28+
Years of Experiences
About Our Company
🧬 About Bottomley Consulting Group: Experts in Quality of Life, Oncology, and Clinical Trial Design:
At Bottomley Consulting Group (BCG), we specialize in supporting the pharmaceutical, biotech, and academic sectors with the strategic design and execution of clinical trials where Quality of Life (QOL) and Patient-Reported Outcomes (PROs) are key endpoints.
Founded by Dr. Andrew Bottomley, a globally recognized leader in QOL and cancer research, BCG brings over 28 years of experience to every project. Dr. Bottomley has contributed to more than 100 oncology trials, authored leading international QOL guidelines, and worked alongside regulatory agencies, HTA bodies, and global research networks.
🎯 What Sets Us Apart
All major projects are personally delivered by Dr. Bottomley—offering clients senior-level, hands-on expertise
We provide concierge-style service, tailored to your trial’s design, endpoints, and regulatory needs
Deep understanding of both scientific rigor and operational reality in multinational trials
Proven experience with tools like EORTC QLQ-C30, FACIT, PRO-CTCAE, and frameworks like SPIRIT-PRO and SISAQOL-IMI
Whether you’re launching a pivotal trial, refining endpoint strategy, or preparing for submission, BCG ensures your evidence reflects what matters most: the patient experience.
Good Business Planning Ensures Success
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Our Services
Developing Solutions For The Future
Strategy planning
Dr. Bottomley has provided consultancy services to many companies looking to develop a clear strategy for patient-reported outcome assessment.
Protocol writing
We provide expertise in protocol writing where patient reported outcomes are critical secondary or primary endpoint in your trial
Literature reviews
We are a highly experienced and knowledgeable in conducting meta-analysis, systematic and non-systematic literature reviews, as well as targeted reviews.
Using item libraries
Item libraries are a valuable new resource in the development of new Quality of Life (QOL) tools for clinical trials.
Selecting outcome measures
Selecting the most appropriate outcome tools for oncology clinical trials can be a daunting task.
Analysis of clinical trials
The analysis of QOL is a field that has often been problematic, and noted in many publications as a major shortfall for the acceptance of QOL endpoints.
Education and training
We understand the importance education and training, for all staff
Translation
High-quality translations are essential in the development and use of patient-reported outcome measures in clinical trials.
Our Mission Is Create Brand Ideas
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Working Steps
Our Basic Work Process
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Andrew was instrumental in reviewing and setting up our entire Patient-Reported Outcomes (PRO) strategy across multiple oncology trials. His guidance ensured our endpoints were fit for purpose and aligned with both regulatory and HTA expectations. The framework he helped us build has been consistently useful — not just for current studies, but as a reference model for future submissions. His strategic insight and practical approach made a real difference.
We needed help aligning our QoL endpoints across multiple indications and Andrew brought clarity and direction. His insights not only improved our protocol design, but also helped us pre-empt several regulatory questions. This was probably the smoothest interaction we've had with EMA regarding PRO justification.
Andrew provided expert guidance from the earliest stages of our trial, helping us develop a PRO strategy that was scientifically sound and aligned with FDA expectations. His involvement was critical — from initial design discussions to the final analysis plan. Over the course of more than a year, he worked closely with both our clinical and regulatory teams, ensuring our endpoints were not only measurable and meaningful but also defensible in formal FDA interactions. His deep experience, responsiveness, and ability to see the full regulatory landscape made him a trusted partner throughout.