In clinical research, centers face numerous challenges in managing processes, data, and regulations. An ERP-CRM solution like Trial 360, based on the robust Odoo platform, provides essential tools to address these issues and improve operational efficiency, traceability, and regulatory compliance.
Main Challenges and Solutions with Trial 360
1. Disorganized Clinical Trial Management
- Pain: Managing studies using multiple systems or manual tools (Excel, physical documents) leads to data duplication, errors, and disorganization.
- Solution with Trial 360 on Odoo: Centralize all clinical trial information in a single system, with controlled access, and in real-time.
2. Difficulties in Regulatory Documentation Management (eReg)
Pain: Manual control of regulatory documents, informed consents, and audits, with risk of regulatory non-compliance (GCP, FDA, EMA).
Solution with Trial 360 on Odoo: Document management modules with approval flows, electronic signature, and audit of changes, ensuring compliance and traceability.
3. Problems in Recruitment and Patient Management
- Pain: Difficulties attracting participants through digital channels, recruitment, monitoring their complete cycle (screening, enrollment), and retention.
- Solution with Trial 360 on Odoo: CRM adapted to clinical recruitment, integrated with digital marketing tools for multi-channel campaigns.
4. Inefficient management of visits, consultation times, and high risk of non-compliance with the delegation log.
- Pain: Errors in managing visits and their windows, difficulty rescheduling, control of absences, and management of capacity versus demand. Deviations due to non-compliance with the Delegation Log and updates.
- Solution with Trial 360 on Odoo: Automating scheduling according to protocol, time control by status, electronic delegation log, and controlled access according to role and responsibility.
5. Lack of Financial Control and Billing and Payment Management (eFinancials)
- Pain: Complexity in managing payments to suppliers and participants, which can generate errors and delays. Long time between execution and billing to Sponsors/CROs. Increased portfolio and cash flow risk.
- Solution with Trial 360 on Odoo: Automation of payments, budget tracking by study, billing control, and bank reconciliation. Pre-billing and automatic billing to sponsors/CROs by visit or procedures. Integration with accounting and integrated financial governance.
6. Inefficient source document management due to paper (eSource)
- Pain: Inefficiency, rework, and risk of not capturing data according to protocol.
- Solution with Trial 360 on Odoo: eSource organized by study, visit, and procedure. It is fully integrated with laboratory, imaging, and pharmacy.
7. Poor Inventory and Supplies Management
- Pain: Lack of visibility in the availability of clinical supplies (kits, samples, reagents) and risk of shortages.
- Solution with Trial 360 on Odoo: Real-time inventory control, low stock alerts, and full traceability of supplies used in the study.
8. Lack of Coordination between Teams and Sites
- Pain: Lack of communication between coordinators, researchers, and administrative staff, especially in multi-center studies.
- Solution with Trial 360 on Odoo: Collaborative tools, shared calendar, and integrated task management.
9. Long Study Startup Times
- Pain: Delays in the startup phase due to lack of coordination and visibility of critical tasks (contracts, IRB/EC approvals).
- Solution with Trial 360 on Odoo: Project management with milestones and automated tasks for each study phase.
10. Difficulty Generating Reports and Metrics (Study KPIs)
- Pain: Manual generation of performance reports, making it difficult to make informed decisions.
- Trial 360 solution on Odoo: Customizable dashboards with key metrics such as enrollment rates, deviations, and schedule compliance.
11. Compliance with Good Clinical Practices (GCP)
- Pain: Risk of not complying with GCP regulations due to manual processes, failure to send SAE, AE, etc. reports to regulatory entities.
- Solution with Trial 360 on Odoo: Automating document flows, version control, and auditable electronic records. PI Oversight and an internal record for monitoring and controlling findings and deviations. Integrated reports with filters for SAEs, AEs
Additional Benefits
- Remote Monitoring and Collaboration: Tools for real-time monitoring of studies and equipment.
- Automation and Time Saving: Reduction of repetitive manual tasks, allowing staff to focus on higher-value activities.
- Guaranteed Regulatory Compliance: Complying with international standards is easier thanks to traceability and auditable records.
- Scalability and Modularity: Odoo allows you to start with basic modules and expand as needed.
- Centralization: All processes and data in a single system.
- Complete Traceability: Detailed record of each action.
- Better Decision Making: Real-time data and automatic reports.
- Savings in time and money.
- Return on Investment.
Benefits of having Odoo as the basis of Trial 360:
- Avoid Reinventing the Wheel:
– With proven solutions, Odoo already solves standard problems such as inventory management, invoicing, accounting, and CRM.
– Instead of developing from scratch, you can focus on customizations and extensions specific to the business. - Speed of Implementation:
– Implementing Odoo is faster than developing software from scratch.
– The time saved translates directly into lower opportunity costs and a faster go-to-market. - Error Reduction and Maintenance:
– A proven ERP like Odoo minimizes common development errors and provides continuous updates.
– Less time spent fixing bugs = more focus on business innovation. - Scalability and Modularity:
– Odoo grows with the business: you can start with basic modules and expand as needed.
– There is no need to redesign the entire system as the company grows. - Focus on Core Business:
– By delegating operational management to Odoo, the company can focus on what adds value. - Access to Best Practices:
– Odoo incorporates processes based on industry standards, allowing the adoption of best practices without reinventing them. - Global Solution with Multi-Language, Multi-Country, Multi-Currency, and Multi-Company:
– Odoo is used by more than 12 million users worldwide in different languages, currencies, and business schemes.
Clinical research centers face complex challenges that can slow their operations, increase costs, and compromise regulatory compliance. Trial 360 on Odoo offers a comprehensive solution that efficiently addresses each of these challenges. From centralizing study management and automating critical processes to optimizing documentation, recruitment, and finances, Trial 360 not only improves operational performance but also enables centers to focus their resources on scientific innovation and clinical excellence.
With advanced tools and a modular and scalable approach, this solution solves current problems and prepares centers to face future challenges, ensuring sustainability and success in an increasingly competitive and regulated environment.
Discover how Trial 360 can transform your clinical research center today!
