Pharmalys Ltd: Our Commitment to Quality
As an international Contract Research Organisation (CRO), Pharmalys Ltd has always been dedicated to delivering excellence in every service we provide, ensuring quality at every step. Our Business Excellence and Quality Management team is integral to all our services, meticulously defining roles and responsibilities for all stakeholders. They identify corrective and preventive actions for process improvement, write and update Standard Operating Procedures (SOPs), and conduct various audits, including investigational site facilities, study data, trial master files, and investigator site files, as well as monitoring compliance. Read more: https://www.pharmalys.com/quality-assurance/ Since 2022, Pharmalys has partnered with Qualogy 2002 Ltd, an internationally recognised accreditation scheme managed by Tim Stiles. This partnership supports organisations in implementing Good Clinical Laboratory Practice (GCLP) guidelines. These guidelines, initially produced in 2002 and co-authored by Tim Stiles, were published by the Research Quality Association and updated in December 2012. They provide essential guidance on quality systems for laboratories analysing samples from clinical trials (CTs). Widely adopted globally, GCLP guidelines are utilised by the World Health Organisation (WHO), pharmaceutical companies, research institutions, non-governmental organisations (NGOs), hospitals, CROs, and academic institutions. Partnering with Tim Stiles allows us to actively contribute to the development and expansion of the GCLP accreditation scheme, distinct from our current activities at Pharmalys. Read more: Pharmalys Ltd: Our Commitment to Quality | Pharmalys
Barriers to cancer clinical trials participation
Ongoing cancer clinical trials in Africa in 2020. From Unger J.M. et al. JNCI J Natl Cancer Inst 2019. * Circles represent individual clinical trials; colors of the circles represent the study’s primary sponsor type
The cancer clinical trials context
Clinical trials (CTs) are critical for advancing cancer research and developing new treatments that improve patient outcomes. Patient participation forms the foundation of these trials, facilitating the rapid and efficient evaluation of potential therapies. By increasing participation rates, researchers can expedite the discovery of innovative treatments, benefiting the broader cancer patient population. Moreover, CTs offer patients access to cutting-edge therapies, underscoring the importance of equitable and accessible trial opportunities for all. In the United States, cancer ranks as the second leading cause of death following heart disease [National Centre for Health Statistics, 2017]. This trend extends beyond affluent nations, affecting diverse populations worldwide. For instance, individuals of African descent, particularly those living on the continent, experience disproportionate rates of certain cancers. Compared to their counterparts in the US, incidence rates of Kaposi’s sarcoma are ten times higher, cervical cancer rates are four times higher, and liver cancer rates are significantly elevated at 24% higher. Additionally, triple-negative breast cancer affect women of African descent at higher rates, while prostate cancer outcomes are notably poorer among men of the same ethnic background. The disparity in cancer mortality rates before the age of 75 between Africa and high-development index countries (nearly doubled rates) further underscores the urgency of addressing these disparities. These disparities stem from a complex interplay of factors, including inadequate healthcare infrastructure in Africa and unique tumour genetic and biological characteristics among populations of African descent. Therefore, achieving diversity in CTs participation is crucial to ensuring that new cancer treatments are effective and safe across all patient populations. Despite the importance of inclusive participation, CTs face significant challenges in recruiting patients from diverse racial and ethnic backgrounds. Disparities persist, particularly between Caucasians and other ethnic groups, highlighting the need for targeted strategies to enhance participation rates among underrepresented populations. Read more: Barriers to cancer clinical trials participation | Pharmalys
Our Soft Skills Training Programme was a huge success!
Since 2008, Pharmalys Ltd has seen consistent growth, with a notable acceleration over the past two years, expanding from 30 to 50 employees. The Pharmalys team is primarily composed of remote workers spread across the globe, from USA to India, the UK to South Africa. This rapid expansion, coupled with increased workloads, necessitated a company reorganisation and solutions to help the team adapt to changes and embrace the new structure. To address challenges such as maintaining effective collaboration and communication, fostering team spirit and a sense of belonging, enhancing time management and motivation, we launched a comprehensive Soft Skills Programme in January 2024. Read more: Our Soft Skills Training Programme was a huge success! | Pharmalys
