Presenting eConsent in Clinical Trials
Traditional paper-based consent forms were long and difficult to read, requiring over a ninth-grade reading level and gradually becoming obsolete. In fact, 35% of people left clinical trials because they didn't understand the forms.
eConsent (Electronic Consent) has transformed the clinical trials landscape by moving from paper to digital methods. This new format uses multimedia to make understanding easier for everyone. It's especially helpful for people with different reading skills.
Additionally, about 30% of people drop out of trials, which costs a lot. eConsent makes it easier and can help keep more people in the trial. For example, doing consent online saves patients the trip to the doctor's office.
Only a small number of people, about 4%, join clinical trials now. Making things easier from the start could help more people join. eConsent makes it simpler to start.
eConsent also helps with following the rules. Many FDA warnings lately were about consent issues. Good eConsent processes can avoid these problems. A survey found 59% of doctors think eConsent will be more common, and 40% see it as a top tool in research.
In conclusion, eConsent optimizes patient experience, makes trials run smoother, and follows the rules better.
Main Takeaways
- eConsent platforms revolutionize how we obtain informed consent in clinical trials
- Digital consent provides easier enrollment and helps participants understand better
- These tools break down distance barriers and make joining trials simpler
- Only 4% of people currently participate in clinical trials — eConsent can increase this rate
- 59% of physicians believe eConsent will become more common in the coming years
- eConsent ensures privacy and follows regulations with custom forms and clear data handling
Advantages of Using eConsent Platforms
eConsent platforms bring many benefits to clinical research. They make the patient consent process smoother and more effective for everyone.
Improved Participant Comprehension
eConsent platforms help patients understand the trial better. They use interactive and multimedia content to educate patients. This makes sure patients know what they're getting into.
Maximized Accessibility
eConsent platforms make it easier for people to join studies. You can sign up and consent from anywhere, breaking down old barriers. Before COVID-19, 59% of people knew about e-Consent, and 27% started using it later.
Regulatory Compliance
eConsent platforms help keep clinical trials in line with the law. They keep documents up-to-date and follow rules like HIPAA. This protects patient privacy and data.
Main Features to Look for in eConsent Software
When choosing an eConsent vendor, focus on key features that boost the trial process. The right tool makes consent easier and keeps things secure and compliant.
Customizable Consent Templates
Being able to change consent templates is vital in the best eConsent tool. It lets you tailor forms for different studies and patients. This means you can use templates in many languages, helping patients understand no matter their language.
Secure Digital Signatures
It's very important to make sure consent is genuine. Secure digital signatures keep the consent process safe. They make sure signatures are legal and can be checked. Plus, they protect against hackers and data theft.
Real-time Tracking and Audits
Keeping track of consent in real-time is crucial. It makes sure everything is clear and follows the rules. With the best eConsent tool, you can spot problems fast and keep on track with laws.
Seamless Integration
eConsent platforms must integrate seamlessly with other clinical trial systems (EDC, ePRO, etc.). This improves data flow, optimizes trial management, and creates a unified technology setup.
MILO Healthcare: Leader in eConsent for Decentralized Trials
MILO Healthcare is recognized for its work on decentralized trials and ePRO solutions. The MILO platform uses advanced clinical trial technology to make the patient consent process smoother and improve the participant experience through remote consent.
MILO's solutions include patient recruitment, engagement, televisits, ePRO, and more. These services make it easier and faster for patients to participate from anywhere. This is key for the success of modern clinical trials.
Why Choose MILO Healthcare?
The MILO platform is essential for decentralized trials. It allows patients to participate from home, making studies more inclusive. This way, they overcome location issues and ensure everyone follows the same rules, making data more reliable.
With multimedia tools, MILO helps participants fully understand the trial, making the patient consent process better and more transparent.
Discover MILO Healthcare →Top 10 eConsent Platforms for Clinical Trials
Looking at the always evolving realm of healthcare, creating eConsent platforms has become paramount for better clinical trials. We take into account the user experience, security, and more to find the best ones. Our eConsent software rankings show the top picks leading the way in clinical trials.
A 2015 survey showed most people prefer ePRO over paper for tracking health. A 2013 study found 77.3% of patients like electronic forms better than paper. This shows why eConsent platforms are getting better and more popular.
1. MILO Healthcare
MILO Healthcare leads in creating eConsent solutions for trials without a central location. They use advanced clinical trial technology to make the patient consent process smoother. This also improves the experience for participants through remote consent. Their work is changing how we do clinical research today.
Decentralized Trials
MILO's platform is key to their decentralized trials. It lets patients join trials from home, making studies more inclusive. This way, they overcome location issues and ensure everyone follows the same rules, making data more reliable.
Optimized Participant Education
MILO platform has tools like eConsent, ePRO, telemedicine, scheduling, and device integration. This helps manage studies better and help participants understand what's needed. With multimedia, MILO helps participants fully understand the trial, making the patient consent process better.
Key Features
- All-in-one EDC platform for medical device trials
- Modules: eCRF, ePRO, eConsent, Survey, Cohorts, Randomization
- Compliance: 21 CFR Part 11, ICH-GCP, GDPR, HIPAA, HL7 FHIR, OMOP CDM, DICOM
- Real-time dashboard and point-and-click design
- AI-driven patient recruitment
- Automatic transcription (MILO Voice)
- PDF/EMR capture (MILO Video)
- Support for 43+ MedTech companies in 20+ languages
2. Medidata
Medidata is a top choice for clinical trials, earning a Leader spot in Everest Group's "Decentralized Clinical Trials Platforms PEAK Matrix® Assessment 2023." It's the only one to get a "Star Performer" label for two years in a row. This makes Medidata a top pick for those in clinical research and sponsoring trials.
Comprehensive Platform Solutions
Medidata's platform offers a wide range of solutions for clinical trials. It supports eConsent solutions and electronic signature platforms. This ensures informed decisions and makes trial processes smoother. The platform has powered nearly 1,700 Decentralized Clinical Trials (DCTs) and reached over 1.1 million patients across various diseases and trial phases.
Advanced Analytics & AI
Medidata also boosts trial efficiency with its analytics and the biggest patient-level historical clinical trial dataset globally. They invest in next-generation, patient-focused technologies like Medidata AI, Medidata```html Patient Cloud, and the Medidata Diversity Program.
Key Features
- Leader in Decentralized Clinical Trials Platforms
- Powered nearly 1,700 DCTs reaching 1.1M+ patients
- Electronic signature platforms integrated in eConsent
- Randomizes patients and sends treatment kits directly from EDC
- Advanced analytics with largest patient-level historical dataset
- Medidata AI, Patient Cloud, and Diversity Program
- Seamless integration with clinical trial systems
3. Veeva
Veeva stands out in the world of electronic informed consent. It offers a top-notch digital consent solution. This platform makes sure it follows strict rules and works well with other clinical systems. It gives a smooth experience for those involved in clinical trials.
Regulatory Compliance
Veeva is known for its focus on following the rules, which makes the consent process easier. It changes the old paper consent to a digital one. This makes setting up, filling out, and checking consent forms faster and more efficient. It also makes sure everything meets strict rules.
Seamless Integration
Veeva's platform works well with other digital tools, creating a single system for managing clinical data. For example, Veeva's Vault Connections make moving data between vaults easy, making data management more efficient. Veeva's Site Connect also automates sharing information, switching from old paper methods to digital ones.
Proven Efficiency
Statistics show how well Veeva works. Its Vault EDC cuts down the time it takes to manage clinical data by more than half. The Veeva CDB can reduce data cleaning by up to 50%. And, early adopters have seen a 50% drop in setting up EDC databases.
Key Features
- Top-notch digital consent solution
- Strict regulatory compliance focus
- Vault Connections for seamless data movement
- Site Connect automates information sharing
- Vault EDC reduces clinical data management time by 50%+
- Veeva CDB reduces data cleaning by up to 50%
- 50% reduction in EDC database setup time
4. Signant Health
Signant Health is making big waves in the eConsent software and clinical trial technology world. Their Signant SmartSignals eConsent is changing the game for small and mid-size trial sponsors. It offers flexibility and a wide range of features for today's clinical research.
Two-Tier Solution Approach
They offer two main options: Essential and Enterprise. These options meet different customer needs:
- Essential: Core eConsent functionality for smaller trials
- Enterprise: Advanced features including audit-ready systems and flexible re-consenting
Industry Leadership
Signant Health is a leader in GxP inventory management. Over the past 20 years, they've worked with over 400 sponsors and CROs, including all Top 20 pharmaceutical companies. Their focus on patient safety shines through their technology, which makes clinical trial supplies easier to manage.
Patient-Centric Benefits
Research shows how eConsent software really helps patients. Studies show it makes patients understand better and feel happier. For example, older adults find it more engaging thanks to its interactive features.
Key Features
- SmartSignals eConsent for small and mid-size sponsors
- Essential and Enterprise tier options
- Audit-ready systems
- Flexible re-consenting capabilities
- 20+ years of GxP inventory management experience
- Worked with 400+ sponsors and CROs
- Interactive features improve patient engagement
5. Florence Healthcare
Florence Healthcare uses a cloud-based platform for remote and team-based consent. It supports electronic signatures, making paperwork easier. This ensures the consent process is legal and easy to check, making it a strong choice for clinical trials.
Cloud-Based Flexibility
The cloud-based architecture allows for remote consent collection, enabling participants to review and sign consent forms from anywhere. This is particularly valuable for decentralized and hybrid trial models.
Team Collaboration
Florence Healthcare supports team-based consent workflows, allowing multiple stakeholders (investigators, coordinators, participants) to collaborate seamlessly throughout the consent process.
Key Features
- Cloud-based platform for remote consent
- Electronic signatures for paperless workflows
- Team-based consent collaboration
- Legal compliance and audit trails
- Supports decentralized and hybrid trial models
- Easy verification and tracking
6. Sano Genetics
Sano Genetics is notable for its user-friendly interface, making consent simple for everyone. It uses top-notch encryption to keep data safe. This follows global data laws and keeps participants trusting the process.
User-Centric Design
The platform prioritizes ease of use, with intuitive interfaces that make the consent process accessible to participants of all technical skill levels and literacy backgrounds.
Data Security & Privacy
Sano Genetics employs advanced encryption methods to protect participant data, ensuring compliance with global data protection regulations including GDPR, HIPAA, and other regional privacy laws.
Key Features
- User-friendly interface for all skill levels
- Top-notch encryption for data security
- Global data law compliance (GDPR, HIPAA)
- Builds participant trust through transparency
- Accessible design for diverse literacy levels
- Secure data handling throughout consent lifecycle
7. Science 37
Science 37 has innovative eConsent for decentralized trials. It supports remote consent through telehealth and uses multimedia to educate participants. This makes trials more inclusive and focused on what participants need.
Decentralized Trial Expertise
Science 37 specializes in decentralized clinical trials, with eConsent as a core component of their end-to-end DCT platform. Their approach brings trials directly to participants, eliminating the need for site visits.
Telehealth Integration
The platform seamlessly integrates eConsent with telehealth capabilities, allowing participants to review consent materials, ask questions via video consultation, and sign electronically—all from home.
Multimedia Education
Science 37 uses videos, animations, and interactive content to help participants understand complex trial information, improving comprehension and informed decision-making.
Key Features
- Innovative eConsent for decentralized trials
- Remote consent through telehealth integration
- Multimedia participant education (videos, animations)
- End-to-end DCT platform
- Eliminates need for site visits
- Participant-centric approach
- Improved comprehension through interactive content
8. ArisGlobal
ArisGlobal offers cloud software for clinical research data collection, using over 30 years of experience. Their eConsent solutions are built on a foundation of regulatory expertise and life sciences technology.
Decades of Experience
With over 30 years in the life sciences technology space, ArisGlobal brings deep regulatory knowledge and clinical trial expertise to their eConsent platform.
Cloud-Based Architecture
The cloud-based platform ensures scalability, accessibility, and real-time data synchronization across global trial sites, making it ideal for multi-site and international studies.
Comprehensive Data Collection
ArisGlobal's eConsent integrates seamlessly with their broader clinical data collection suite, providing a unified platform for managing all aspects of clinical trial data.
Key Features
- 30+ years of life sciences technology experience
- Cloud software for clinical research data collection
- Deep regulatory expertise
- Scalable cloud-based architecture
- Real-time data synchronization
- Integration with comprehensive clinical data suite
- Ideal for multi-site and international trials
9. Castor EDC
Castor EDC is a top choice with over 65,000 users worldwide. It lets sponsors quickly build studies with templates, making it one of the most accessible and user-friendly eConsent platforms available.
Global User Base
With over 65,000 users across the globe, Castor EDC has proven its reliability and effectiveness in diverse clinical research settings, from academic institutions to pharmaceutical companies.
Template-Based Study Building
Castor EDC offers pre-built templates that allow sponsors to quickly set up studies, including eConsent workflows, significantly reducing study startup time.
User-Friendly Interface
The platform is known for its intuitive design, making it accessible to researchers without extensive technical training, while still offering powerful features for complex trials.
Key Features
- 65,000+ users worldwide
- Quick study building with pre-built templates
- User-friendly, intuitive interface
- Suitable for academic and pharmaceutical research
- Significantly reduces study startup time
- Powerful features for complex trials
- Proven reliability across diverse settings
10. AssisTek
AssisTek stands out, working with over 75 companies in various studies. Their eConsent platform is designed to support a wide range of therapeutic areas and study types, from early-phase to post-market surveillance.
Extensive Partnership Network
AssisTek has built strong relationships with over 75 companies, demonstrating their ability to adapt to different organizational needs and study requirements.
Versatile Study Support
The platform supports various study types across multiple therapeutic areas, making it a flexible choice for organizations conducting diverse clinical research portfolios.
Proven Track Record
With experience across numerous studies and therapeutic areas, AssisTek has developed a robust eConsent solution that addresses real-world challenges in clinical trial consent management.
Key Features
- Partnership with 75+ companies
- Support for various study types
- Multiple therapeutic area expertise
- Flexible platform for diverse research portfolios
- Early-phase to post-market surveillance support
- Robust consent management capabilities
- Real-world proven solution
Market Outlook
The eConsent software market is expected to reach USD 996.6 million by 2031.This growth shows more people are using these platforms. Cloud solutions and general consent are expected to grow fast, especially in North America and Europe.
These top platforms are efficient and reliable, shown by their high compliance rates and fast adoption. The Top 10 eConsent Platform list is key for those looking to improve their clinical trials.
Frequently Asked Questions (FAQ)
What is an eConsent platform?
An eConsent platform is a digital system for clinical trials. It lets people review and agree to consent forms online. It uses interactive tools to make it easier to understand and access.
How does eConsent improve the patient consent process?
eConsent makes getting consent easier by offering clear multimedia content. Patients can access consent forms online and sign them securely. This makes it easy for them to make informed choices from anywhere.
What are the key features to look for in eConsent software?
Look for customizable consent templates, secure digital signatures, and real-time tracking. These features make the process fit your trial needs, keep data safe, and follow the rules.
How do eConsent platforms enhance participant comprehension?
eConsent uses interactive and multimedia content like videos and quizzes. This makes complex medical info easy to understand and engaging. It helps participants fully grasp the trial's details and what it means for them.
Why is regulatory compliance important in eConsent platforms?
Following the rules is key to ensure the consent process is legal and safe. eConsent platforms that follow laws like HIPAA protect patient data and keep the consent process honest. This builds trust and follows the law.
Can eConsent platforms be integrated with other clinical trial technologies?
Yes, eConsent platforms work well with other clinical trial systems. This makes data flow better, improves trial management, and creates a unified technology setup. It makes trials more efficient overall.
What advantages do eConsent platforms offer for decentralized trials?
eConsent is great for decentralized trials because it lets people consent remotely. It supports telehealth and offers easy-to-use digital info. This makes trials more open and focuses on what participants need.
How do secure digital signatures work in eConsent software?
Secure digital signatures in eConsent software let people sign consent forms online. These signatures are safe and legally the same as handwritten ones. They make the consent process secure and valid.
What makes MILO Healthcare a notable eConsent platform?
MILO Healthcare is recognized for its work on decentralized trials and ePRO solutions. The platform uses advanced clinical trial technology to make the patient consent process smoother and improve participant experience through remote consent. It offers comprehensive features including eConsent, ePRO, telemedicine, AI-driven recruitment, and supports 20+ languages.
How does Medidata's eConsent solution enhance trial participation?
Medidata's eConsent focuses on helping people make informed choices. It has a user-friendly design and tracks things in real-time. This boosts trial management and keeps participants engaged while keeping data safe and following the rules. It has powered nearly 1,700 Decentralized Clinical Trials (DCTs) and reached over 1.1 million patients.
What are the benefits of Florence Healthcare's eConsent services?
Florence Healthcare uses a cloud-based platform for remote and team-based consent. It supports electronic signatures, making paperwork easier. This ensures the consent process is legal and easy to check, making it a strong choice for clinical trials.
What distinguishes Veeva's eConsent platform?
Veeva's eConsent is top-notch at following rules and working with other clinical systems. It makes getting consent smooth for participants and trial managers. This leads to better trial management and a good experience for everyone. Veeva's Vault EDC cuts down clinical data management time by more than half.
Why choose Signant Health's SmartSignals eConsent?
Signant Health's SmartSignals eConsent meets many technology needs. It's ready for audits and flexible for re-consenting. This platform offers secure eConsent services, pushing clinical research forward with safe and legal solutions. They've worked with over 400 sponsors and CROs, including all Top 20 pharmaceutical companies.
How does Science 37 facilitate eConsent for decentralized trials?
Science 37 has innovative eConsent for decentralized trials. It supports remote consent through telehealth and uses multimedia to educate participants. This makes trials more inclusive and focused on what participants need.
What is the expected growth of the eConsent software market?
The eConsent software market is expected to reach USD 996.6 million by 2031. This growth shows increasing adoption of digital consent platforms. Cloud solutions and general consent are expected to grow fast, especially in North America and Europe.
Conclusion
Thanks to technology, the clinical trials landscape is changing at an unprecedented speed. Electronic informed consent is pivotal in making trials smoother, streamlining the experience for participants, and following the rules. We've navigated the top 10 digital consent platforms that lead the way in this new area.
These platforms make it easier for people to understand what they're agreeing to by using simple interfaces and the latest tech. In addition, they make it easier for more people to join trials. With secure digital signatures and tracking in real-time, they help follow the rules better. This helps solve many problems that clinical trial teams face.
Integrating these digital consent platforms makes clinical trials more efficient and successful. It helps us meet the needs of participants, move science forward faster, and keep up with strict rules. As we keep finding new ways to enhance, eConsent will be a big part of the future of clinical research.
Whether you're looking for decentralized trial capabilities like MILO Healthcare, comprehensive platform solutions like Medidata, or regulatory compliance excellence like Veeva, there's an eConsent platform designed to meet your specific clinical trial needs.
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