Complete Digital Presence Package
For Clinical Research Organizations, Sponsors, Research Sites & Academic Institutions
Study Management • Participant Management • Regulatory Compliance • Analytics & Reporting • Social Media Marketing
Clinical Research Management System Features
👨⚕️ Investigator Management
- Investigator Profiles
- Staff & Role Management
- Training & Certification Records
- Credential Expiry Tracking
- Investigator Communication
🏥 Site Management
- Research Site Database
- Site Qualification & Selection
- Site Activation Tracking
- Site Performance Monitoring
- Site Communication Portal
📋 Study Management
- Create & Configure Clinical Studies
- Protocol & Amendment Management
- Study Timeline & Milestones
- Multi-Center Study Support
- Study Status Dashboard
👥 Participant Recruitment
- Volunteer Database
- Recruitment Campaign Management
- Eligibility Screening
- Enrollment Tracking
- Recruitment Analytics
🧑 Subject Management
- Participant Profiles
- Visit Scheduling
- Medical History Records
- Visit Status Tracking
- Follow-Up Management
✍️ eConsent Management
- Digital Consent Forms
- Electronic Signatures
- Consent Version Control
- Consent Audit Trail
- Participant Consent History
🗄️ Electronic Data Capture (EDC)
- Electronic Case Report Forms (eCRF)
- Secure Data Entry
- Automated Validation Rules
- Query Management
- Data Export & Reporting
📁 Trial Master File (eTMF)
- Centralized Document Repository
- Version Control
- Essential Document Tracking
- SOP Management
- Inspection-Ready Documentation
📜 Regulatory Management
- IRB / IEC Submission Tracking
- Ethics Approval Management
- Regulatory Document Repository
- Submission History
- Renewal & Expiry Alerts
🔍 Monitoring & CRA Management
- Monitoring Visit Scheduling
- Site Visit Reports
- Action Item Tracking
- Follow-Up Letters
- Risk-Based Monitoring Dashboard
🛡️ Safety & Pharmacovigilance
- Adverse Event (AE) Reporting
- Serious Adverse Event (SAE) Management
- Safety Notifications
- Medical Review Workflow
- Case Tracking Dashboard
💊 Drug Accountability
- Drug Inventory Tracking
- Randomization Support
- Kit Assignment
- Drug Dispensing Records
- Return & Destruction Logs
📅 Visit Management
- Participant Visit Calendar
- Appointment Scheduling
- Visit Reminders
- Missed Visit Tracking
- Visit Completion Reports
🧪 Laboratory Management
- Sample Collection Tracking
- Laboratory Result Integration
- Specimen Management
- Test Status Monitoring
- Lab Report Repository
💰 Financial Management
- Study Budget Management
- Investigator Payments
- Site Payment Tracking
- Invoice Management
- Financial Reporting
📊 Reports & Analytics
- Enrollment Dashboard
- Study Progress Reports
- Site Performance Analytics
- Compliance Reports
- Executive KPI Dashboard
✅ Compliance & Audit
- Audit Logs
- 21 CFR Part 11
- GCP Compliance
- Role Permissions
- Inspection Readiness
🚀 Social Media Marketing Services
Complete Setup
LinkedIn, Website Profiles, Research Directories & Digital Channels with Consistent Clinical Branding
Content Creation
Clinical Research Awareness Content, Study Insights, Healthcare Articles & Educational Materials
Engagement
Build Trust & Strengthen Relationships with the Clinical Research Community
Reputation Management
Enhance Trust, Credibility & Industry Recognition
Targeted Ads
Reach Sponsors, CROs, Researchers & Healthcare Decision Makers
Analytics
Track Digital Growth, Engagement & Business Opportunities
Optional Premium Add-ons
🔄 CTMS Integration
- Sponsor Integration
- Clinical Trial Synchronization
- Workflow Automation
- Data Exchange
📝 eSource
- Electronic Source Documentation
- Digital Medical Notes
- Source Verification
- Electronic Record Management
📱 ePRO / eCOA
- Patient Reported Outcomes
- Mobile Surveys
- Remote Assessments
- Digital Questionnaires
🧪 Laboratory Integration
- Lab Information System Integration
- Automated Result Import
- Sample Tracking
- Test Management
🔌 API Integration
- Third-Party APIs
- Hospital Information Systems
- ERP Integration
- CRM Integration
Why Choose Our Package?
📊 Real-Time Operational Visibility
Monitor recruitment progress, site performance, financials, compliance status, and study milestones through interactive dashboards and reports.
🛡️ Regulatory Compliance
Designed to support FDA, EMA, ICH-GCP, HIPAA, GDPR, and 21 CFR Part 11 compliance with comprehensive audit trails and secure electronic records.
🌐 End-to-End Digital Solution
Manage the complete clinical research lifecycle from study planning and participant recruitment to monitoring, reporting, and study closeout within a single integrated platform.
Ready to Transform Your Clinical Research?
Digitize your clinical operations, improve collaboration across research teams, ensure regulatory compliance, and gain real-time visibility into every study from a single centralized platform.
Contact us to discuss your custom requirements
Building trust through digital excellence
websitedemo@kalgisoft.com