Klinisol Product information

Last Updated: June 12th 2021

Participant recruitment and retention are two major uphill battles in conducting clinical trials and contribute extensively to clinical trial delays. They are essential for both scientific validity of the clinical study and economic reasons. The potential challenges, such as social distancing and quarantines, result in study participants’ inaccessibility and trial personnel for inperson scheduled study visits and/or follow-up.

Klinisol eConsent application is a patient centric solution that supports clinical research entities increase patient recruitment and retention by reducing the cost, time, and effort through employment of regulatory compliant virtual communication.

COVID-19 accelerated the industry’s move to digital solutions that enable decentralized trials and keep studies on track, speed study start-up, and improve trial execution. Klinisol eConsent enables this transformation through digital informed consent document creation, approval, and exchange, therefore reducing the time spent on administrative tasks, increasing site and patient engagement throughout a study. Klinisol eConsent empowers patients and sites with the digital informed consenting solution as well as improves patient education and retention. The informed consenting process performed with the Klinisol eConsent application, ensures verifying identification of the patient or the LARs, comprehension, and obtains appropriate documentation.

Klinisol eConsent is a HIPAA and 21 CFR Part 11 FDA compliant application. The subject and the clinical research professional can manage the informed consenting process from their 844-243-1231 info@klinisol.com KLINISOL own portable device, be it phone or tablet, through activation of video or voice calls with complete security features that ensure regulatory compliance. Compatibility includes iOS and Android platforms that allow for real time eSignature/consenting and clinical trial data management. Up to date security standards for data encryption at all times ensure the preservation of the confidentiality of patients’ Personal Health Information. Through state-of-the-art technology, patients or LARs can communicate with clinical research personnel and perform real time data entry, essential for ongoing clinical trials, enrolled patients, and potential trial patients.

Virtual communication and pre-trial screening ensure cost and time effective completion of enrollment goals for sites, it reduces screening, enrollment time and effort as well as ensures compliance with real-time communication. Clinical research personnel, principal investigators, sub-investigators, research coordinators can enter, sign and upload digitally signed documents from their own phone on the spot, while interacting with the patient or at a later stage if so chosen, therefore reducing the time and effort spent for the clinical trial documentation process. Klinisol eConsent is a modular based versatile app that can be fully integrated with any existing EDC thus taking care of the consenting process as a whole and not alone. Screening, baseline or follow up elements of the clinical research protocol such as initial consent discussion with the patient or the Legally Appointed Representative, patient eligibility as well as inclusion exclusion criteria forms, can be documented, digitally signed by the research staff with assigned privileges, serve as legal documents and placed in the patient binder, be it electronic or hard copy. The video or voice recording of the informed consenting process, that takes care of documenting the patient understanding, is encrypted, and stored on a HIPAA compliant server. This centralized informed consenting process offered by Klinisol eConsent application, enhances the ease of retrieval of source data for inspections, audits, and monitoring, compliant with ICH GCP and acceptable to regulatory agencies and Institutional Review Boards (IRBs)/Ethics
Committees (ECs).

For more information in relation to the functioning of the Klinisol eConsent application, you can visit our web-page, www.klinisol.com, or the Klinisol YouTube channel containing the training videos for patients and clinical research personnel.
Thank you for being our valued partner,