How to avoid mistakes when using eTMFs
Adopting an electronic Trial Master File (eTMF) is a key step towards more efficient, compliant clinical trials. But moving from paper to digital isn’t as simple as uploading files and […]
How digital tools reduce paperwork in clinical trials
Clinical trials generate a tremendous amount of documentation, from patient consent forms and visit logs to adverse event reports and regulatory submissions. Traditionally, all of this has been managed on […]
What should be in your first ePRO form?
When starting a clinical trial, patient data is everything. But how you collect that data can make or break the success of your study. Electronic Patient-Reported Outcomes (ePRO) have become […]
Managing budgets and invoicing in clinical trials: why you need a CTMS
Clinical trials are complex by nature, scientifically, operationally, and financially. While much attention is given to data collection and patient safety, one critical element often underestimated is the management of […]
From ethics committees to digital platforms: modernising ethical oversight in clinical trials
Ethics committees, known globally as Institutional Review Boards (IRBs), Research Ethics Committees (RECs) or similar, are the cornerstone of clinical trial integrity. Their work ensures that research is conducted ethically, […]
Regulatory readiness: How to keep your trial systems inspection-ready 24/7
In clinical research, inspections are not a matter of if, they are a matter of when. Regulatory authorities such as the EMA and the FDA can request access to your […]
Who Owns the Data? Understanding data ownership in clinical trials
In today’s increasingly digital and decentralised research landscape, one question is becoming more urgent: Who really owns clinical trial data? As clinical trials evolve, often involving multiple sponsors, CROs, investigators, […]
5 signs your clinical operations are ready for a CTMS
Managing clinical trials is no easy task. Between juggling timelines, tracking documents, coordinating teams, and meeting compliance requirements, it’s easy for things to fall through the cracks, especially if you’re […]
Simplifying administrative burden at research sites: How EDC can help
In clinical trials, quality data and regulatory compliance are non-negotiable. But for many research sites, the growing mountain of administrative tasks, from repetitive form-filling to data transcription and query resolution, […]
Making Risk-Based Quality Management work in clinical trials
In the world of clinical trials, quality isn’t just about ticking regulatory boxes, it’s about protecting patients, ensuring data integrity, and running efficient studies. As trials become more complex, with […]
