The typical implementation process for eClinPro CTMS & eSource software:
Initial Consultation & Needs Assessment: Discuss site requirements, existing workflows, and study specifics to customize the implementation approach.
System Configuration & Customization: Set up account, user permissions, and tailor modules (CTMS, eSource, etc.) to meet study protocols and site needs.
Data Migration (if needed): Import study data, templates, and existing documentation from legacy systems or spreadsheets.
User Training: Provide remote or self-guided training using help resources, video tutorials, and live support to ensure all team members are prepared.
Validation & User Acceptance Testing: Review platform setup with end users, validate workflows, and confirm that customized templates and processes function as designed.
Go-Live: Official system launch for study activities, including ongoing access to support for troubleshooting and optimization.
eClinPro CTMS & eSource can be extensively customized to fit specific business needs across research sites, CROs, and sponsors.
Custom Source Design: Clients can request bespoke eSource templates, defining structure, colors, initials, and signature fields. Each study may have unique case report forms, workflows, and data capture requirements.
Workflow Customization: The platform can accommodate user-specific workflows, such as trial design, protocol calendars, visit scheduling, and tailored recruitment modules.
Form and Report Customization: Users can design and manage customized forms and reports, including eCRF (electronic case report forms), eDocs, and patient tracking documents—allowing sites to adapt documentation to protocol specifics.
Role-Based Permissions: User management and permissions can be configured based on business processes, supporting clinical roles, administrative staff, and sponsors' operational needs.
Integrations: eClinPro integrates with third-party solutions (e.g., for patient recruitment, SMS reminders, EMR/EHR, and web advertising), giving organizations flexibility in extending the platform.
Automated Alerts & Notifications: Expiry alerts for documents, calendar reminders, and SMS communications can be customized to specific site policies and patient engagement strategies.
Rapid Deployment: Personalized implementations, rapid onboarding, and template design can be delivered in 1-2 weeks, customized for the specifics of each research protocol.
Feedback Implementation: A key benefit cited by users is responsiveness to customization requests; most ideas and workflow adaptations from clients are rapidly adopted into the product.
Multilingual Support: Some sites have requested master documents and eConsent in languages other than English, showing flexibility in localization.
Financial and Reporting Customization: Custom budget tracking, stipend payments, and reporting conform to each organization’s unique contracting and payments workflows.
eClinPro CTMS & eSource has a transparent pricing structure, but additional costs may apply depending on specific usage and optional features.
Subscription fee: Starts at $250 per month (flat rate) for the basic plan, which typically includes CTMS, eSource, eDocs, dynamic reports, and unlimited users and text appointment reminders.
Free trial: Available for new users to evaluate the system.
Setup fees: No public indication of mandatory setup fees for standard deployment, rapid implementation (1-2 weeks) is generally included for most plans.
Module fees: Certain advanced modules (e.g., Mass SMS campaigns, web advertising, specific integrations) may incur separate charges or require additional purchases, as mentioned in the service descriptions.
Text message campaigns: Appointment reminders are included, but mass SMS for recruitment are billed separately depending on usage volume.
Long-term storage: For small business plans and above, fees for long-term document storage and regulatory archiving are waived; base plans may require additional charges.
Document uploads: Electronic document management, signatures, and certified copy uploads are included; no listed extra fees for typical usage.
User support: Email, phone, chat, help desk, and knowledge base support are covered at no additional charge within all regular subscription plans.
eClinPro CTMS & eSource offers a versatile range of training and support options for new users, ensuring a smooth onboarding and ongoing assistance experience.
In-Person Training: Available for sites that prefer hands-on learning with trainers at their location.
Live Online Training: Interactive webinars and remote sessions with eClinPro experts.
Self-Guided Tutorials: Accessible documentation and video guides for step-by-step instructions on platform usage.
CRC Academy Training Platform: Dedicated environment for practicing workflows and familiarizing staff with the tools before going live.
Continuous Educational Resources: On-demand help center, FAQs, and knowledge base materials for ongoing learning.
Email, Phone, and Chat: Responsive support team available via multiple channels for system questions, troubleshooting, and workflow optimization.
Help Desk and Customer Service: Direct access to customer support for technical issues and best practice guidance.
eClinPro CTMS & eSource employs a robust suite of security measures and compliance certifications to protect clinical research data at every stage.
Data Encryption: Uses AES-256-bit encryption for data at rest and in transit to prevent unauthorized access.
Regulatory Compliance: Fully compliant with HIPAA, HITECH, SOC2, SOC3, and 21 CFR Part 11—ensuring adherence to industry best practices for data integrity, privacy, and electronic records.
Two-Factor Authentication (2FA): Requires an additional verification step at login for all users to reduce the risk of unauthorized access.
IP Address Restrictions: Allows only approved IP addresses to access the system for heightened perimeter security.
Audit Trails: Maintains detailed, immutable audit logs for every action, including login, data creation/editing, eSignatures, and data access—critical for compliance and incident review.
Role-Based Permissions: Access controls restrict user capability based on assigned roles, ensuring minimum necessary data exposure.
Dedicated Infrastructure: Runs on secure, isolated cloud environments with regular vulnerability assessments and system monitoring.
Disaster Recovery & Backups: Daily onsite and offsite automated backups, with data mirrored across multiple geographic regions to guarantee high availability and data recoverability for up to 30 days.
Continuous Monitoring: Supported by a dedicated cybersecurity team, with partnerships to ensure resilient hosting and prompt threat detection and mitigation.
Staff Training and SOPs: Staff members are regularly trained in security protocols, and the system is governed by strict Standard Operating Procedures for privacy and operational security.
eClinPro CTMS & eSource regularly issues software updates with ongoing improvements, compliance updates, and user-requested features. Updates are managed centrally and rolled out to all users, minimizing disruption.
Continuous Improvement: eClinPro operates as a cloud-based platform, allowing for frequent updates—often monthly or quarterly—depending on the release schedule and client needs.
Security & Regulatory Changes: Critical patches and compliance-related enhancements are prioritized and applied as soon as needed to maintain 21 CFR Part 11, HIPAA, and other industry standards.
New Features: User-requested functionalities and workflow improvements are added incrementally, supporting an agile and user-responsive release cycle.
Centrally Managed Deployment: All updates are deployed on the server/cloud infrastructure, so users do not need to manually install patches or new versions.
Minimal Disruption: Updates are typically scheduled during off-peak hours and communicated in advance, ensuring that research activities are not interrupted.
Automatic Access to Improvements: All sites and users receive the latest features, bug fixes, and security enhancements automatically as part of their subscription.
eClinPro CTMS & eSource has a client-centric policy on data ownership and portability, meaning organizations retain full ownership of their data and have the ability to export or migrate it as needed.
All data entered or managed within eClinPro CTMS & eSource is owned by the client (the research site, sponsor, or CRO).
Clients have legal and operational control over their data, which includes subject records, study documentation, financial data, and audit logs.
The platform supports data import and export functionalities, enabling organizations to quickly transfer records in standard formats (CSV, Excel, XML, SPSS, etc.).
Data export can be performed for both study data and trial master files, allowing seamless migration to other platforms or backup systems.
If a site transitions to another CTMS, eClinPro provides all its data in a usable format, facilitating business continuity and regulatory compliance.
Document management features allow users to download certified copies, signed records, reports, and patient data as needed.
Data portability complies with regulations such as HIPAA and 21 CFR Part 11, ensuring secure transfer and ongoing access to proprietary information.
eClinPro CTMS & eSource offers flexible terms for scaling up or down with organizational needs, allowing seamless adjustment as study volume, users, or business size changes.
Subscription Flexibility: The subscription model is month-to-month, supporting easy upgrades or downgrades at any time—clients can adjust their plan as the number of active studies, users, or required modules increases or decreases.
No Long-Term Commitment: No extended contract is required, so organizations can increase or reduce scope without penalty or delay.
Adding Users or Studies: Higher-tier plans (e.g., Small Business and above) support unlimited users and sites, making it straightforward to scale for multi-site or high-volume operations.
Switching Plans: Clients can transition between plans (e.g., from Startup to Small Business or Business Plan) as their research portfolio grows or contracts, with billing adjusted accordingly.
Support for All Organization Sizes: The platform is specifically designed to serve small, medium, and large research organizations, offering key modules for each scale of operation.
No Migration or Setup Delays: Implementation for new studies or added users can be accomplished quickly (1-2 weeks for setup and onboarding), minimizing operational downtime.
eClinPro CTMS & eSource offers flexible and client-friendly terms for contract renewal and cancellation, focusing on transparency and adaptability for clinical sites and sponsors.
Subscription Model: Services are provided on a monthly subscription basis,
No Long-Term Commitment Required: Most plans do not require long-term contracts, allowing clients to pay monthly and scale up/down based on changing study needs.
Cancellation Policy: Clients can cancel their subscription without penalty, usually by providing written notice before the start of the next billing cycle. There are no mandatory cancellation fees for standard plans.
Renewal Process: Subscriptions typically auto-renew every month unless the client submits a cancellation request.
Upgrade/Downgrade Flexibility: Clients may upgrade or downgrade their plans at any time, depending on the number of studies or users required.
Data Return Upon Cancellation: Upon termination, the client has the right to export or receive all of their data in a standard format, ensuring data portability and no vendor lock-in.
No Hidden Fees: Pricing is transparent, with clearly stated subscription costs and any optional additional charges communicated upfront.
Support for Transition: The vendor supports data migration or export during offboarding to facilitate business continuity for departing clients.
eClinPro CTMS & eSource meets the stringent compliance standards required for clinical research and healthcare data management.
21 CFR Part 11: Fully compliant with FDA regulations for electronic records and electronic signatures, supporting audit trails, data security, time-stamping, and integrity of clinical trial documentation and eCRFs.
HIPAA (Health Insurance Portability and Accountability Act): Ensures confidentiality, security, and privacy of protected health information in the U.S. healthcare and research context.
HITECH: Adheres to the Health Information Technology for Economic and Clinical Health Act for enhanced privacy and data breach notification requirements.
SOC2 and SOC3: Certified for SOC2 and SOC3 standards—including controls for security, availability, processing integrity, confidentiality, and privacy of data, as defined by the American Institute of CPAs.
Data Encryption: Implements AES-256-bit encryption for data at rest and in transit, in line with international security best practices.
Audit Trails: Maintains comprehensive, immutable audit records for all system and data activities.
All eSource and eDocs modules are built for real-time data entry and validation, reducing protocol deviations and transcription errors.
Electronic signatures and certified document uploads provide both regulatory and operational assurance.
Secure cloud infrastructure and daily backups support disaster recovery, redundancy, and business continuity.
eClinPro CTMS & eSource
By eClinPro LLC
