Detective Work in Data: A Case Study in CDISC Conversion Excellence
With outdated and incomplete datasets, Veramed helped a biotech client convert its legacy clinical trial data to CDISC-compliants formats.
Delivering Cost-Efficient, Scalable FSP Solutions for a Top 10 Global Pharma
Building on a strong partnership of over a decade, Veramed’s adaptable FSP solutions enabled a global Pharma client to exceed its strategic objectives.
Q-TWiST in Oncology: A Patient-Centric View of Benefit-Risk
Introduction We help to transform complex clinical data into meaningful, patient-focused insights. In a recent post-marketing initiative, our Evidence & Value Generation (EVG) team applied the Q-TWiST methodology to evaluate a novel oncology treatment—delivering a compelling narrative around benefit-risk balance. What is Q-TWiST? Q-TWiST (Quality-adjusted Time Without Symptoms or Toxicity) is a health economics method […]
Driving Precision in Real-World Evidence: MAIC in Endometrial Cancer
Introduction We ran a complex Comparative Effectiveness project as part of the value demonstration of an immunotherapy medicine in advanced endometrial cancer. The project employed the Match-Adjusted Indirect Comparison (MAIC) methodology, guided by NICE DSU TSD 18 to ensure adherence to guidelines. This approach bridges evidence gaps where head-to-head trials are absent, supports HTA submissions […]
From Rescue to FDA Approval: Reanalysis and Resubmission of an Ophthalmology Trial
Introduction This case study highlights an ophthalmology clinical trial for a product to treat wet age-related macular degeneration (AMD). “Wet” AMD is a rare type of macular degeneration, accounting for just 10% of overall cases. However, it’s an advanced form of the condition, causing rapid onset and severe vision loss. Currently, there are very limited […]
From Setback to Success: How a Biotech transformed their Rare Disease Clinical Study by leveraging Biostatistics and Programming expertise
Introduction Rare disease studies can present unique challenges compared to other types of clinical studies. Limited patient pools and enrollment considerations are important, and the study typically has far fewer patients. These challenges can affect study design, data collection, data review throughout the trial, and how data is analyzed and presented both during and at […]
Addressing tight deadlines with automation in Phase 1/2 Biotech Trials
Recently, the Veramed team addressed the challenge of a delivery with tight timelines using automation. In this case, the team focused on automating the TFL and increasing the efficiency of Lab outputs. In clinical trials, a blind data review, also known as a dry-run, allows the statistical tables, figures and listings (TFL) to be evaluated […]
Case Study: Statistical Data Analysis Centre for a Pivotal Phase 2 Oncology Trial
Independent Data Monitoring Committees (DMC) safeguard both the interests of clinical trial participants and the integrity of the trial itself. In turn, an independent Statistical Data Analysis Centre, typically implemented by a CRO on behalf of a sponsor, fulfils a vital role in the process by providing robust, independent analyses based on instream data to […]
Supporting an Independent Data Monitoring Committee for a COVID-19 trial
Background An Independent Data Monitoring Committee (IDMC) reviews the accumulating data of an ongoing trial and monitors patient safety and treatment efficacy data. IDMCs are particularly crucial in situations where there are severe risks to patients and in studies with hospitalised populations. In this project, Veramed worked with a client developing a new therapeutic for […]
Advancing Immuno-Oncology Therapies with Expert Statistical Input
Immunotherapy represents the new frontier of cancer treatment and includes cancer vaccines, engineered T-cell therapies and T-Cell-stimulating antibodies. In essence, immunotherapies harness the defences of our bodies to combat cancer. In recent years, many biopharmaceutical companies have stepped forward into the immuno-oncology development arena. One of the most promising treatments to emerge is Merck’s Keytruda […]