Biomapas Bulletin – Seventh Edition
Happy Friday and welcome back! This month, we start by diving into key industry updates on new WHO and FDA clinical trial guidelines, along with some exciting news from ClinicalTrials.EU
In our Insightful Reads section, we explore how streamlining Medical Information and Pharmacovigilance processes boost operational efficiency, discover key insights on diversity in clinical trials from our CEO, along with a recent article outlining essential considerations for ensuring patient safety.
We delve into key takeaways from the DIA Medical Information & Communications Conference, and a snippet from the TOPRA Annual Symposium. Lastly, a quick recap of Biomapas’s internal life, including the inspiring Rimi Vilnius Marathon, and CEO Award. So, without further ado, let’s get into it!
Industry news round-up
The World Health Organisation (WHO) has released new guidelines to improve the design, conduct and oversight of clinical trials in countries of all income levels, promoting equitable access to health interventions. This guidance addresses challenges such as poor trial design, limited participant diversity, and infrastructure inefficiencies. Developed through a broad consultation process, the recommendations focus on improving R&D ecosystems and fostering community engagement to build trust in health innovations.
The U.S. Food and Drug Administration (FDA) has released draft guidance, which once finalised, will provide recommendations to sponsors for conducting multiregional clinical trials (MRCTs) in oncology. The document aims to improve the design, conduct, and analysis of MRCTs, ensuring that data generated from oncology studies are relevant to U.S. patients and medical practices. In addition, due to concerns over a decrease in U.S. participation in such trials, the guidance aims to enhance the generalisability of trial results to the U.S. population.
The European Clinical Trials Information Network (ClinicaTrials.EU)?announced its launch across Europe to streamline clinical trial recruitment. The organisation addresses recruitment inefficiencies of suitable patients in the current European landscape, with 80% of trials lacking insufficient patient samples, and 86% of patients not being captured by traditional trial methods. The platform, available in multiple languages, uses an AI-driven pre-screening tool to connect patients with trials in their region, aiming to empower patients to self-select trials and to improve recruitment speed and cost-efficiency for sponsors.
Insightful Reads
Streamlining Medical Information & Pharmacovigilance Processes for Operational Efficiency through a Unified Solution Developed by Nexentria?
Integrated Pharmacovigilance (PV) and Medical Information (MI) activities facilitate patient safety monitoring, regulatory compliance, and operational efficiency. Utilising a Single Source of Truth (SSOT) framework enables seamless data aggregation and analysis, allowing pharma companies and their Service Providers to identify trends in a timely manner. In addition to promptly responding to inquiries from healthcare professionals and patients regarding product safety and efficacy, thereby fostering transparency and accountability.?
Partnering with technology provider Nexentria, we developed a cloud-based, omnichannel intake database for the end-to-end management of Medical inquiries, Adverse Events (AEs), Medical Device Incidents (MDIs) and Product Quality Complaints (PQCs) intake and handling, aimed at streamlining operational processes and ensuring sustainability. A comprehensive evaluation revealed the need to centralise MI and PV activities to address inconsistent practices across local and global teams and diminish risks.?
Solution Implementation?
The core objective was to create a single interface to handle data intake and management from various sources. This new system automatically documents incoming data, actions, and decisions, eliminating the reliance on external tools such as call centres, share points, mailboxes or separate content management systems (CMS). By integrating a task manager, we enhanced the tracking of follow-up attempts, quality checks, and data entry accuracy – all within one platform.?
User Acceptance Testing validated the system’s usability and effectiveness. Transitioning to the new platform involved harmonising PV/MI/QA standard operating procedures and providing extensive training to ensure smooth implementation.?
Benefits of an Integrated Solution for Omnichannel Intake and Management?
Implementing a unified interface for the intake and management of MI inquiries, AEs, MDIs, and PQCs has significantly improved both internal and external efficiencies. Notable outcomes from this deployment include:?
The Bottomline?
As the complexity of medical therapies and personalised medicines grows, so does the need for efficient MI and PV safety data management. Our collaboration with Nexentria has resulted in a robust, integrated database solution for the effective management of MI, AEs, MDIs and PQCs.??
This integrated approach not only enhances operational efficiency but also ensures that pharmaceutical companies can respond effectively to the dynamic challenges of the healthcare environment.??
Interested to learn more about optimising MI and PV processes? Read our whitepaper at: Whitepaper Operational Efficiency in Pharmacovigilance & Medical Information Processes - Biomapas
About Nexentria?
Nexentria is a tech provider focused on Pharma Industry solutions offering En3, an AI-powered platform designed for managing MI, AEs, MDIs and PQCs across channels. Developed by MI experts, it offers an all-in-one solution with features like integrated telephony, task management, and an AI co-pilot. The platform improves efficiency by centralising inquiries, tasks, and follow-ups, providing actionable insights through advanced analytics. Through an intuitive interface, Nexentria ensures rapid onboarding, while its automation tools help users reclaim time and reduce operating costs.?
Diversity in Clinical Trials: Significance & Challenges
Diversity in clinical research is essential for uncovering critical insights and developing treatments that benefit all populations effectively. Ensuring equitable access for everyone, regardless of their background or socioeconomic status, is key to achieving this goal. However, overcoming the obstacles requires targeted strategies, clear guidelines, and collaboration on a global level.
In a recent article, János Filakovsky , CEO of Biomapas, explores the critical importance of diversity in clinical trials and its impact on treatment development. He discusses key challenges such as socioeconomic barriers, logistical difficulties, and healthcare mistrust while emphasising the need for inclusive trial designs that adhere to FDA and EMA guidelines.
Additionally, the article examines the ethical and practical implications of involving diverse participants, ensuring research findings are broadly applicable and preventing potential harm to underrepresented groups.
Discover more about diversity and its role in shaping clinical trials: Diversity in Clinical Trials: Significance & Challenges - Biomapas.
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Improving Patient Safety in Clinical Trials – The role of CROs
In September, we celebrated World Patient Safety Day by highlighting effective approaches to improving safety in clinical trials.
Early risk identification and management are crucial for protecting patient well-being throughout the trial process, and CROs play a key role in utilising advanced technologies and implementing strategic measures to guarantee safety throughout the trial process.
Discover the essential elements that ensure patient safety in clinical trials in our latest article: (25) Improving Patient Safety in Clinical Trials - The Role of CROs | LinkedIn
Global Engagements
Our colleagues have started their globe-trotting journey in rainy London this season at DIA MedInfo, heading to the port city of Rotterdam for the TOPRA Symposium not long after. Dive into their takeaways below:
Reflecting on DIA Medical Information and Communication Conference – London, UK
Besides getting a nice feel of the autumn in the British Capital, our Biomapas team gathered valuable insights from this year’s DIA conference. Here are some key highlights and takeaways from Olga Asimaki, PhD, CMD , Head of Global Medical Information/International QPPV, Roberta Scicchitano , MI Project Manager, and Deni Christov , Business Development Manager:
At the DIA MedInfo conference, the importance of partnership is the main focus, with service providers and biopharma working as one team in outsourcing. It is without doubt one of the most interactive events out there, including lively audience participation and engaging discussions after every presentation. We can’t wait to be back!
Snippet from TOPRA Annual Symposium – Rotterdam, Netherlands
TOPRA may have wrapped up a couple of days ago, but our Biomapas colleagues are still on high energy.
Regulatory experts, Eleni Chatziieremia and Florina R?peanu , along with Business Development Director, Marco Della Mura , had great opportunities to reconnect with existing partners, forge new connections, and introduce Biomapas’s solutions to potential collaborators.
Some key regulatory topics discussed this year included the fast-growing role of AI and automation tools, recent regulations in IVD medical devices, and strategies around competitor intelligence. Look out for their reflections and highlights on the conference next week!
Upcoming Events & Conferences
World Drug Safety Congress Europe – 9th - 10th October in Amsterdam, Netherlands
7th Annual Clinical Trials Outsourcing DACH 2024 – 29th - 30th October in Zurich, Switzerland
We would love to connect with you, so if you will be attending these events or simply want to learn more about our pharmacovigilance, medical information, clinical and regulatory services, start a conversation at: Contact Us (biomapas.com)
Biomapas’s Lively Internal Initiatives
Pushing our Limits at Vilnius Marathon
Even as the autumn leaves sweep through Europe, we are not ready to put away those running shoes just yet. This September many of our colleagues pushed themselves above their limits?on the Rimi Vilnius Marathon, covering distances between 5 – 42 km. We couldn’t be more inspired by their strength and resilience!
Taking on this?fantastic event is just one of our corporate social responsibility initiatives?to foster?both physical and physiological well-being at Biomapas. Spending the day with our colleagues from different departments and cheering each other on while on the road, was truly an exciting journey!
Interested in joining the team? You can find our open opportunities here: Careers (biomapas.com)
Reward & Recognition Programme
Being recognised for one’s hard work and achievements is always rewarding but celebrating it over lunch at the Biomapas HQ takes it to the next level! Recently, our CEO, János Filakovsky, had the pleasure of hosting a special lunch to honour our Platinum Award winner, Artemis Thanasopoulou, Deputy International QPPV.
The Platinum Award, presented by the CEO, is the greatest honour for exceptional performance for those?driving improvements within the organisation, as part of our Reward & Recognition programme. As a token of our appreciation Artemis was awarded a trip to Kaunas, Lithuania, where over a delicious meal, she and János?discussed several key topics essential to our continued growth and success.
To learn more about our company culture, visit: About Us (biomapas.com)
Thank you for being part of our journey, we are excited to share more updates, insights, and exciting developments – until next time, we keep innovating, collaborating, and making a positive impact in the world of healthcare!