Strategies for the future of clinical research: decentralised clinical trials
Challenges with traditional clinical trials
The traditional clinical trials system acts as a quality funnel for the development and implementation of new drugs, devices and health system interventions. They are centred around the trial site(s). The trial protocols tend to be increasingly complex, and regulatory and safety requirements mandate frequent site visits at all stages of the trial, namely screening, counselling, consenting, administration of interventions, outcome assessment, and follow-up. As a result, patients are often required to visit the site to complete trial-related processes, while the infrastructure and staffing demands of these sites consume significant resources. Consequently, such research sites are typically established within larger medical institutions, which may be located far from the participants’ residence. Traditional clinical trials encounter various challenges that can impede efficient conduct of research, such as operational inefficiencies in participant identification, recruitment, data acquisition, and follow-up. These challenges can inflate costs, increase participant burden, and prolong an already lengthy trial timeline, all of which contribute to low clinical trial participation. In addition, individuals living at a distance from research sites or those facing mobility or scheduling constraints may find participation financially burdensome or logistically unfeasible, thereby expanding disparities in research access and limiting participant diversity. For instance, a 2019 systematic review revealed that only around 8% of cancer patients in the United States enroll in cancer trials. Decentralised clinical trials were introduced several years ago to decentralise the conduct of a clinical trial, bringing certain procedures closer to the participants’ homes for enhanced convenience (participant-centric approach). Read more: https://www.pharmalys.com/strategies-for-the-future-of-clinical-research-decentralised-clinical-trials/
Five reasons why we should invest in women-owned businesses
In the pursuit of inclusive economic growth, one of the most important avenues to explore is the support of women-owned businesses. Across the globe, women entrepreneurs are not just contributors to economies, they are agents of change, driving innovation, creating jobs, and fostering resilient communities.
About Pharmalys: A women-owned clinical research organisation (CRO)
At Pharmalys, we are incredibly proud to be a woman-owned organisation. Our CEO and founder, Marieme Ba, is a Senegalese entrepreneur and scientist who founded the CRO with a strong commitment to improving health research through data excellence. Marieme’s story of success as a female entrepreneur is a testament to the importance of women-owned enterprises in driving positive change, particularly in underserved communities. Pharmalys was founded in 2008 in London. Marieme understood the critical role that data plays in shaping healthcare policies, driving research initiatives, and ultimately, saving lives. One of Pharmalys’ key strengths lies in its unwavering commitment to Africa. Recognising the potential for progress on the continent, Marieme expanded the organisation’s reach, establishing a regional office in Dakar, Senegal, in 2012 which positioned the company as a leader in advancing health research and data analytics across the continent. Many years later, Pharmalys consists of a diverse team of experts, drawing talent from across the globe to form an international team fuelled by expertise with a shared mission to Count Africa In to clinical research. Read more: https://www.pharmalys.com/
Five reasons why we should invest in women-owned businesses
A recent study across Kenya and Nigeria shed light on the aspirations and challenges faced by women entrepreneurs, underscoring the urgent need for investment in their ventures. The survey included over 200,000 women, revealing a common aspiration among them all; the desire to own or expand their own businesses. Read more: https://www.pharmalys.com/five-reasons-why-we-should-invest-in-women-owned-businesses/
Arthur Makadi, Strategic Projects Coordinator, shares his experience since joining the Pharmalys team
In April 2024, I embarked on a pivotal journey as the Strategic Projects Coordinator at Pharmalys, an organisation recognised for its commitment to advancing global health through clinical research conducted in adherence to international guidelines and high-quality standards.
Joining Pharmalys was not just a career move but a strategic decision aligned with my professional ethos and commitment to elevating clinical research standards worldwide. Since its inception in 2008, Pharmalys has significantly increased its expertise in research projects and expanded collaborations across Europe and Africa. The company has worked with various organisations, including pharmaceutical companies, non-governmental organisations, and institutional structures, cultivating strong professional ties with Key Opinion Leaders, Principal Investigators, and clinical research site staff. Pharmalys’ vision of ‘a world free of unnecessary suffering due to unmet health care needs’ profoundly resonates with my personal and professional ideals, motivating me to make meaningful contributions to this cause.
The digital transformation of healthcare is reshaping how systems operate, creating both opportunities and challenges for equitable health outcomes. In response, the World Health Organisation (WHO) has launched the Strategic Partnership for Data and Digital Health, a...
The recent revision of the Declaration of Helsinki, adopted at the 2024 General Assembly of the World Medical Association (WMA) in Helsinki, represents a pivotal moment in the evolution of ethical standards for medical research involving human participants. This...
Implementation research: what is it about and what is its value? A free webinar by Pharmalys Ltd, CREDO Institutional Sponsor 28 November 2024 13:00-15:00 Greenwich Mean Time Panellists: Piero Olliaro, Prof. of poverty related infectious diseases,...
October marks Breast Cancer Awareness Month, a time to reflect on the impact breast cancer has on millions of women worldwide and to reaffirm our commitment to supporting the cause. As a clinical research organisation involved in maternal and child health, Pharmalys...
The PostAcute Sequelae of SARSCoV-2 (PASC) The COVID-19 pandemic has caused widespread devastation, with the immediate and short-term effects of SARS-CoV-2 infection now well described. While most people recover, many experience longer-lasting effects known as long...
EU-Africa PerMed (Building Links Between Europe and Africa in Personalised* Medicine) is an international project funded by the European Commission’s Horizon 2020 programme. Its goal is to integrate more African countries into the global Precision Medicine (PM)...
The clinical trial landscape has undergone significant changes since the concept of trials was first introduced, with notable shifts in the social, ethical, and regulatory environments worldwide. The Clinical Trial Landscape Is Evolving Today, there is a broader...
Figure 1. Number of clinical trials by year, country, WHO region and income group (1999-2022). Source: World Health Organisation (February 2023). The global landscape of clinical research (CR) has experienced substantial growth, with thousands of clinical...
In recent years, the global landscape of clinical research (CR) has been evolving, with Africa emerging as a vital player in this field. Despite being home to a wealth of diverse populations and disease burdens, the continent remains underrepresented in clinical...
A Year of Growth and Discovery: Reflections from a Clinical Project Manager at Pharmalys Ltd Pharmalys Ltd is a regional Contract Research Organisation (CRO) that has seen significant growth over the past three years. Headquartered in Europe with regional offices in...
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