Go to ScienceSoft Global
Clinical Trial Portal for Patient Engagement
Features, Development Steps, Costs
In healthcare IT since 2005, ScienceSoft engineers patient portals for life science research organizations, hospitals, outpatient clinics, and laboratories, prioritizing patient experience and trial management automation.
Clinical Research Portal for Patient Engagement: Essentials
Clinical trial portals let patients view trial-related information, submit applications, perform trial activities remotely, access personal health information, and receive training and support. For research organizations, such portals optimize researchers' workload and enhance patient engagement and retention.
Patient portals are an essential tool for decentralized and hybrid clinical trials, which are expected to account for 80-90% of studies by 2027.
Custom clinical trial portals for patient engagement are a way for research organizations to implement tailored features that match their operational needs. Additionally, custom research portals can be engineered for direct integration with all required systems, including legacy and third-party software.
- Implementation time: 4 to 10+ months.
- Typical integrations for a research participant portal: eConsent and electronic clinical outcomes assessment (eCOA) software, an electronic data capture (EDC) system, a telemedicine solution, patient management and clinical trial management systems, and participant payment software.
- Costs: $100,000–$300,000+, depending on complexity. Answer a few questions, and our consultants will get back to you with a free quote for your project.
Core Capabilities of a Clinical Trial Portal for Patient Engagement
Patient-facing features
Discovering a trial and enrollment
- Plain language trial summaries with information on the study purpose, risks, benefits, and participant responsibilities.
- Prescreening questionnaires to match patients with the correct study and check their eligibility.
- Locating the nearest site and submitting the participation request.
- Viewing the schedule of prescreening and screening examinations and accessing their results.
- Signing a consent form electronically, either independently or during a video call with a site staff member.
Clinical trial participation
- Filling out eCOA forms (self-report diaries on symptoms, medication intake, adverse events, etc.) remotely.
- Built-in controls for missing or invalid data input with tooltips on how to fix the problem.
- Remotely study visits via video calls.
- A built-in calendar for checking scheduled appointments and requesting time adjustments.
- Tracking the home delivery of study medications.
- A dashboard showing the amount of paid compensations and a timeline for future payments.
- Viewing the collected data from connected wearable or sensor devices.
Engagement features
- Notifications, reminders, and prompts for planned trial activities (e.g., upcoming appointments, scheduled study tasks).
- Automated rescheduling suggestions for missed visits.
- Personalized offers for patients with low compliance (additional training, nurse visits, remote consultations, etc.).
- Personalized motivational messages.
- Gamification features, e.g., badges, rewards, and other incentives for adherence.
Trial knowledge and support
- Self-training on research activities (via articles, interactive courses, video tutorials, questionnaires, quizzes).
- Viewing trial progress, planned trial activities, and other trial-related information.
- Viewing the prescribed medication regimen and recommendations on diet, physical activity, skin lesion care, etc.
- Accessing materials on symptoms, tests, disease management, medications, and lifestyle (FAQs, articles, checklists, guides, etc.).
- Instant messaging with the investigator or nursing staff.
- Scheduling and receiving remote consultations with investigators and research nurses via video calls.
- Requesting reimbursements for travel expenses related to on-site visits, side effect treatment, etc.
Post-trial activities
- Viewing trial results after its completion.
- Reporting long-term treatment outcomes.
- Reporting adverse events.
Accessibility
- Features for patients with disabilities and conditions that complicate their interaction with the portal (an adaptive keyboard and voice input for patients with motor disorders, etc.).
- Compliance with ADA Standards for Accessible Design, the Web Accessibility Directive, WCAG, and other related guidelines.
Research staff and admin-facing features
Patient account management
- Creating patient profiles or generating invite links to grant patients in relevant registries access to the portal.
- Administering patient profiles, setting access levels and credentials, and editing patient information manually and in bulk.
- Revoking access to the portal and terminating accounts for single patients and user groups.
- Granting former participants access to the portal to share research findings and collect data on long-term treatment effects.
Portal content management
- Creating and managing trial knowledge base content, including texts, multimedia, questionnaires, interactive training materials, etc.
- Publishing, versioning, and storing IRB-approved trial informed consent forms and patient-facing trial descriptions.
- Setting up patient-facing dashboards, activity schedules, data-collecting forms, etc.
Analytics
- Customizable reports on screening progress, patient statuses, diary completion rates, treatment compliance, etc.
- A dashboard with patient engagement metrics (e.g., time spent on viewing training materials and adherence to activity schedule).
Patient communication and support
- Integrated messaging, voice and video calls.
- Setting up automated notifications and messages to remind about trial activities and promote compliance and retention.
- Inquiring extra information (via messaging) and assigning extra activities (e.g., training, visits, consultations, study drug deliveries).
- Addressing patient questions and support requests (for reimbursement, schedule adjustment, assistance with questionnaires or portal use, etc.).
Compliance, security, and data privacy
- User access controls (role-based action permissions for patients, caregivers, investigators, research nurses, admins, etc.).
- Encryption of all patient data at rest and in transit.
- Multi-factor authentication (MFA).
- Full audit trail of user and system activities, including time stamps.
- Compliance with FDA 21 CFR Part 11, GCP guidelines, HIPAA, HITECH, GDPR, and other applicable regulations.
Need a Portal for Your Clinical Trial Participants?
ScienceSoft's healthcare IT consultants are here to ensure that your clinical trial portal is compliant with regulations and convenient for site staff and patients. They're also ready to answer any questions regarding the potential costs, timelines, technologies, and other aspects of portal development.
Essential Systems to Integrate with a Clinical Trial Participant Portal
- Telemedicine platform — to let patients attend remote visits directly via the portal; to organize remote consultations, e.g., during the signing of the eConsent form.
- Electronic clinical outcome assessment (eCOA) software — to enable patients to fill out self-monitoring diaries and medication logs on the portal.
- Electronic data capture (EDC) system — to let patients view their test results and medical advice.
- Patient management system — to capture and log messages exchanged on the portal between patients and research staff.
- Clinical trial management (CTMS) system — to let patients view and adjust their visit schedule and track the study drug delivery to their homes.
- Participant payment solution — to provide patients with information on the paid compensations and planned future payments.
Steps to Develop a Clinical Trial Portal for Patient Engagement
Below, we provide a general overview of the development process for a clinical trial participant portal. As part of custom development, ScienceSoft's experts create an individual roadmap for each research organization, specifying milestones, timeframes, budgets, and risk management strategies.
1.
Business analysis, requirements engineering, and architectural design
Business analysts work with stakeholders (the trial organization's management, investigators, and hospital staff) to understand their requirements for the future solution. Additionally, the team studies the participants' potential needs and pain points (e.g., low technology literacy or vision impairments that make using the portal difficult).
Software architects examine existing systems that need to be connected to the portal. They determine the appropriate architectural design and choose optimal integration methods to address potential challenges, e.g., to achieve interoperability between the portal and a legacy EDC system.
ScienceSoft
2.
Compliance planning
Typically, a clinical trial portal for patient engagement needs to support compliance with Good Clinical Practice (GCP) guidelines, FDA 21 CFR Part 11, HIPAA, HITECH, GDPR, and other relevant country-specific regulations. Compliance consultants specify the features required for the software to meet applicable regulatory standards, such as multi-factor authentication (MFA), patient data encryption, audit logs, etc.
ScienceSoft
3.
UX/UI design
UX designers model the optimal user journeys, while UI designers create convenient interfaces tailored to target user groups. For example, the interface for elderly patients must feature large, easily visible elements, accommodating poor vision and difficulties with fine motor skills. It's also essential to add tooltips about key actions and the purpose of portal elements, making them clear for people with limited tech proficiency.
ScienceSoft
4.
Iterative development and QA
For patient portal development, an iterative approach is typically employed, with features released in stages. It enables gathering early feedback from patients and planning portal improvements for the next iterations. For example, if patients note that it's hard to find time to fill out long diaries, the team, together with researchers, could explore ways to simplify this process. For instance, they may consider adding an option to save partially filled diaries that let patients take breaks without the fear that the unfinished diary entry will get lost.
Testing is usually performed during every iteration and before every release, including unit, functional, performance, usability, integration, and security tests, to ensure the software meets the specification requirements and operates smoothly.
ScienceSoft
5.
Deployment and Support
Upon the portal's launch, it's necessary to ensure user support, enabling both patients and portal administrators to request assistance or report remaining bugs. For research portals with many users and advanced functionality, such as video conferencing, a dedicated support team may be necessary to resolve performance challenges and respond to user requests promptly.
ScienceSoft
How Much Does It Cost to Develop a Custom Clinical Trial Portal for Patient Engagement?
Drawing from ScienceSoft's experience in creating custom patient portals, the costs for a clinical trial portal for patient engagement range from $100,000 to $300,000+. The key cost factors are the number of integrated systems, the need to collect data from wearables and sensors for patient monitoring, and the demand for telemedicine functionality.
Need a more precise figure?
Why Choose ScienceSoft for Your Clinical Trial Portal Project
- Since 2005 in healthcare IT.
- 150+ successful projects in the domain.
- Experience in meeting GCP, FDA, HIPAA, HITECH, and GDPR requirements.
- ISO 13485- and ISO 9001-certified quality management system, ISO 27001-certified information security management system.
Our Awards and Recognitions
Listed among Healthcare IT Service Leaders in 2022 and 2024
Growing faster than Amazon, Google, and ServiceNow
Recognized for reliability and trustworthiness
Recognized by Health Tech Newspaper awards for the third time
Top Healthcare IT Developer and Advisor by Black Book™ survey 2023
Best in class in medical device connectivity (2023)
A top outsourcing provider for three consecutive years
ISO 13485-certified quality management system
ISO 27001-certified security management system
ScienceSoft as a Trusted Partner for Custom Web Portal Development
Todd Nilson
MD
ScienceSoft proved to be a reliable vendor with a solid healthcare background, and we recommend them to everyone looking for a telehealth software development partner.
We teamed up with ScienceSoft trusting a solid experience that the company had in the domain of web portal development, and never regretted the decision.
Vilnis Vitolins
Owner
We hired ScienceSoft to help our team with frontend portal development. ... ScienceSoft’s team is highly skilled and extremely committed to providing excellent results.
What makes ScienceSoft different
Driving success in healthcare IT projects no matter what
ScienceSoft develops healthcare IT solutions that reduce care delivery costs and improve outcomes, no matter the challenges posed by diverse expectations of medical staff, shifting priorities, and resistance to change.
