Clinical & Methodological Support for Cancer and Non-cancer PCP

We offer potential partners the expertise of a multidisciplinary team supporting PCP projects in oncology and non-oncological diseases, with particular strength in translating clinical needs into measurable requirements, validation frameworks, and implementation evidence. Our contribution is positioned on the buyer/clinical-expert side, supporting hospitals, cancer centres, and public procurers in defining unmet needs and evaluating innovative solutions.

Clinical needs: Through collaboration with internal medicine, urology, neurosurgery/neuro-oncology and gynaecological oncology teams, we can support structured identification of unmet clinical needs within these fields of interest. We can translate patient pathways, diagnostic or therapeutic bottlenecks and clinician requirements into use cases, target populations, functional specifications and measurable performance criteria for PCP solutions.

Multicentre validation and study design: We provide expertise in investigator-initiated and multicentre clinical studies, including study design, endpoint selection, power and sample-size calculations, randomisation, Statistical Analysis Plans, missing-data strategies, subgroup analyses and interpretation of outcomes. These capabilities can support comparative pilots and multicentre validation across participating procurers and healthcare systems.

Clinical, molecular and biomarker validation: We combine clinical data analysis with transcriptomics, single-cell genomics, systems biology and biomarker research. We can assess diagnostic, prognostic, and predictive performance; integrate molecular and clinical variables; define reference standards; and evaluate added value beyond routine clinical information. Representative work includes transcriptomic markers stratifying biochemical recurrence in prostate cancer (PMID: 37176106), Notch-related stratification of prostate cancer aggressiveness (PMID: 36613607), and a workflow enabling single-nucleus RNA-seq from radical prostatectomy specimens (PMID: 42297938).

Biostatistics, XAI and performance evaluation: We can establish statistical validation frameworks for candidate technologies, including predefined performance metrics, discrimination, calibration, sensitivity/specificity, longitudinal outcomes, robustness and subgroup analyses. Our expertise includes multivariable modelling, machine learning and AI/XAI-supported interpretation. We also developed a computational approach for survival-based optimisation of continuous biomarkers (PMID: 31319941).

Real-world evidence, data quality and GCP: We have experience with heterogeneous clinical datasets and non-commercial clinical studies and can contribute to RWD analysis, data-quality frameworks, endpoint harmonisation and reproducible statistical reporting. Our expertise includes GCP compliance, data integrity, database closure and methodological oversight, supporting evidence generation under real healthcare conditions (e.g. PMID: 41238080**)**.

Patient pathway and clinical utility: We can evaluate how a technology would fit into existing diagnostic or treatment pathways, which patient group would benefit, what clinical decision it should change and which outcomes should demonstrate value. This includes feasibility, workflow impact and implementation requirements across centres with different resources.

HTA, Health Economics and system impact: Our profile is complemented by an MBA in Healthcare Management with training in health economics and Health Technology Assessment. We can support early assessment of clinical utility, resource use, implementation barriers, scalability and potential cost-effectiveness, helping procurers assess affordability and sustainability alongside technical performance.

Innovation translation: Our previous molecular and clinical research may provide clinically grounded use cases for future PCP actions, for example, decision-support or diagnostic solutions for aggressive or recurrent cancers. Our role would be to define the unmet need, clinical specifications and validation criteria rather than conduct discovery research within the PCP. Competitive suppliers could then develop and test solutions responding to these requirements.

Partnership sought: We may collaborate with hospitals, Comprehensive Cancer Centres, and other eligible public procurers, building a buyers group, as well as PCP-methodology, procurement, regulatory, HTA, and patient-engagement experts. We can contribute as a clinical-methodological and evidence-generation partner from needs definition and common specifications through pilot validation and implementation-oriented assessment.

Together, these capabilities position us as a support team for PCP consortia, bridging clinicians, public procurers, biomarker science, data analysis, biostatistics and health-economics assessment to ensure that procured cancer innovations are clinically relevant, measurable, affordable and implementable.