Services -Education, Training and ethics

Empowering sites and sponsors to succeed with QOL and PRO endpoints

At Bottomley Consulting Group (BCG), we believe that effective training is essential to the success of clinical trials—especially when Patient-Reported Outcomes (PROs) or Quality of Life (QOL) endpoints are involved. Engaged, informed site staff and investigators are more likely to collect high-quality data, reduce protocol deviations, and improve patient engagement.

We provide flexible, tailored training solutions for sponsors, CROs, and site networks—ensuring teams are confident in implementing PRO protocols from day one.

📚 Our Training Services
We offer three delivery formats to suit your needs:

🧪 On-Site Training
We deliver in-person training at investigator meetings or site initiation visits, tailored to the specific needs of your trial. Sessions include:

PRO protocol walkthroughs

Practical guidance on data collection and timing

Common site-level challenges and how to overcome them

💻 Online Modules & Tools
Interactive e-learning modules covering key topics:

Selecting and validating QOL/PRO instruments

SPIRIT-PRO and CONSORT-PRO compliance

Interpreting meaningful change

Case examples from real trials

Perfect for onboarding new sites or refreshing knowledge mid-trial.

🧑‍🏫 Workshops & Webinars

Live or virtual sessions led by Dr. Bottomley and collaborators, designed for:

Trial teams

Research coordinators

Sponsors and CROs

These workshops are ideal for building internal capability and ensuring everyone—from biostatisticians to patient-facing staff—understands the why and how of PROs.

🧭 Supporting Education Through Global Standards

Our training is grounded in internationally recognized best practices. Dr. Bottomley currently serves as a board member of the PROTEUS Consortium, which supports the implementation of standardized PRO methods in trials. We also actively promote:

SPIRIT-PRO and CONSORT-PRO guidelines

Resources from the International Society for Quality of Life Research (ISOQOL)

Best practices in endpoint design, data integrity, and regulatory alignment

We routinely integrate these frameworks into our training materials—empowering sites to deliver credible, high-quality data.

🗣 Let’s Build Capacity Together
Whether you’re launching a global trial or upskilling your team on PRO strategy, Bottomley Consulting Group can provide the tools, materials, and live instruction you need to succeed.

📚 Ethics Leadership in Clinical Research

At Bottomley Consulting Group, we bring over 28 years of recognised leadership in research ethics, delivering strategic guidance and independent oversight across Europe’s most impactful clinical and academic research programmes. From 2000 to 2025, we have consistently supported the European Commission, including major initiatives such as DG Health, the European Research Council (ERC), Marie Skłodowska-Curie Actions, and the Innovative Medicines Initiative (IMI).

👨‍⚖️ Expert Leadership

Dr. Andrew Bottomley, founder of Bottomley Consulting Group, is a leading authority in research ethics—particularly in oncology, vulnerable populations, and multi-stakeholder clinical trials and more recently in AI. He has played a central role in establishing EU-wide ethical standards for research involving both adults and children across academic and industry settings.

🔍 Selected EU and International Ethics Roles

• Dual Use Advisory for LOTUS (2008–2012)

• European Commission Ethics Network Advisory Group (2008–2014)

• European Security Trends and Threats to Society (2011–2014)

• Research Ethical Committee, WHO IARC (2000–2006)

• EU-HEALTH NET (2016–2019). Lead to train EU National Contact Points in ethics to ensure future EU proposals are of high quality ethics, from clinical trials to the use of AI.

• EU DEFORM (2016–2020). Adviser on ethics in relation to all aspects of research in health care.

• EU Global Health Programme (2018–2025). Advisor to the relevant calls.

• Support-E COVID-19 Monitor – Oversight of real-world treatment studies using large-scale databases

• Trainer of National Ethics Experts – Training ethics representatives from EU Member States to support applicants in ethical proposal development

🔬 TranSYS Project: Bridging AI and Ethics in Precision Medicine

As Executive Board Member and Ethics Advisor to the TranSYS Project (2000–2024), part of the Horizon 2020 framework, Dr. Bottomley helped advance expertise, in clinical trials,  ethical and project specific AI and clinical trials in healthcare:

• Helped trained early-career researchers in clinical trials, ethics, QOL measurement, and responsible use of AI and machine learning in data-driven research

• Presented at the TranSYS Final Conference (2024, Belgrade) on the ethical and QOL implications of AI and machine learning in clinical trials

His work with TranSYS helped establish foundational standards for clinical research and use of ethical standards including the use of AI in healthcare research across Europe.

🌍 Horizon Europe & Ethics Advisory Excellence

• Vice Chair, Horizon Europe: Marie Skłodowska-Curie Actions (2024, 2025)

• Ethics Advisor, Global Health EDCTP3 Joint Undertaking – Including AI-focused global health proposals

• Ethics Advisor for Horizon Europe Calls (2023):

  • HORIZON-CL4-2023-DIGITAL-EMERGING-01

  • HORIZON-CL4-2023-HUMAN-01

  • HORIZON-CL4-2023-TWIN-TRANSITION-01

  • HORIZON-CL4-2023-RESILIENCE-01 (HaDEA Industry topics)

Dr. Bottomley has reviewed over 5000 research proposals across 40+ EU calls, helping shape the ethics standards now adopted across ERC, IMI, HaDEA, and other European funding bodies.

🤖 Ethics and Artificial Intelligence in Health Research

Dr. Bottomley is a recognised leader in the ethics and has experiences of the use of AI use in healthcare research. His contributions include:

• Ethics reviews for dozens of AI-focused proposals in diagnostics, decision-making, clinical data science, and global health

• Advising on AI governance frameworks to ensure compliance with EU standards for transparency, accountability, fairness, and human oversight

• Helping define EU-wide standards for the ethical integration of AI in Horizon Europe and EDCTP3 projects

• Supporting interdisciplinary panels to evaluate legal, ethical, and social impacts of AI technologies in health research

His work ensures that AI-enabled research is ethically sound, legally compliant, and focused on delivering real-world patient benefit.

🤝 Academic Collaborations in AI

Since 2023, Dr. Bottomley has partnered with BIO3 (Biostatistics, Biomedicine, Bioinformatics), part of the GIGA academic research center (Interdisciplinary Group of Applied Proteomics) at the University of Liège. This collaboration focuses on the GIGA-R Medical Genomics Thematic Research Unit, a group actively engaged in AI research applied to health.

This research group are involved in data mining, machine learning, parametric, semi-parametric, and non-parametric methods, as well as variable selection techniques. 

🧭 Our Services

We provide tailored ethics support for research institutions, sponsors, and EU-funded consortia, including:

• Strategic ethics advisory for EU and international clinical research

• Protocol and informed consent review, including QOL and AI components

• Governance planning and implementation of ethics oversight boards

• Ethics training workshops with emphasis on AI, real-world evidence, and oncology

• Participation in ethics panels and expert regulatory bodies

• Advisory on regulatory compliance, patient protections, and public trust

Our approach combines scientific rigour with ethical foresight, ensuring your research is not only compliant—but credible, transparent, and ethically robust.

📩 Contact Us

Want to ensure your research stands up to the highest ethical and regulatory standards?
Contact Bottomley Consulting Group to discuss how we can support your ethics strategy, training, and proposal development.