The modern jargon “patient centricity” and patient-centric trials” have been revolving around the industry in recent times. However, there is a difference between patient centricity and patient engagement, which has been misinterpreted and interchanged often.
While patient engagement refers to the patient’s activity and retained participation in clinical trials, patient centricity refers to the design, development, and conduct of a clinical trial management solution, which is built around the core stakeholder – “The Patient”.
Five Key Essentials of Patient-Centric Clinical Trials
Incorporating the patient’s perspective in the clinical trial design is the essence to balance the scientific rigor and study feasibility for participants across the clinical trial phases. The main idea of patient centricity is to ensure smooth conduct and lessen the burden of the patient’s journey through the clinical trial process.
These best practices will ensure patient retention, smooth enhanced patient experience, high satisfaction rates, and improved data quality for clinical trials.
These underlined industry requisites are duly catered to by Cloudbyz CTMS. It offers seamless implementation of patient-centricity essentials throughout the clinical trial lifecycle.
Cloudbyz CTMS solution 100% natively built on Salesforce cloud-platform, is flexible and scalable to enable management and collaboration on clinical trial operations.
1. Detailed Patient Profiling and Early Recruitment
– Patient management via the patient portal:
- The patient portal provides the capability to forecast, monitor, and manage patient recruitment.
- Build awareness and educate the general public and target volunteer and patient population on clinical trials, process, benefits, and risks.
- View Publish eligibility criteria, Self Pre-screening services via website and Chatbot.
- Find nearest clinical Sites, Book screening appointments, provide driving directions on Google Map, book Transportation via Uber and Lyft and provide screening instructions and appointment alerts.
- Track and manage reporter including the person providing the case-related information. Track and manage patient information such as the patient’s past medical history and current conditions, and laboratory tests and test results.
2. Simplify Informed Consent & Standardization
– Cloudbyz eConsent:
- Template Driven: Cloudbyz eConsent solution is based on templates that enable a sequence of items and can be set up based on best practices.
- Interactive Multimedia Supported: Patients can navigate each section of the informed consent, ask questions, save it for later and continue when they are ready. eConsent Feature supports interactive multimedia approaches, supports the electronic signature, and converts eConsent responses to an electronic document.
- Real-time Monitoring: Real-time reporting and visibility on how patients read and understand consent documents.
3. Collaborate, Patients and Caregivers
The ClinicalWave digital platform enables collaboration between sponsors, investigators, and patients with unique capabilities covering:
- Patient recruitment (Patient Portal)
- Investigator Recruitment (Investigator Portal)
- Sponsor/CRO application to track interactions, budgets, real-time payments, recruitment campaigns, and referrals, etc.
ClinicalWave and Cloudbyz CTMS solutions also provide the ability for patients to use an app/patient portal to read and sign informed consent at the patient’s convenience.
4. Monitor Patient Safety
– Cloudbyz safety and pharmacovigilance Solution:
Cloudbyz Safety & Pharmacovigilance solution accelerator built 100% native on Salesforce Service Cloud offers the 360-degree view across R&D and commercial and helps enables pharma, biotech, and medical devices companies to make faster and better safety decisions, optimize global compliance, and easily integrate risk management.
5. Measure Outcomes and Performance Metrics
– Reports and dashboards:
- The reporting feature provides targeted, actionable, sustained, meaningful reporting that enables trial teams to take action on the issues detected with configurable, point-and-click reports and dashboards.
- Cloudbyz CTMS comes with pre-configured attributes based on industry best practices to track key performance metrics and historical performance for the sites including participation information and relative interest in participation.
- Site performance metrics feature provides capabilities to set up, track real-time performance and manage the site, evaluation, assessment, and selection initiation/ greenlight process.
The Cloudbyz CTMS solution is user-friendly with a simple and consistent design. It helps sponsors, CROs, and investigators in reducing the burden of documentation, collaboration, and measuring the outcomes of clinical trial testings with high-quality data.
The incorporation of Cloudbyz CTMS solution together with the ClinicalWave platform complements to bring patient centricity in clinical trials for sponsors, CROs, and Investigators.