nous proposons des services de gestion d’essais cliniques de phase I à IV, de pharmacologie clinique, de conseil, d’essais différenciés axés sur des technologies habilitantes, et des services post-autorisation.

Nos solutions s’appuient sur 30 ans d’expérience dans 20 disciplines thérapeutiques, une passion pour la rigueur scientifique, des connaissances exceptionnelles et un solide réseau de centres de recherche. Notre équipe talentueuse et diversifiée répartie dans plus de 90 pays est dimensionnée pour fournir des solutions ciblées et agiles à nos clients, partout dans le monde.

Pour en savoir plus sur la manière dont Fortrea est moteur d’influence du pipeline au patient, consultez le site Fortrea.com et suivez-nous sur LinkedIn et X (anciennement Twitter) @Fortrea.

Coordonnées :
Relations médias : Galen Wilson – 703-298-0802, media@fortrea.com
Relations médias : Kate Dillon – 646-818-9115, kdillon@prosek.com

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EB5 Capital Receives I-956F Approvals for San Luis Obispo Marriott Hotels (JF31) and SouthFace Village at Okemo (JF36) Projects

WASHINGTON, May 30, 2024 (GLOBE NEWSWIRE) — EB5 Capital is pleased to report that its San Luis Obispo Marriott Hotels (JF31) project and SouthFace Village at Okemo (JF36) project were both approved by the United States Citizenship and Immigration Services (USCIS) in May 2024. Since the EB-5 Reform and Integrity Act of 2022 (RIA) was enacted, EB5 Capital has obtained Form I-956F project approvals across a total of nine EB-5 projects.

These Form I-956F approvals signify that USCIS, the government agency that oversees the EB-5 Immigrant Investor Program, has assessed, and verified the compliance of the EB-5 project. An I-956F project approval is also required prior to USCIS adjudicating individual I-526E petition approvals, the application for a foreign investor to secure conditional permanent residency in the United States.

“We are happy to see more of these project approvals come through, especially on our first rural deal in this post-RIA landscape,” said Brian Ostar, President of EB5 Capital. “SouthFace Village at Okemo is an exciting project, and we are confident its development is going to further enhance the local Okemo Mountain community and its year-round activities in central Vermont.”

SouthFace Village at Okemo (JF36) is a for-sale luxury ski-in and ski-out residential development on the southeast face of Okemo Mountain Resort in Ludlow, Vermont. As a rural Targeted Employment Area (TEA), this project qualifies for priority processing with USCIS. The recent Form I-956F project approval was granted within six months after the application was filed.

San Luis Obispo Marriott Hotels (JF31), the other EB5 Capital project recently approved by USCIS, is a four-story Marriott dual-branded Residence Inn and SpringHill Suites hotel in San Luis Obispo, California. The project is designated as a high unemployment TEA and was one of EB5 Capital’s first EB-5 raises under the new EB-5 legislation. Both JF36 and JF31 are currently under construction and are expected to generate over 1,300 jobs in total.

Now that both projects are approved with USCIS, EB5 Capital is looking forward to receiving individual I-526E petition approvals soon. The firm will continue to track the remainder of the construction process and support its investors with the completion of their immigration journey to the United States.

About EB5 Capital

EB5 Capital provides qualified foreign investors with opportunities to invest in job-creating commercial real estate projects under the United States Immigrant Investor Program (EB-5 Visa Program). Headquartered in Washington, DC, EB5 Capital’s distinguished track record and leadership in the industry has attracted investors from over 75 countries. As one of the oldest and most active Regional Center operators in the country, the firm has raised over $1 billion of foreign capital across approximately 40 EB-5 projects. 100% of our investors’ funds are protected by the Federal Deposit Insurance Corporation (FDIC) insurance prior to their deployment into our projects. Please visit www.eb5capital.com for more information.  

Contact:
Katherine Willis
Director, Marketing & Communications
media@eb5capital.com

GlobeNewswire Distribution ID 9146250

Sh63.5 Million Water Project To Address Water Shortage


It’s a sigh of relief for more than 30,000 Laikipia North residents following the launch of a Sh63.5 million dam in Doldol that is expected to address water crises in pastoral areas.

The 100,000-cubic-meter-capacity dam funded by the Ewaso Ng’iro North Development Authority (ENNDA) will provide water in the four communities of Ilgwesi, Ilmokodo, Ilmumonyot, Indikiriri, and Samburu County.

Doldol Dam Chairman Solomon Ole Pusi revealed that the dam, which was initially constructed by locals in the 1950s, had silted, but with the major boost from the government, water shortages will be a thing of the past for both people and wild animals.

”We are glad about the work being done here. With the enlargement of the dam and desilting, we hope that water challenges will be addressed. It’s sad that, even after the rainy season, we are left with no water for our livestock,’ said Ole Pusi, adding that during the drought season, they were forced to migrate to Mount Kenya forest in search of water for their livestock.

A
rea Member of Parliament Sarah Korere lauded the project, noting that pastoralists were severely affected by drought over the years and that water provision would be a game changer for the communities in her constituency.

According to ENNDA Director Corporate Services and Infrastructure Josiah Mulwa, the dam will be constructed within a period of six months, and it will be installed with a solar system for water pumping aimed at promoting green energy in the pastoral area.

‘This is a water-scarce area. Women, livestock, and children trek long distances to access water commodities, which is a major challenge. Upon completion of this project, many households will benefit,’ said Mulwa.

On his part, ENNDA Chairman Ahmed Duale said the construction of the dam would improve residents’ livelihoods and reiterated that the project will address the water shortage in the vast Laikipia North sub-county.

The chairman urged residents to support the project until its completion to ensure reliable water points for their
domestic usage.

Source: Kenya News Agency

Youth Encouraged To Participate In Budget-Making Process


Youth from Kericho County have been urged to actively participate in the budget-making process by submitting development projects.

The call was made during a sensitization forum in Kericho courtesy of the Emerging Leaders Foundation-Africa (ELF-Africa), revealing that in Kenya, approximately 75% of the population is under the age of 35 years, a demographic significantly affected by the budget-making process as it impacts key areas such as education, employment, healthcare, and social services, which are critical for their development and future opportunities.

While making her presentation, the ELF Africa budget facilitator, Diana Chepkorir, highlighted the critical role of public participation by the youth in fostering good governance, especially within Kenya’s decentralized government system, adding that transparency and social accountability will help the government spend on critical sectors that touch on the youth.

She said, their contribution can lead to more transparent and accountable governance, as
they are more likely to demand and ensure accountability. Policies crafted with youth input are more likely to address long-term challenges such as education, employment, and climate change, creating a sustainable future for all.

‘Young people bring innovative ideas and fresh approaches to addressing economic and social challenges, and that is another reason why we are championing for their participation in not only the budget-making process but also governance and policy issues,’ said Chepkorir.

Meanwhile, ELF Africa Governance and Civic Engagement Lead, Mr. Robert Mwangi, who spoke to KNA, said the workshop sought to empower young people, increasing their influence in developmental processes and enabling them to contribute meaningfully to governance.

‘We prioritize engagement and training by organizing youth-centered workshops to highlight how public participation is feasible at all levels, from the village to the county. The governments could provide training for youth on how to self-organize and turn t
heir ideas into actionable proposals’ said Mwangi.

The over 50 youth representatives present at the workshop were enlightened on a variety of issues, including early pregnancies across Kericho County, with an emphasis on the need for responsive budgeting to allocate resources towards education and health services to mitigate the challenge.

They were also sensitized on matters of climate change and how local policies can be adapted to address environmental sustainability and resilience, such as actively participating in frequent tree planting activities to increase the forest cover in the county.

The seminar was conducted at the ACK conference hall in Kericho town.

Source: Kenya News Agency

Leveraging Innovative Technologies To Transform Agriculture


It is getting more difficult for farmers to adapt to climate change, and we need better-performing, more resilient agricultural technologies, African Development Bank Group President Dr. Akinwumi Adesina has said.

Dr. Adesina, who was speaking on the sidelines of the AFDB conference on leveraging the Consortium of International Agricultural Research Centre’s (CGIAR) technologies for Agricultural Transformation in Africa, noted that the capacity to adapt to climate change means that we have to continue to fund R and D.

‘There is no part of the world that has been able to achieve significant productivity growth and also transform agriculture without using CGIAR planting materials (Germplasm) technologies, which is very important,’ he said.

Dr. Adesina emphasized on the need to take the technologies that we have to the farmers. ‘What use are technologies that sit on the shelf? We need to do top-notch research and translate the R and D into real technologies that are adaptive, accessible, and highly productiv
e to allow smallholder farmers to raise their productivity.’

Countries, he noted, have to make sure that the CGIAR works very closely with national and regional agricultural research centers and also works very closely with the private sector to deliver results at scale.

Dr. Adesina applauded the CGIAR work on the technologies for African agricultural transformation, saying that the phenomenal work is an architecture that builds together the R and D system globally, nationally, and in the private sector and puts the best-performing technology in the hands of farmers.

He mentioned the technologies in maize, wheat growing in heat-tolerant varieties, and rice varieties that are being grown in low-land areas that have triple productivity, and this shows that Africa has the technology to feed itself.

Dr. Adesina, however, said that with all the technology, political will is a must. ‘Everything we do, we cannot succeed unless you have political support. The Green Revolution in Asia happened because of political
support. Our issue is political support and platform policy support to scale it, and that is exactly the same thing they did in Asia,’ he added.

He noted that Africa today has the Food and Agricultural Delivery Compact in 43 countries, where the work of CGIAR is ongoing with national and regional R and D systems that can feed into these particular platforms where there is policy support.

When it comes to agricultural feeding, Dr. Adesina said Africa should never be begging for food. Considering 65 per cent of the uncultivated arable land in the world is in Africa, ‘What Africa does with that agricultural budget is going to be the future of food in the world,’ he emphasized.

Going forward, the President said there will be a need to have a structural transformation of the labor composition of the agricultural sector because a lot of the farmers that we are supporting today with all these technologies have to change.

‘People are using drones. They are using automation; they are using all manner of big data a
nalytics to look into weather patterns, predict them, and get them to the hands of farmers,’ Dr. Adesina said.

Dr. Adesina said that at the African Development Bank, they have a programme called ‘Enable Youth in Agriculture,’ where they have already put in USD 490 million to support over 43,000 young people in agriculture, creating more than 63,000 jobs.

Chair CGIAR Dr. Lindiwe Sibanda said the programme cannot scale up without partners who know how to take the technologies from the shelf to the people who need them the most, and that is farmers.

She noted that CGIAR had neglected the grandmother, orphan, and women crops but now has embraced the Vision for Adapted Crops and Soils (VACS) programme that will be implemented mainly in Africa, looking at what we now call opportunity crops.

‘Most of those grandmother crops are what hold the answer for nutrition density and climate resilience. We are not afraid of the challenge of feeding 2.5 billion people by 2050 because we have the tools,’ she said.

Dr. Siba
nda explained that what Africa needs to do is make sure we deliver them in a climate-smart manner, but also go back to the gene banks to make sure what we thought had no commercial value now delivers food that makes sure we are nutritionally fed, but more importantly, we eradicate hunger.

During the meeting, Technology for African Agricultural Transformation (TAAT), a programme that increased agricultural productivity in Africa by deploying proven high-performance agricultural technologies currently in over 45 countries, including Kenya, was praised for raising food productivity in Africa.

Agriculture remains a cornerstone of Africa’s economy, providing livelihoods for most of the population and serving as a critical sector for economic growth and food security.

Source: Kenya News Agency