In Pursuit of Excellence: State of the Art Electronic Consent for Clinical Trials
FREMONT, Calif., August 22, 2024 (Newswire.com) - CliniOps, Inc., a premier technology, and data science company for the life science industry, has relaunched its state-of-the-art electronic informed consent (eConsent) module. With this advanced eConsent, stakeholders from pharmaceutical companies, Clinical Research Organizations (CROs), Investigators, and site staff can educate and enroll patients in clinical trials (CTs) based on latest regulatory requirements and guidelines issued by governing institutions. Patients considering participation in CTs will be assured that their rights and safety are fully protected as required by the International Council for Harmonization of Technical Requirements of Pharmaceuticals for Human Use (ICH) and Guideline for Good Clinical Practice (GCP).1,2
With the rise of decentralized clinical trials particularly during Covid-19 pandemic, regulatory agencies encouraged the use of remote or eConsent to protect the health and safety of the patients. CliniOps was among the few innovative technology companies who was fully prepared to deploy remote-based digital solutions to minimize disruption of ongoing CTs. CliniOps rolled out its eConsent to allow clinical sites to enroll patients from the convenience of their home or at the point-of-care.
“Informed consent is truly patient-centric. When we developed our eConsent module, we made sure that our technology is user-friendly with multi-lingual support. Investigators or the study team can use mobile devices to educate and obtain consent from patients, whether at home or clinical sites, streamlining the process of learning, understanding and participating in clinical trials,” said Avik Pal, CEO.
CliniOps eConsent supports both point-of-care and remote-consent. In both, patients can view an instructional video regarding the consent process, engage in dialogue with the investigator regarding study details, and sign the consent form once they understand the study requirements and are willing to participate. The investigator then reviews, countersigns, and emails a copy of the completed eConsent to the patient. The platform also provides support for Legally Authorized Representative (LAR) and for the pediatric participants (Ascent).
CliniOps eConsent provides significant benefit for patients - lessens trips to clinical sites; provides more time to understand the CT requirements from the comfort of their homes and with real time access to investigators for any questions or feedback; increased commitment to stay through the duration of the CT.
References:
- ICH
- Declaration of Helsinki; ICH GCP E6 (R2)7, ICH GCP E6 (R3)8, US 21 CFR9, US 45 CFR10, HIPPAA11, eIDAS12, GDPR13, EU Clinical Trial Directive14 and its replacement, the new EU Clinical Regulation15
About CliniOps:
CliniOps, Inc. is a premier Technology and Data Science company for the Life Science Industry, specializing in Hybrid and Decentralized Clinical Trials (Hybrid DCT). CliniOps Unified Platform facilitates home-visit, site-visit, tele-visit and lab-visit, integrating AI, Mobile, Analytics, Cloud, Sensors, and Connected Devices. With a global presence in 30+ countries, CliniOps accelerates trial conduct making drug trials accessible, inclusive, faster, and efficient. Visit https://cliniops.com for more details.
Source: CliniOps
