Biostatistics & Methodology
Estimands, missing data, repeated measures, time-to-event methods and analysis strategy.
Insight Categories
Insights
Insights · Breast Cancer Research Month 2026 Beyond the Pink Ribbon: what breast cancer trials ask of biometrics, data and clinical development teams During Breast Cancer Research Month 2026, TUNECT shared a five-part LinkedIn series on themes that matter in…
For small and mid-sized pharmaceutical and biotech companies, “affordable clinical research” should not mean simply finding the lowest rate card. The largest savings often come from somewhere else: avoiding unnecessary complexity, reducing rework, applying controls proportionately, and using technology only…
A practical guide to CDISC standards across the clinical data lifecycle — from USDM and CDASH to SDTM, ADaM, Define-XML, controlled terminology and submission-ready metadata.
How does a CRO interact with a sponsor? What is project-based delivery, what is FSP, and what hybrid models sit between them? What do the evidence – and real delivery practice – suggest for biometrics teams? In clinical development, outsourcing…
We’re closing our E6(R3) series with two principles that most often decide whether execution stays clean: role clarity and IP/blinding traceability. 10) Roles and responsibilities (clarity + oversight) Key roles, interfaces, and responsibilities should be clearly defined and documented appropriately…
Now we move from design principles to making execution feasible and ensuring the results are reliable. 7) Risk-proportionate trial conduct (avoid unnecessary burden) Processes should be proportionate to risks to participants (including risks beyond usual care where relevant) and to…
In the last post we covered Principles 1-3 (ethics, consent, independent review). Now we move to the reliability backbone of trial evidence: science, people, and quality by design. 4) Scientifically sound trials (and periodic review) Trials should be scientifically sound…