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

GlobeNewswire Distribution ID 9146941

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

GlobeNewswire Distribution ID 9146941

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

Precise, Reliable Geospatial Data System Crucial to Realize Dev’t Goals: Urban, Infrastructure State Minister


Addis Ababa: Ensuring precise, reliable and consistent geospatial data system is essential to realize sustainable developmental ambitions in all spheres, Urban and Infrastructure State Minister Wondimu Seta said.

A National Geodetic Infrastructure Workshop organized by Space Science and Geospatial Institute (SSGI) was held in Addis Ababa today.

Opening the workshop, the state minister pointed out that reinforcing efforts in building geospatial data system in a more collaborative and integrated manner is instrumental in ensuring precise, reliable and consistent data that realize sustainable developmental ambitions in all spheres.

Geospatial data system is the backbone of infrastructural and other developmental activities, he said, adding that it has also huge role in urban development, managing land resources at the national level and to build an integrated land data system, among others.

Noting that ensuring smart cities, building huge infrastructure and construction works need precise and reliable data,
he said making the data system consistent is critical to realizing prosperous Ethiopia.

For Wondimu, the land infrastructure data system has to be consistent across the nation.

Therefore, the national workshop is mainly aimed at sharing idea, experiences and laying a foundation to work together toward ensuring integrated data system at national level.

Addressing the workshop, Space Science and Geospatial Institute (SSGI) Director General Abdisa Yilma stressed the need for active participation of all pertinent stakeholders both at federal and regional levels in building the geodetic infrastructure.

More specifically, he added that infrastructural and higher educational institutions have huge role to play in building an integrated and up-to-date geodetic infrastructure.

Stating the significant role of the participation of the private sector, the director general said that reinforcing the engagement of the private sector and other pertinent stakeholders will be pivotal to join human and financial resources.

As part of the private sector participation, SSGI signed a Memorandum of Understanding (MoU) aimed at enhancing the quality and coverage of aerial images with the private National Airways today.

Source: Ethiopian News Agency

Minister issues 10-day suspension to Men Travel, interurban transport agency


By Stephen TADAHA

Men Travel Agency was issued a 10-day suspension for its involvement in two fatal road accidents between May 27 and 29, 2024.

The suspension was announced in a release on Thursday, May 30, by the Minister of Transport, Jean Ernest Massena Ngalle Bibehe.

‘Results from preliminary investigations reveal that both accidents occurred under similar circumstances and were linked to human factors,’ reads the communique.

The first accident occurred in Yaoundé, while the second happened in Douala, resulting in 2 deaths and 6 injuries, according to the ministry.

As a result, the minister has imposed a 10-day ban on the interurban transport agency. After the suspension period, only buses equipped with passenger security measures will be authorized to operate, following a technical inspection by competent authorities.

Additionally, the two drivers involved, Mr. Amougou Minkoulou Jean Ive and Minko Mi Assum Joseph Desire, have been issued a one-year suspension, and their driver’s licenses have been
withdrawn.

The minister urged owners of interurban travel agencies to install video surveillance equipment in their buses to prevent accidents, warning that defaulters shall face the same fate.

Source: Cameroon News Agency

Southwest Stakeholders Gather to Launch Development Plan


CNA Regional Writer

Southwest, Cameroon

Stakeholders of the Southwest region convened under the chairmanship of Paul Tassong, Minister Delegate to the Minister of the Economy, Planning, and Regional Development, to evaluate the Territorial Planning and Sustainable Development Plan. The plan, slated for imminent launch, underwent scrutiny during a workshop on May 31, 2024. Attendees included representatives from traditional, Regional Assembly, Municipal Authorities, and other stakeholders.

Tassong emphasized a bottom-up development approach, in line with legislation enacted in 2011 empowering the government to plan spatial use alongside Cameroon’s long-term development vision. He underscored the importance of enhancing knowledge of the territory to improve living standards.

Among the participants was HRM Atem Ebako, President of the Southwest House of Chiefs, who emphasized the strategic significance of the planning process in translating ideas into actionable plans. He highlighted the meeting’s role in c
ommunicating the government’s development objectives for the Southwest region to all stakeholders and field actors.

Source: Cameroon News Agency

Africa day, time to reflect on our culture


By Tanaka Chikomo

For some, culture is a distant concept that is only relevant on public holidays or feasts such as Africa Day, Culture Week, religious celebrations, or festivals such as Ngondo and Nyem-Nyem. However, for many writers and cultural enthusiasts, this term represents more than one distinct period of exuberant atmospheres, colourful dressing and assorted traditional meals. It shapes the way of life and the attitudes of a people (Edgerton 1965, 443); it serves as a legacy for communities’ future generations (Elias 1978b, 130) and a mechanism put in place to regulate both the internal and external environments of a community (Turner 1969, 98). However, the existence of various definitions does not necessarily mean the idea of culture is exempted from criticism and uncertainty, as highlighted in Matthew Thomas Johnson’s 2013 assessment of this phenomenon (Evaluating Culture pp 97-119). With the aid of cultures in Côte d’Ivoire, this short writeup aims to embrace the various representations of cult
ure and the power of the latter.

For certain philosophers, culture is a legacy (Elias 1978b, 130). When one thinks of anything legendary, the words long-lasting, established and investment might come to mind. During an encounter with Mama Suza at Pôle Technique, Bingerville, an avid gardener and homemaker, she expressed that culture can easily be passed on from one generation to the next, and that it is important for the current generation to learn from the elements of their grandparents’ cultures to enrich the cultural experience. This is a potent observation to note because the implication is that culture is not only a legacy that needs to be maintained, but a structure that also needs constant revival by the present generation. If a grandmother used to practice the tradition of storytelling with all her grandchildren, then the latter can also continue this activity and reinvent it to compliment the modern digital age. Culture therefore seems to represent something more than just than distinct celebrations
and festivals.

Mama Suzy, a homemaker, and avid gardener

While culture is more than vibrant feasts, it would be unjust to dismiss festivals and parades as an essential part of a people’s culture as they have the capacity to shape the minds of a community. For example, Ivorians partake in the annual SARA (Salon Internationale de l’Agriculture et des Ressources Animales), where business owners and agriculturalists present the process of manufacturing their products, from handbags made from cotton plants to attiéké made from cassava. Even though commercial activity is central to SARA, it is an opportunity to transform the minds of citizens while they get to enjoy dance, music, tasting new products, trying on new jewellery, or simply discussing with experts on the preparation of a particular spice. Thus, Edgerton’s former claim that culture seeks to shape the attitudes of a people’s mind is plausible.

The different types of attiéké made from manioc( Cassava)

Handbags made from cotton plants- SARA exhibition.

M
oreover, the concept of culture is seen as a mechanism to regulate the functioning of societies. In March 2023, representatives of WANEP (West African Network for Peacebuilding) travelled across 11 villages in the Haut-Sassandra and Hambol regions of Côte d’Ivoire. The mission’s objective was to present a project on accompanying 500 residents to obtain their national identification and birth certificates in accordance with the 2018-863 law, through WANEP’s Democracy and Good Governance programme. The team met with the local authorities (chiefs and council members) to take them through the importance of having national identification, before voting for the 2025 presidential elections commences.

Chiefs for the different villages in the department of Niakara,

Hambol, Ivory Coast

This interaction, though it was to encourage a democratic spirit in some of the overlooked regions of the country, highlights the significance of culture and how it coincides with the law. The project could not be presented if the chi
efs and the required participants of the respective regions were absent, indicating that even in external projects, the culture of a village cannot be compromised. One might also argue that this resistance to compromise shows the power of law over communities instead of the inherent force of culture. However, women in villages such as Arikokaha, for example, served the WANEP team a variety of traditional meals such as Agouti and Tchep, reflecting a certain level of cultural control in maintaining hospitality through offering homecooked meals to visitors on mission, regardless of the professional purpose of the mission itself. Given this position, culture is undoubtedly a means to regulate a community and to share its values with those who interact with it.

In conclusion, culture is clearly a multi-faceted concept because it covers a variety of functions in society, some of which have been explained above. While this is not an exhaustive account of what culture represents today, the above examples might give
some insight into the power, importance, and depth of culture on those in society. It is not merely about a single day to celebrate culture, it is also about sharing the culture so that it remains strong for future generations, ensuring that it is somehow regulated and preserved in a world that is ever-changing and developing.

Source: Cameroon News Agency