Press release -
E-revolution in clinical trials
In January 2018, Clinical Trial Consultants started their first remote clinical study based on electronic solutions. During the study, no physical visits to a clinic are conducted. Instead, both the screening visit with the physician and the subsequent check-ups by study nurses are conducted via video calls.
Katarina is one of the participants in the study and is now half way through the study.
“The video call application was easy to use and worked at my first attempt. I was taken just as seriously by the doctor as if I would have been there in person. I felt that I could go on talking as usual.”
In the study, there are no lab sample collections or any physical examination and the product is not classified as an investigational medicinal product (IMP), therefor this study is suitable for remote, digital conduct.
“I inform the patient about the study, ask questions about medical history and decide if the person can be included in the study or not. For this purpose, the technology works very well. Above all, it is very convenient for the patient who do not need to come here in person”, says Erik Rein-Hedin, Principal Investigator in the study.
Before a clinical study can begin, an informed consent must be signed. When the study visit is done digitally, the informed consent is signed by both parties using electronic bank ID.
"I feel safe knowing that no one else can pretend to be me," says Katarina.
"Now that we can use this kind of technology in clinical trials, I'm sure we'll see more of it in the future. It is exciting," says Erik Rein-Hedin.
Anders Millerhof, CEO, confirms that this e-solution is something CTC wants to keep using in future studies.
"Performing remote clinical studies using digital techniques increases the opportunity for more people to be involved. A clinic will have the possibility to include patients from all over Sweden and not just locally.”
Are you interested in learning more about e-solutions in clinical studies? November 15th at 15.30 to 18.30, representatives from CTC will give a lecture about this for the members of Apotekarsocieteten at Skåne University Hospital in Lund. Sign up here (the lecture is in Swedish).
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Topics
- Medical research
CTC Clinical Trial Consultants AB is a full-service CRO with focus on clinical conduct. Our mission is to facilitate clinical and translational research by providing our customers with cost-effective advice, conduct and reporting of clinical trials. We have four different departments: Clinic, Clinical Operations, Pharmacovigilance and Biometrics, all supported by independent quality assurance management.
Our head office and Phase 1 units are located in Uppsala comprising 28 beds of which 12 are hospital beds in a first-in-human approved research unit whereas our two professional sites for multicenter studies (SMOs) are found in Uppsala and Linköping. We have our own subject database for recruitment of both healthy volunteers and special patient populations.
CTC was founded in 2011 and has successfully conducted over 200 industry sponsored clinical trials for start-up companies as well as for international pharmaceutical companies and CROs. Our track record includes first-in-human, food effect, drug interaction, bioequivalence, bioavaliability and biosimilar studies, new drug delivery systems, medical device, PET/MR, QT and Phase IIa studies.
