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
[email protected]

GlobeNewswire Distribution ID 9146250

IEC adequately funded for elections: National Treasury


National Treasury has in a statement corrected reports on the budget allocations for the Electoral Commission (IEC) for the 2024 General Elections.

‘While budget reductions were announced in the 2024 Budget to address the country’s unsustainable debt burden, measures were taken to specifically ensure that requirements for the elections are adequately resourced,’ National Treasury said on Thursday.

As part of the 2024 Budget process, the National Treasury continuously engaged with the IEC on its funding requirements for the 2024 National and Provincial Elections.

‘The National Treasury’s engagements with the IEC confirmed that the costs related to elections can be accommodated within the entity’s baseline through surplus retention.

‘During the 2024 Medium Term Expenditure Framework (MTEF) budget process, the IEC indicated that they will not require any additional allocation for election-related activities provided that approval is granted for them to retain accumulated surpluses of R1.5 billion. This appr
oval was granted by the National Treasury.’

In the 2023/24 financial year, the Electoral Commission was allocated R2.232 billion.

The commission is allocated R2.302 billion for the 2024/25 financial year of which R322.2 million was transferred during April 2024. A further R1.040 billion is being transferred between May and June 2024 to the commission.

‘Assertions in the media about the budget baseline trends of the Electoral Commission reflect an incomplete reading of the Budget documentation and a misunderstanding of both the budget process and the nature of the challenges faced by the IEC and experienced by voters during Election Day,’ National Treasury said.

The 2024 Budget Review outlined these measures, including:

Reversing spending reductions to the IEC, making an additional R250 million available compared to the 2023 MTBPS estimates;

Allowing the IEC to retain its accumulated surpluses of R1.5 billion; and

New additional allocations of R350 million for the security of the election process.

Sou
rce: South African Government News Agency

HSRC survey finds trust in IEC by voters was high


A Human Sciences Research Council (HSRC) survey has found that trust in the Electoral Commission of South Africa (IEC) was high among voters, as millions cast their vote in the National and Provincial Elections (NPE) on Wednesday, 29 May.

This is according to the HSRC’s preliminary findings on the survey conducted on Election Day, as South Africans voted, marking 30 years since the historic first democratic elections in 1994.

The HSRC released its preliminary findings at the IEC national Results Operations Centre (ROC) in Midrand on Friday.

In the Election Satisfaction Survey (ESS), voters were asked questions about the election process, including whether the 2024 NPE were free and fair.

The survey aimed to establish the opinions and perceptions of voters and their electoral experience.

The research sampled 300 voting stations selected countrywide, proportional to race, geographic type and the number of voting stations in each province.

‘Trust in the Electoral Commission was high and almost all voters
felt that they were safe to cast their ballot in secrecy,’ the survey found.

According to the HSRC’s Dr Benjamin Roberts, trust in the country’s election management body is well in the 80% rate.

‘The trust in the commission remains dominant… Amongst the general public, trust in the commission has been declining, as it has in all core political institutions over the last decade and a half, although the IEC remains among the trusted institutions in the country.

‘But obviously, the voting public trust is much higher.’

Roberts believes that this is predominantly because those who had a positive experience leaving the aspect of the queuing time translates to the validation of the institution.

‘The other reason is that for many South Africans, the predominant response to unhappiness with the function of the political system is the abstention and not electoral turnout. We’re finding increasing polarisation of happier voters and discontent and abstinence. That’s what’s probably driving the positive evaluations,’
said Roberts.

Meanwhile, results indicated that voters overwhelmingly believed the 2024 NPE were free and fair and positively rated the conduct of officials at voting stations.

‘Almost all voters felt that they were safe to cast their ballot in secrecy,’ said Roberts.

The majority of voters also felt that the IEC adequately considered the needs of vulnerable groups, including the elderly and people with disabilities.

However, the finding showed that queuing times at voting stations increased relative to more recent elections, which had a bearing on electoral evaluations.

In addition, most voters were pleased with the ballot papers, with 58% indicating they were ‘very satisfied’ and 35% told researchers they were ‘satisfied’.

However, 38% wanted to improve the ballot paper for future elections.

In addition, fewer people believe that their vote counts than those who believe they must vote.

Coercion and availability of information

Shifting focus to coercion, 12% reported experiencing someone trying to f
orce them to vote for a certain political party or candidate, while nine percent said it happened before Election Day.

Four percent said they were forced by party agents and four percent by friends and family.

‘Of those reporting coercion, 73% reported that it had no bearing on electoral choice, 25% said it did and two percent uncertain. This translates into three percent of all voters who changed their vote,’ Roberts said.

On the level of information, roughly 13% stated that they had far too little information and 10% said they had too little information about the voting procedures.

Meanwhile, 42% said that the IEC website was ‘very useful’ in providing information and education and 23% said ‘somewhat useful’.

According to the survey, 52% said that the IEC voter education campaigns were ‘very useful’ in providing information and education and 28% said ‘somewhat useful’. – SAnews.gov.za

Source: South African Government News Agency

HSRC survey finds trust in IEC by voters was high


A Human Sciences Research Council (HSRC) survey has found that trust in the Electoral Commission of South Africa (IEC) was high among voters, as millions cast their vote in the National and Provincial Elections (NPE) on Wednesday, 29 May.

This is according to the HSRC’s preliminary findings on the survey conducted on Election Day, as South Africans voted, marking 30 years since the historic first democratic elections in 1994.

The HSRC released its preliminary findings at the IEC national Results Operations Centre (ROC) in Midrand on Friday.

In the Election Satisfaction Survey (ESS), voters were asked questions about the election process, including whether the 2024 NPE were free and fair.

The survey aimed to establish the opinions and perceptions of voters and their electoral experience.

The research sampled 300 voting stations selected countrywide, proportional to race, geographic type and the number of voting stations in each province.

‘Trust in the Electoral Commission was high and almost all voters
felt that they were safe to cast their ballot in secrecy,’ the survey found.

According to the HSRC’s Dr Benjamin Roberts, trust in the country’s election management body is well in the 80% rate.

‘The trust in the commission remains dominant… Amongst the general public, trust in the commission has been declining, as it has in all core political institutions over the last decade and a half, although the IEC remains among the trusted institutions in the country.

‘But obviously, the voting public trust is much higher.’

Roberts believes that this is predominantly because those who had a positive experience leaving the aspect of the queuing time translates to the validation of the institution.

‘The other reason is that for many South Africans, the predominant response to unhappiness with the function of the political system is the abstention and not electoral turnout. We’re finding increasing polarisation of happier voters and discontent and abstinence. That’s what’s probably driving the positive evaluations,’
said Roberts.

Meanwhile, results indicated that voters overwhelmingly believed the 2024 NPE were free and fair and positively rated the conduct of officials at voting stations.

‘Almost all voters felt that they were safe to cast their ballot in secrecy,’ said Roberts.

The majority of voters also felt that the IEC adequately considered the needs of vulnerable groups, including the elderly and people with disabilities.

However, the finding showed that queuing times at voting stations increased relative to more recent elections, which had a bearing on electoral evaluations.

In addition, most voters were pleased with the ballot papers, with 58% indicating they were ‘very satisfied’ and 35% told researchers they were ‘satisfied’.

However, 38% wanted to improve the ballot paper for future elections.

In addition, fewer people believe that their vote counts than those who believe they must vote.

Coercion and availability of information

Shifting focus to coercion, 12% reported experiencing someone trying to f
orce them to vote for a certain political party or candidate, while nine percent said it happened before Election Day.

Four percent said they were forced by party agents and four percent by friends and family.

‘Of those reporting coercion, 73% reported that it had no bearing on electoral choice, 25% said it did and two percent uncertain. This translates into three percent of all voters who changed their vote,’ Roberts said.

On the level of information, roughly 13% stated that they had far too little information and 10% said they had too little information about the voting procedures.

Meanwhile, 42% said that the IEC website was ‘very useful’ in providing information and education and 23% said ‘somewhat useful’.

According to the survey, 52% said that the IEC voter education campaigns were ‘very useful’ in providing information and education and 28% said ‘somewhat useful’. – SAnews.gov.za

Source: South African Government News Agency