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

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

NGO targets 40,000 youths for job opportunities in ‘Waste4Meal’ farming


An NGO, Agricultural Social Entrepreneurship Foundation (ASEF), has said that no fewer than 40,000 Nigerian youths will be trained for job opportunities in its ‘Waste4Meal’ farming project.

The ASEF President, Mr Oluwole Azeez, made this known while signing a Memorandum of Understanding (MoU) with New Generation Nutrition (NGN) and FIDAS African, at International Institute of Tropical Agriculture (IITA), Ibadan, on Friday.

The News Agency of Nigeria (NAN) reports that Waste4Meal is the conversion of wastes into useable agricultural products, such as fertilisers, animal feeds and oil.

Azeez said that 40,000 Nigerians and no fewer than 100,000 African youths and women would be trained on Black Soldier Fly farming and waste aggregation recyclination, with the aim of making them earn a living, promote food security and reduce poverty.

He said that the trainees would be divided into clusters that would spread across all the states in Nigeria and other Africa countries like Ghana, South Africa, Liberia, Uganda
and Cameroon.

‘The cluster persons will create farm for them and work with investors that will bring money into the project for them.

‘I believe that Nigeria can feed itself if the citizenry taps into the project,’ he said.

Azeez said that Nigeria, being the biggest importer of animal feeds in Africa, imported the protein components of animal feeds which could be generated locally, using food waste and other organic waste and black soldier fly.

‘The banana peels, remnant of amala and rice can be converted into fertiliser and protein that fishes and pigs can eat and as well converted into oil we use in frying meat,’ Azeez said.

Also speaking, the ASEF Chief Executive Officer, Mrs Rosemary Adebayo, said the objective of the MoU was to create awareness and empowerment in inset farming industry and introduce Africans into the waste4meal project.

‘We intend to promote alternative sources of protein for farmers to reduce the difficulty they face in the agricultural sector in Nigeria and reduce the amount spen
t on animal feeds.

‘Waste4meal project is about training people the whole value-chain of the black soldier fly profitability,’ she said.

In her remarks, the FIDAS Africa Executive Director, Mrs Omolola Elsie, said that the organisation, being a decentralised online training platform focusing on agriculture, would ensure the success of the training.

Elsie said that her platform would be used to implement all the training component of the project.

Also speaking, the representative of NGN, Mr John Olabisi, said that the project would address the problem of food and livestock feed insufficiency in Nigeria.

In his own contribution, Dr Debo Akande, Director of Business Incubation Platform (BIP), IITA, and Executive Adviser to Oyo State Governor on Agricbusiness, commended the project organisers.

Akande, represented by the IITA Head of Social and Corporate Governance, Mr Wale Oladokun, said that it was a thing of joy for people to be trained and be made to turn the outcome of such training into profitable ways

Source: News Agency of Nigeria

Church plays important role in transforming lives – VC


The Vice-Chancellor of Bingham University, Karu, Nasarawa State, Prof. Kuje Ayuba, said the church has important roles to play in the development and transformation of lives.

Ayuba said this at a public lecture with the theme ‘Empowering The Church for Greater Societal Impact’.

The Vice-Chancellor said that there was no better time to discuss the topic than now.

‘The church is expected to play an important role in the transformation of social, political, economic lives of the citizens.

‘It is also expected to put society in a holistic growth and development oriented direction,’ he said.

Ayuba, while referring to the church as not just the building, but individuals, said he believed that the solution to the national and global crisis was in the church.

The guest speaker, Prof. John Kennedy Opara, while delivering a lecture, said the church held immense potential for catalysing positive change and fostering societal impact.

Opara, the Chief Executive Officer (CEO) of CSS Group, one of the largest farms
in Karu, said the church plays a multifaceted and pivotal role in the society.

According to him, the church as individuals (citizens), helps in encompassing spiritual, social and humanitarian dimensions of citizens.

‘The church is vital for community engagement and support in contemporary society.

‘One of its fundamental roles is to promote social cohesion and unity.

‘The present church must be equipped so as to give life a meaning,’ Opara said.

He said that understanding societal challenges comes in different approaches.

According to him, they include; identifying key societal issues, analysing root causes, engage stakeholders and partnerships among others.

He admonished the church to build up men and women of compassion, generosity that would work with dignity.

‘The church must encourage its members to engage in productive work that contribute to personal well being and the common good of the society.

‘The church should engage in continuous training of members through job entrepreneurship, and job
skill training for empowerment of their future.

‘It must also introduce microfinance and small business support which in time, people will stand on their own rather than depending on their certificate for job,’ Opara added.

Opara said that the church could offer technical assistance to people to help them stand on their feet.

‘When you keep mentoring people and some of them get into what you are doing, the story will be a different thing entirely,’ Opara said.

Making reference to Israel with strong economy, due to investment on food sustainability, Opara said Nigeria equally needed strong economy by empowering individuals to do same.

‘vision is superior to strength and when God put something in our hand, He expect us to use it, as such, the church must never relent in training.

He advised the church to always pray and engage in the word of God.

A staff of the university, Mrs Helen Solomon, who spoke with NAN said the lecture was inspiring.

Solomon appreciated the VC for bringing such an idea, saying t
hat she has been impacted by the lecture.

She said she has already started considering getting into farming rather than waiting and depending on salary always.

Miss Anna Ari, a Law student of the institution said she now understood that vision was a big force that drives an individual.

Ari said that the lecture also taught her that praying for God’s guidance was needed in the pursuit and execution of ones vision.

Source: News Agency of Nigeria

Anniversary: Miyetti Allah hails Tinubu, demands commission for nomadic education


Miyetti Allah Cattle Breeders Association of Nigeria (MACBAN) has commended President Bola Tinubu’s commitment to developing Nigeria’s infrastructure, agricultural sector and enhanced security since his assumption of office.

The National President of MACBAN, Alhaji Baba Othman-Ngelzarma, made the commendation in a congratulatory letter to Tinubu, which was made available to the News Agency of Nigeria (NAN)on Friday in Abuja.

‘ Congratulations to Mr President and Commander-In-Chief of the Federal Republic of Nigeria, Alhaji Bola Tinubu on your one year in office.

‘ On behalf of the over six million pastoral communities in Nigeria, the Chairman, Board of Trustees, the National Executive, Management and staff of MACBAN, I wish to congratulate you on your successful one year anniversary in office.

‘ Your one year in office, though tumultuous but stands you as a man of courage, conviction and vision with Renewed Hope to make Nigeria great.

‘ Your commitment to developing Nigeria’s infrastructure, agricultura
l development and enhanced security is a testimony that you are not only up to the task but to deliver dividends of democracy to the larger Nigerians populace.’

Othman-Ngelzarma noted that the Renewed Hope agenda on agriculture which intends to make Nigeria self-sufficient in its food security entails massive investment in both agronomy and livestock production.

‘ In view of this, MACBAN looks forward to your promise of creating a Ministry for Livestock to handle the N15 trillion Industry and its value chain.

‘ The industry stands to provide millions of quality jobs to Nigerian youth wallowing in unemployment and abject poverty which is a threat to National Cohesion and the security in the country.

‘ To achieve this objective, there is the need for immediate establishment and inauguration of the livestock implementation committee which you promised during the report presentation.’

Othman-Ngelzarma also appealed to Tinubu to allow for the stand-alone existence of the National Commission for Nomadic Educat
ion for the continued well-being of Nigerian nomads.

‘ We appreciate the efforts of security agencies in the country in combating crime but we express concern with the way and manner in which innocent pastoralists are being profiled and extorted.

‘ Yours Excellency, the hope you exude should be made a reality to strengthen the faith of ordinary Nigerians on your renewed hope agenda.

‘ We will continue to support you in your quest to strengthen institutional frameworks to make Nigeria and Nigerians the pride of Africa in innovation and productivity.’

Source: News Agency of Nigeria