CLINICAL TRIAL READINESS ASSESSMENT
Are you really ready to run a clinical trial? How can you best assess your clinical trial readiness? We work with C-level executives and management boards and understand their objectives, constraints and timelines. Do this before buying services for clinical data management, EDC, ePRO and biostatistics. Using a fixed price, fixed delivery model, our clinical trial readiness […]
Home alone and in a clinical trial
1 in 7 American adults live alone COVID and social isolation is part of our lives. During COVID, it became easier to recruit patients for clinical trials. Like increased online shopping during social isolation of COVID? How do deal with patients who are home alone and in a clinical trial? But — somehow, that seems […]
Preventing drug counterfeiting
Counterfeiting is old as money itself. Drug counterfeiting is no exception. In this post, we’ll share an analytical approach that you can use to estimate the risk of drug counterfeiting to your drug products. Why are Medicines a Target for counterfeiting? Pharma is a highly regulated sector. Why do drugs attract counterfeiters? Fakes can be […]
What risks really count for your clinical trials?
Is there a “black-box” risk management solution for your clinical trial? What clinical trial risks are the most important for you and your company? Risk mitigation and risk management for your clinical trials What clinical trial risks really count for your company? No question is more important for implementing an effective program of risk-mitigation and […]
Dealing with information junkies in decentralized clinical trials
DecentraIized clinical trials software vendor Medable is doing an outstanding job in understanding and executing an online work-flow between sites and patients at home.. This understanding and execution is a necessary but insufficient condition for the success of decentraIized clinical trials. At their core, decentraIized clinical trials and hybrid studies have the same issues as any clinical research project. These […]
Preventing patient data leaks
6 ways to protect patient data in your eClinical and digital health applications Patient data leaks is much more than patient privacy. Patient data leaks require a more complete approach to threat mitigation of patient data leakage, availability and data integrity attacks. Since 2019, we see rapidly increased use of decentralized clinical trials, hybrid trials, […]
Knowledge Prostitution in clinical data
Friday, a client asked me about privacy, data security and social networking in clinical trials. The client told me that they were considering using a physicians‘ portal to market their digital therapeutic product after they completed their pivotal clinical trial. (See my article on 4 strategies to get FDA approval for your medical device ). […]
