Contracting
What they promise:
Competitive pricing
What you get:
Low-ball offers followed by significant, frequent change orders that reward poor CRO performance
An exceptional experience from protocol to database lock
Traditional CROs promise speed—then deliver excuses. Validcare aligns incentives, captures clean data at the source, and gives you real-time visibility into your trial.
The Reality
You deserve better than excuses and change orders
Clinical operations leaders know the frustration. You've heard it before—and you've lived it.
Timelines
What they promise:
Aggressive schedules
What you get:
CRO-dictated timelines that slip without accountability
Executive Access
What they promise:
Senior involvement
What you get:
Executives who appear during the sale, then disappear
Source Data
What they promise:
Data quality
What you get:
Siloed data requiring manual verification, transcription errors, and endless query cycles
Visibility
What they promise:
Transparency
What you get:
Black-box operations with no real-time visibility into site activities or performance
Issue Management
What they promise:
Proactive support
What you get:
Understaffed, inexperienced team members who lack urgency and early warning capabilities
You're running out of runway. An exceptional experience exists—but it requires a new approach.
The Validcare Difference
The Validcare Difference
An exceptional, tailored experience from planning through database lock.
Transparent Contracting
Transparent contracting aligned with your budget—not CRO revenue. Predictable, fixed fees for setup and monthly management. No "project management" catch-all line items.
Realistic Flight Plan
CRO timelines tied to a dynamic, protocol-specific Flight Plan by country and site. Milestones you can track in real time.
Hands-On Executives
Hands-on involvement by executives throughout your trial—from protocol optimization to regulatory submission. Not just during the sales cycle.
Direct Source Data
Centralized, real-time source data collection across all sites. Data captured at the point of care flows directly to your database—clean, complete, and audit-ready.
Real-Time Visibility
Real-time visibility, control, and reporting over all clinical operations, workflows, and data. Your trial, your dashboard, your decision-making.
Proactive Issue Management
Proactive issue management by experienced, critical-thinking team members. Problems identified early. Solutions delivered fast.
How We Work
Agree on a realistic Flight Plan
Aligned with financial and operational metrics from day one
Every Validcare trial follows a Flight Plan—a dynamic, protocol-specific roadmap that ties milestones to your budget and timeline. No surprises. No hidden costs. Complete visibility from takeoff to landing.
1
Preflight Planning
Protocol Finalization
2
Taxiing Configuration
Platform Setup
3
Takeoff Contracting
Site Selection
4
Departure Go-Live
Site Activation
5
In Flight Active
Patient Screening, Enrollment & Visits
6
Descent & Approach Cleaning
Continuous Data Management
7
Landing Complete
Database Lock
What happens at each phase
Detailed deliverables and milestones for every stage of your trial
Phase 1 Preflight
Protocol Finalization
Preflight
Protocol FinalizationWe write and/or edit your protocol to optimize for success.
Deliverables:
- Protocol optimized for collecting primary endpoint data
- Language aligned for electronic source data collection, monitoring, and reporting
- Appropriate inclusion/exclusion criteria and secondary metrics
- Reasonable participant participation requirements
- Assumptions validated against market feasibility feedback
IRB/Ethics Committee management included.
Phase 2 Taxiing
Platform Setup & Configuration
Taxiing
Platform Setup & ConfigurationSmartSource™ is configured specifically for your study.
Deliverables:
- Access rules and permissions by role (investigator, sponsor, CRO, participants, vendors, PV team)
- Automated workflows (site survey, activation, regulatory, recruitment, consent, visits, AE/SAE, monitoring, queries)
- Investigator training and digital binder configuration
- Real-time site reports (approvals, participant diaries, visits, lab results, schedules)
- Real-time sponsor reports (recruitment, enrollment, AE/SAEs, protocol deviations, site performance, metrics)
Phase 3 Takeoff
Site Selection
Takeoff
Site SelectionWe identify and contract the right sites for your study.
Deliverables:
- Feasibility assessment (countries, regions, sites, competitive studies, standard of care, patient population)
- Site survey composition and execution
- Site selection based on survey results, sponsor input, and budget
- Performance-based site contracts aligned with Flight Plan
Phase 4 Departure
Site Activation
Departure
Site ActivationSites go live with centralized regulatory management.
Deliverables:
- Centralized collection of regulatory documents
- SIV training completed
- Site activation confirmed
- All systems tested and operational
Phase 5 In Flight
Patient Screening, Enrollment & Visits
In Flight
Patient Screening, Enrollment & VisitsPatients are recruited, enrolled, and managed through study visits.
Deliverables:
- Automated prescreening and screening (at-home or in-office)
- Integration with 3rd party recruitment vendors or investigator practice
- Integrated eConsent with 24/7 visibility
- System-generated study IDs based on randomization
- Real-time alerts, reminders, and instructions per task
- Data collected directly from participants (ePRO, medical history, AE/SAEs)
- Proactive monitoring and alerts for queries, AE/SAEs
- Real-time participant eReimbursement at end of each visit
- Elimination of paper at site and source data verification (SDV)
Phase 6 Descent & Approach
Data Management
Descent & Approach
Data ManagementData is continuously cleaned throughout the study—not just at the end.
Deliverables:
- Centralized collection, monitoring, and queries with full audit trail
- Proactive alerting and documentation of Protocol Deviations
- Real-time access to patient journey
- Real-time AE/SAE/Pharmacovigilance management and reporting
- Continuous data cleaning throughout study
Phase 7 Landing
Database Lock
Landing
Database LockLast Patient Last Visit to Database Lock achieved in days—not weeks or months.
Deliverables:
- Database lock within days of LPLV
- Reduced time to study report and regulatory submissions
- Sponsor receives entire database in preferred format
- Sites receive only their subset of data
- Audit-ready documentation
Performance-Based
Performance-based contracting aligned with your goals
Traditional CRO contracts reward the wrong behavior. Hourly billing incentivizes inefficiency. Change orders punish you for their problems. Validcare structures contracts to align our success with yours.
Fixed Fees
- Predictable, fixed fee for setup and monthly study management
- Fixed fee for statistical analysis and study write-up
- Transparent pass-through costs with admin fee (no "project management" catch-all)
Risk-Based Options
- Partial payment in equity of sponsor's company
- Shared risk on enrollment rates
- Milestone-based payments tied to Flight Plan
Ready to Start?
Are you ready for an exceptional CRO experience?
Let's discuss your trial. We'll walk you through the Flight Plan approach and show you exactly how Validcare delivers faster, cleaner results.