Digitization of health care is very often discussed at scientific conferences and during expert debates. Significant technological progress gave physicians an opportunity to more frequently use mobile and wearable devices in diagnostics. During the COVID-19 pandemic, the FDA issued a special authorisation for the use of such equipment in clinical trials. It is sensible to assume that these devices will be an increasingly popular solution used for recording study endpoints.
The term ‘digital endpoints’ means clinical study endpoints determined thanks to the use of sensors such as smart phone microphones, wearables and digital pills to guarantee more frequent, objective, remote monitoring of patients during clinical trials.
Devices equipped with special sensors allow a large amount of accurate data to be collected. They can collect and transmit information about the activity of patients and their daily recorded vital signs directly to investigators. Access to state-of-the-art technologies can significantly influence the study design, helps improve processes, and is relevant when it comes to recruitment, retention of patients and other aspects of a study.
Apart from facilitating certain processes, digital patient monitoring poses further challenges for researchers, such as cybersecurity or equal involvement of volunteers from all age groups, who are not always equally comfortable when operating digital devices and applications. However, as usual, a key to the success and popularization of such research methods is clear and accurate communication with target groups, which includes policy makers, representatives of state authorities, manufacturers and distributors of equipment in individual regions, and ultimately the key actors in the whole process, namely patients.
We help to properly formulate messages and information to be used at each stage of clinical studies, for example:
- announcements of recruitment for a clinical study
- patient information sheets and informed consent forms
- patient’s diaries
- clinical study participant’s cards
We translate the following materials from and into all European and Asian languages:
- clinical trial protocol synopsis
- labels for investigational medicinal products
- clinical trial agreements
- adverse event documentation
- SUSAR reports/PSURs
- correspondence with relevant authorities and ethics committees
- clinical trial authorizations
- powers of attorney granted by the sponsor to CRO
- documents authorising the legal representative of the sponsor to act in the territory of the Member States on behalf of the sponsor
We use technology and experience to speed up multilingual communication in life sciences.