Sponsor and CRO’s Choice: Holistic On-Site, At-Home, and Virtual eSource Flexibility for Clinical Trials
Sometimes, it seems like your trial needs to tiptoe around what your technology can and can’t do. It doesn’t have to be that way.
Clinical Ink is the leading provider of eSource solutions that enables you to take the clinical trial approach that makes the most sense for your trial. All site-based visits, a combination of site- and home-based visits, or all home-based visits — whatever your study requires, Clinical Ink’s platform supports it with more flexibility than you will find anywhere else.
This blog discusses aspects of clinical trials our customers often ask about, and how our eSource ecosystem folds them into its overall operation for surprising optionality and holistic service that supports your entire clinical trial process, starting with eConsent.
At the start of any study, you can use the Clinical Ink eConsent solution for full eSource/direct data capture (DDC) or eCOA on-site data collection. Alternatively, our platform integrates with a variety of other third-party eConsent solutions. For full integration, this solution can simply be loaded onto the Clinical Ink device the site is already using for data collection.
eSource/Direct Data Capture
Clinical Ink provides a full eSource/DDC solution, along with fully integrated interactive randomization technologies (IRTs). Our technology can integrate with any number of IRTs but is most tightly integrated with Endpoint Clinical’s IRT solution, which enables sites to use push-button randomization from within the Clinical Ink solution.
Concierge Help Desk
Clinical Ink provides a single point of contact for sites to get technology help when using our eConsent (or third-party eConsent), eSource/DDC, eCOA, ePRO, and integrated IRT. Whether the question is about our own solutions or integrated solutions, you know exactly who to call or email to get support for technological challenges.
Patients can also contact the Clinical Ink help desk to get answers to questions about the use of our patient data collection tools.
Many studies combine at-home and on-site visits. To accommodate this design, Clinical Ink enables the use of doxy.me or other telehealth/visit tools on our provisioned tablets and smartphones. This solution allows clinical trial site personnel to organize and conduct secure, virtual patient visits. When reminded by our app, the patient logs into the site-specific doxy.me virtual waiting room. Clinical trial site personnel then admit the patient to the virtual examination room, where they meet privately and confidentially. Site personnel can enter data directly and cleanly into the Clinical Ink eSource/DDC (including eCOA) application. A picture-in-picture (PiP) setup ensures continuous face-to-face contact for the optimal patient experience during the virtual visit.
Home-Based Data Collection/ePRO and BYOD
Throughout the course of the study, Clinical Ink solutions provide reminders and track compliance for important, home-based tasks. These might include taking medications, completing a diary, answering a questionnaire, collecting an at-home measurement, and so on. These reminders are crucial for today’s complex studies to assist with patient recruitment and retention for the duration of your clinical trial. Clinical Ink, as the leader in bring your own device (BYOD), affords patients the comfort and convenience of using their own devices to complete diaries and questionnaires, track medication compliance, and receive ongoing reminders that ensure compliance with the protocol.
Depending on your study requirements, Clinical Ink can secure connected devices and wearables and synchronize them with provisioned phones for use in your study. These kits can be provided as bundled shipments for sites to distribute to patients for at-home data collection. Synchronization enables Clinical Ink’s provisioned phones to upload the device and wearables data to the appropriate data storage location.
Clinical Ink’s eSource tablets are ideal for deployment to virtual sites and/or for assignment to traveling coordinators or nurses. Each tablet is programmed to support the actual workflow the nurse needs to follow during home visits. Before visits, practitioners can download patient records to the tablet. During the home visit, results of their assessments can be captured directly in the tablet without the need for an internet connection. Relevant audio, video, or photography can also be saved during this home visit to form part of the patient record.
On returning to their home office/virtual site, the traveling coordinator or nurse can upload these data to Clinical Ink’s portal for immediate review and remote monitoring. Role-based permissions can be managed easily. Typical home health nurse data capture activities include: study drug administration (IV, injection, topical), blood draws (safety labs, PK, genomics), other biologic sampling, clinical assessments (vital signs, medical history, physical exam, concomitant medications, adverse events), patient training and education, study compliance checks, and patient questionnaires.
It Takes Experience to Deliver the Best Holistic, Hybrid Decentralized Trial Support
Clinical Ink has deployed this home health care/hybrid decentralized trial model in about 15 studies for rare diseases, pediatrics, and other indications. The largest was a 6,000-patient Ebola program in which traveling coordinators/nurses ventured out to collect data in Ebola “hot zones” in five northwest African countries. In some of our current COVID-19 projects, home-based coordinators carry their tablets to remote or nontraditional clinical research sites.
This list shows the diversity of study indications we have supported:
- Treatment-resistant depression
- Multiple sclerosis
- Hemophilia (including pediatric)
- Speech, language, and cognitive intervention in stroke patients
- Childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE)
- Depressive symptoms with multiple sclerosis (DSMS)
- Fragile X syndrome
- Precocious puberty
- Sickle cell anemia
Don’t let your technology dictate your clinical trial approach. Whether it’s site-based visits, home-based visits, or both, Clinical Ink has the experience, broad solutions, and extreme flexibility to support your research needs.
Need more details? Read about how Clinical Ink’s advanced logistics and data capture supports rapid, cost-effective infectious disease research in this blog.