Resource Library
Explore practical guidance, expert perspectives and evidence-led resources covering clinical research, biometrics and trial delivery.
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Whitepaper Volume II – Process Debt: The Hidden Cost of Scaling Without Process Redesign
As CDM organisations scale, hidden operational pressures accumulate beneath successful delivery — until they affect quality, timelines and workforce sustainability. Volume II reveals the risks of scaling without process redesign.
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Whitepaper Volume I – Sustainable Scale: Designing People-Centric Operating Models for Complex Trials
As Clinical Data Management grows more complex, many organisations are asked to scale faster than their operating models allow. Volume I explores people-centric operating models built for complexity, accountability and resilience.
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Whitepaper The Ethics of AI in Medical Writing
As AI transforms medical writing, teams must adopt new tools without sacrificing scientific accuracy or regulatory compliance. This paper weighs innovation against ethical responsibility and the need for expert human oversight.
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Whitepaper A Biotech Leader's Guide to Success
In early clinical development, data is the product — success depends on how fast and credibly it's generated. How sponsor-owned data strategies align collection with analysis while protecting quality.
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Whitepaper Beyond Traditional Outsourcing: The Data Science CRO Advantage
As clinical trials grow more complex, sponsors are turning to a specialised model of outsourcing — the data science CRO — to optimise operations, control cost and protect quality across their studies.
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Case Study Rescue Services: A Pivotal Phase III Study in Oncology
Metronomia rescued a delayed Phase III oncology study by automating data transfers, strengthening cleaning and reconciliation and streamlining the pipeline — restoring confidence in the outcome and winning further collaboration.
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Whitepaper Clinical Data Management and Statistical Rescue Services in Clinical Trials
How rescue services turn around underperforming trials: when to engage a data science CRO, best practices for recovery, and the capabilities needed to resolve delays, cost overruns and regulatory risk.
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Case Study ISS/ISE Package in Immunology
Metronomia prepared an Integrated Summary of Safety and Efficacy by integrating data from 11 heterogeneous trials — five with legacy formats — standardising formats and harmonising endpoints for submission.
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Whitepaper Benefits of Bayesian Optimal Interval (BOIN) Design for Early-phase Oncology Trials
Early-phase oncology trials must find the maximum tolerated dose safely. This paper compares the traditional 3+3 with the Bayesian Optimal Interval (BOIN) design and its advantages in flexibility and efficiency.
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Case Study Rescue Services: A Global Phase II Study in Dermatology
Metronomia took over Clinical Data Management and Biostatistics for a global Phase II dermatology study after deficiencies in the previous CRO's performance, stabilising delivery and timelines.
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Whitepaper Sample Size Calculations – Practical Guidance Beyond the Formulae
How many patients are enough? Behind every sample size lies a set of assumptions about treatment effect, variability, risk and feasibility — a practitioner's guide to the real-world trade-offs beyond the formulae.
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Case Study Driving Innovation: The Metronomia–Medidata Partnership
How the Medidata partnership gives Metronomia the tools and expertise to deliver excellence for customers across EDC and clinical data workflows.
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Whitepaper An Introduction to Clinical Data Warehousing
With clinical trial data volumes growing and reporting demands rising, this paper sets out the core design principles and use cases for clinical data warehouses — architecture, integration, bi-directional data flow and vendor considerations.
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Publication A multicenter phase 1 study of solitomab (MT110, AMG 110), a bispecific EpCAM/CD3 T-cell engager (BiTE) antibody construct, in patients with refractory solid tumors
Multicentre Phase 1 study of the bispecific EpCAM/CD3 BiTE solitomab in refractory solid tumours.
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Anti-C5a antibody IFX-1 treatment versus best supportive care for patients with severe COVID-19
Trial comparing anti-C5a antibody IFX-1 with best supportive care in patients with severe COVID-19.
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Assessing health-related quality of life in patients with Parkinson's disease in a prospective longitudinal study
Prospective longitudinal assessment of health-related quality of life in Parkinson's disease.
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Bispecific T-cell engager (BiTE) antibody construct blinatumomab for the treatment of patients with relapsed/refractory non-Hodgkin lymphoma: final results from a phase I study
Final Phase I results for the BiTE construct blinatumomab in relapsed/refractory non-Hodgkin lymphoma.
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Cabergoline versus levodopa monotherapy: a decision analysis
Decision-analytic comparison of cabergoline versus levodopa monotherapy in Parkinson's disease.
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Cost of illness and its predictors for Parkinson's disease in Germany
Cost-of-illness study and predictors for Parkinson's disease in Germany.
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Cost of illness in Parkinson disease. A retrospective 3-month analysis of direct costs
Retrospective 3-month cost-of-illness analysis of direct costs in Parkinson's disease.
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Costs of drug treatment of neurologic diseases: Parkinson disease, dystonia, epilepsy
Analysis of drug-treatment costs across Parkinson disease, dystonia and epilepsy.
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Costs of treating dystonias and hemifacial spasm with botulinum toxin A
Cost analysis of treating dystonias and hemifacial spasm with botulinum toxin A.
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Economic evaluation of maintenance treatment with tacrolimus 0.1% ointment in adults with moderate to severe atopic dermatitis
Economic evaluation of maintenance tacrolimus 0.1% ointment in adults with moderate-to-severe atopic dermatitis.
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Expression of epithelial cellular adhesion molecule (Ep-CAM) in chronic (necro-)inflammatory liver diseases and hepatocellular carcinoma
Study of Ep-CAM expression in chronic inflammatory liver disease and hepatocellular carcinoma.
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Long-term follow-up of hematologic relapse-free survival in a phase 2 study of blinatumomab in patients with MRD in B-lineage ALL
Long-term haematologic relapse-free survival follow-up from a Phase 2 study of blinatumomab in B-lineage ALL with MRD.
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Long-term follow-up of serum immunoglobulin levels in blinatumomab-treated patients with minimal residual disease-positive B-precursor acute lymphoblastic leukemia
Long-term follow-up of serum immunoglobulin levels in blinatumomab-treated MRD-positive B-precursor ALL patients.
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Long-term relapse-free survival in a phase 2 study of blinatumomab for the treatment of patients with minimal residual disease in B-lineage acute lymphoblastic leukemia
Phase 2 study reporting long-term relapse-free survival with blinatumomab in MRD-positive B-lineage ALL.
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Phase II trial of the anti-CD19 bispecific T cell-engager blinatumomab shows hematologic and molecular remissions in patients with relapsed or refractory B-precursor acute lymphoblastic leukemia
Phase II trial of blinatumomab showing haematologic and molecular remissions in relapsed/refractory B-precursor ALL.
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Principles and recommendations for incorporating estimands into clinical study protocol templates
Practical principles and recommendations for embedding the ICH E9(R1) estimand framework into protocol templates.
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Prophylaxis of migraine with oral magnesium: results from a prospective, multi-center, placebo-controlled and double-blind randomized study
Prospective, multicentre, placebo-controlled, double-blind RCT of oral magnesium for migraine prophylaxis.
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SAE reporting in EDC trials
Practical perspectives on serious adverse event reporting within EDC-based clinical trials.
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Strong dose response after immunotherapy with PQ Grass using conjunctival provocation testing
Dose-response findings after PQ Grass immunotherapy assessed by conjunctival provocation testing.
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Targeted therapy with the T-cell-engaging antibody blinatumomab of chemotherapy-refractory minimal residual disease in B-lineage acute lymphoblastic leukemia patients results in high response rate and prolonged leukemia-free survival
Blinatumomab in chemotherapy-refractory MRD B-lineage ALL, showing high response rates and prolonged leukaemia-free survival.
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The anti-C5a antibody vilobelimab efficiently inhibits C5a in patients with severe COVID-19
Pharmacodynamic evidence that vilobelimab efficiently inhibits C5a in patients with severe COVID-19.
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The economic impact of Parkinson's disease. An estimation based on a 3-month prospective analysis
Estimation of the economic impact of Parkinson's disease from a 3-month prospective analysis.
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Twice-weekly treatment with tacrolimus 0.03% ointment in children with atopic dermatitis: clinical efficacy and economic impact over 12 months
Clinical efficacy and 12-month economic impact of twice-weekly tacrolimus 0.03% ointment in children with atopic dermatitis.
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Vaccinations in recurrent urinary tract infections — an observation study relating to health economy
Observational health-economics study of vaccination in recurrent urinary tract infections.
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Validation of a menstrual pictogram and a daily bleeding diary for assessment of uterine fibroid treatment efficacy in clinical studies
Validation of a menstrual pictogram and daily bleeding diary as efficacy measures in uterine fibroid treatment studies.
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Vilobelimab in combination with tocilizumab or baricitinib dramatically improves mortality in critically ill COVID-19 patients: a subgroup analysis
Subgroup analysis of vilobelimab combined with tocilizumab or baricitinib in critically ill COVID-19 patients.
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Randomized controlled trials define shape of dose response for Pollinex Quattro Birch allergoid immunotherapy
RCTs characterising the dose-response relationship for Pollinex Quattro Birch allergoid immunotherapy.
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Vilobelimab in combination with tocilizumab may synergistically improve mortality in critically ill COVID-19 patients: a post-hoc analysis of the Phase III PANAMO study
Post-hoc analysis of the Phase III PANAMO study examining vilobelimab combined with tocilizumab in critically ill COVID-19 patients.
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Anti-C5a antibody (vilobelimab) therapy for critically ill, invasively mechanically ventilated patients with COVID-19 (PANAMO): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial
The pivotal multicentre, double-blind, randomised, placebo-controlled Phase 3 PANAMO trial of vilobelimab in mechanically ventilated COVID-19 patients.
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