“I think it is the ultimate goal to do as much as you can remotely because decentralized solutions present a win-win-win situation for patients, clinicians, and study sites,” said Henrik Blombergsson, COO and co-founder of Viedoc.
Digital technology is impacting clinical research extensively—and immutably. Post-pandemic, we have seen evidence of substantial benefits of decentralized clinical trials (DCTs) for all involved in clinical research, from the sponsor to clinicians and their patients. So, it’s no surprise that Viedoc has joined up with two other Scandinavian companies—LINK Medical and AlzeCure Pharma—to dive deeper into the potential of decentralized trials going forward.
During the enrollment phase, patients are screened to see if they meet the recruitment criteria with web-based questionnaires and interviews via our telemedicine solution, Viedoc Connect, which allows clinical staff to speak to and see the patient and connects to Viedoc Me, our engaging ePRO/eCOA designed for a better patient experience. Viedoc is validated and approved by regulatory authorities with 100% compliance.
Once a group of patients has been identified and approved, those patients must give their official consent to participate in the study in the form of eConsent. Viedoc offers a unique process to do so, including videos explaining the details of the study to share with patients and the informed consent form (ICF). Electronic signatures, or eSignatures, are also available in Viedoc, but the use and acceptance of these depend on a number of factors.
“This is why we also offer hybrid options, down to the level of individual study sites and patients,” said Henrik.
This ongoing trial does require on-site visits to monitor the effects of the treatment, but patients can fill out questionnaires at home to provide data to the site. Once a patient fills out a questionnaire, that data goes directly into the database so that site staff, clinicians, and data monitors can see what’s going on and when. This also allows for immediate intervention regarding errors, patient confusion, or even adverse events (AEs), and the clinical team can call the patient using Viedoc Connect if needed.
At the end of the clinical trial, participants will be interviewed about potential AEs at a follow-up visit—and depending on their preference, the visit can be conducted on-site or via Viedoc Me.
Decentralized solutions are an exciting new horizon that Viedoc was early to explore—and as a unified platform built in the cloud, so leading the evolution in this field comes naturally to us. Pilot studies, like this one, can help companies in the clinical research space learn about the benefits of new digital technologies and identify what technology may be developed to bridge the gaps between site and patient. From remote participation to the possibility of satellite study sites to replace on-site visits, we all look forward to the potential of a more digital future.
Are you interested in our eClinical suite? You can browse through our decentralized eClinical solutions or go ahead and contact us directly to learn how we can support your unique study requirements. Also, see LINK Medical’s website to learn about the benefits of their decentralized approach, and visit AlzeCure Pharma to find more detailed information on the ongoing pilot study.
"A user friendly data collection software with high function ability in the clinical trial space"