ePRO in long-term trials: designing for patient fatigue
When it comes to long-term clinical trials, patient engagement is everything. But as time goes on, even the most committed participants can lose motivation, especially if the burden of reporting […]
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 […]
Why small sites need a CTMs too
There is a common misconception about clinical trial management systems (CTMS) that they are only useful for large sponsors or multinational studies. The reality is that smaller research sites often […]
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 […]
