Development Strategy & Scientific Analysis
Strategic guidance on study design, endpoint selection, and development pathway. Leverage our experience across therapeutic areas and study phases.
Full-Service CRO
Everything you need. One accountable partner.
From protocol development to database lock—clinical operations, site management, technology, and regulatory support delivered under one roof.
Traditional trials require sponsors to coordinate multiple vendors, manage integrations, and chase accountability across fragmented teams. Validcare delivers all CRO services through a single, integrated partnership—with transparent pricing and real-time visibility.
One partner means one point of accountability
When your trial spans multiple vendors, every handoff creates risk. Data silos form. Finger-pointing begins. Problems escalate slowly. Timelines slip.
Fragmented Approach
- CRO for clinical operations
- Separate EDC vendor
- Different CTMS system
- Third-party recruitment
- External data management
- Multiple contracts, multiple invoices
- No single source of truth
- Accountability gaps
Validcare Full-Service
- One partner for all services
- Integrated SmartSource™ platform
- Unified data from day one
- Coordinated recruitment
- Continuous data management
- Single contract, transparent pricing
- Real-time visibility
- Clear accountability
Full-service isn't about doing everything. It's about owning everything—so you don't have to.
Comprehensive capabilities from planning through submission
Validcare provides the full spectrum of clinical trial services. Every capability integrated. Every team aligned to your timeline and budget.
Planning & Design
Get your trial started right—with protocols optimized for success and regulatory pathways cleared.
Protocol Development
Write or refine your protocol to optimize for primary endpoint collection, electronic source data capture, and regulatory acceptance.
Feasibility & Site Selection
Comprehensive feasibility assessment across countries, regions, and sites. Select sites based on data, not relationships.
Regulatory Support & Submissions
IND/IDE preparation, IRB/Ethics Committee management, regulatory submissions, and ongoing agency correspondence.
Risk Assessment & Management
Identify and mitigate trial risks before they become problems. Proactive monitoring throughout study execution.
Technology & Data
SmartSource™ powers every Validcare trial—capturing data at the source and giving you real-time visibility.
SmartSource™ Platform Setup
Configure our unified clinical trial platform for your specific protocol. Role-based access, automated workflows, and real-time reporting.
Direct Source Data Capture
Capture clinical data directly from investigators and patients—eliminating transcription errors, SDV visits, and query cycles.
EDC / eCRF
Electronic data capture with real-time edit checks, query management, and complete audit trail.
ePRO / eCOA
Patient-reported outcomes and clinical outcome assessments captured directly on mobile devices.
eConsent
Electronic informed consent with version control, 24/7 audit trail, and multi-language support.
Randomization / IRT
Interactive response technology for treatment assignment, stratification, and drug supply management.
Clinical Operations
Experienced teams managing your trial day-to-day—with proactive communication and real-time visibility into site performance.
Clinical Trial Management
End-to-end project management from kick-off through database lock. Dedicated team assigned to your trial.
Site Start-Up
Centralized collection of regulatory documents, SIV training, and site activation. Get sites enrolling faster.
Clinical Monitoring
Risk-based monitoring powered by real-time data. Central monitoring identifies issues before they escalate.
Medical Monitoring
Physician oversight of safety data, protocol questions, and medical decisions.
Patient Recruitment & Engagement
Integrated digital recruitment, prescreening, and screening workflows. Track source of every participant.
Site Payments
Investigator payment tied to source data entry. Real-time participant eReimbursement at end of each visit.
Data Management & Biostatistics
Continuous data cleaning throughout your study—not a backlog at the end. Database lock in days, not months.
Data Management
Centralized collection, monitoring, and query management. Continuous cleaning throughout study.
Query Management
Real-time query generation and resolution. Direct source data capture means significantly fewer queries.
Database Lock
LPLV to DBL achieved in days or weeks—not months. Clean, audit-ready data in your preferred format.
Biostatistics
Statistical analysis plan development, interim analyses, and final statistical reports.
Medical Writing
Clinical study reports, regulatory submission documents, and publications support.
Safety & Quality
Integrated safety management and quality assurance throughout your trial.
Pharmacovigilance & Safety Management
AE/SAE capture, assessment, and reporting integrated into SmartSource™ workflows.
Protocol Deviation Management
Proactive alerting and documentation of protocol deviations. Root cause analysis and CAPA management.
Quality Assurance
Audit support, inspection readiness, and continuous quality monitoring. GCP compliance built in.
What's included with Validcare Full-Service
| Capability | Validcare | Traditional CRO | Clinical Tech Vendor | Recruitment Vendor |
|---|---|---|---|---|
| Trial Management | — | — | ||
| Protocol Development | — | — | ||
| Regulatory Support | — | — | ||
| Site Selection & Start-Up | — | — | ||
| Clinical Monitoring | — | — | ||
| eClinical Platform | — | — | ||
| Direct Source Data Capture | — | — | — | |
| Patient Recruitment | Partial | — | ||
| Data Management | Partial | — | ||
| Biostatistics | — | — | ||
| Safety / PV | — | — | ||
| Medical Writing | — | — | ||
| Performance-Based Contracts | — | — | — | |
| Real-Time Sponsor Dashboards | — | Partial | — |
Performance-Based
Performance-based contracting that aligns our success with yours
Traditional CRO contracts reward inefficiency. Hourly billing. Change orders. Pass-through markups. Validcare structures contracts differently.
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 simple admin fee
- No "project management" catch-all line items
Risk-Sharing Options
- Partial payment in equity of sponsor's company
- Shared risk on enrollment rates
- Milestone-based payments tied to study milestones
Supporting trials across phases and modalities
Phases I-III
First-in-human through pivotal trials. Single-site to global multi-center studies.
Medical Device Studies
IDE submissions, pivotal trials, and post-market studies.
Nutraceutical & Food Studies
Infant formula, dietary supplements, and functional food studies.
Real-World Evidence
Observational studies, registries, and post-market surveillance.
Decentralized & Hybrid Trials
Remote consent, home-based visits, and virtual site solutions.
Frequently Asked Questions About Full-Service CRO
What does a full-service CRO actually include?
A full-service CRO manages every aspect of your clinical trial under a single contract—from protocol development and regulatory submissions through site selection, patient recruitment, clinical monitoring, data management, biostatistics, and medical writing. At Validcare, full-service also includes our proprietary SmartSource platform for direct source data capture, electronic consent, ePRO, randomization, and real-time sponsor dashboards. The key difference from traditional CROs is integration: instead of coordinating five to seven separate vendors for EDC, CTMS, recruitment, and data management, you get one accountable team with unified technology. This eliminates the handoff risks, data silos, and finger-pointing that plague multi-vendor trials.
How does Validcare's pricing differ from traditional CRO contracts?
Traditional CRO contracts typically use unit-based or hourly billing that rewards inefficiency—the longer your trial runs and the more queries generated, the more they bill. Validcare uses fixed-fee contracts for setup and monthly study management. Pass-through costs are transparent with a simple admin fee, and there are no catch-all 'project management' line items that inflate over time. We also offer risk-sharing options including equity participation, shared risk on enrollment milestones, and performance-based payment structures. This model aligns our incentives with yours: we succeed when your trial succeeds on time and on budget.
How does direct source data capture reduce trial timelines?
In traditional trials, investigators record data on paper source documents, then site staff transcribe it into an EDC system. Every transcription introduces potential errors, which generate queries that take weeks to resolve. CRAs must also travel to sites for source data verification (SDV) visits. Validcare's SmartSource platform eliminates this entire cycle by capturing data directly from investigators and patients at the point of care. Because source data is the EDC data, there is no transcription, no transcription errors, and no SDV visits required. The result is significantly fewer queries, continuous data cleaning throughout the study, and database lock achieved in days after last patient last visit—not the weeks or months typical of traditional approaches.
What therapeutic areas and study phases does Validcare support?
Validcare supports clinical trials across phases I through III, medical device studies (IDE and post-market), nutraceutical and food studies (including infant formula and dietary supplements), real-world evidence studies, and decentralized or hybrid trial designs. Our expertise includes more than 20 therapeutic areas across life sciences and medical devices, including dermatology, gastroenterology, cardiology, pain management, metabolic disorders, and more. We work with biotech startups running their first-in-human study as well as established sponsors managing multi-center global programs. Our integrated platform and experienced team adapt to your protocol requirements regardless of therapeutic area or study complexity.
How much sponsor oversight and visibility will I have during my trial?
Validcare provides real-time visibility into every aspect of your trial through live SmartSource dashboards—not monthly PDF reports compiled from stale data. Sponsors have role-based access to enrollment tracking, screening-to-enrollment funnels, data quality metrics, query rates by site and form, AE/SAE summaries, budget versus actual spending, milestone achievement, and site performance comparisons. You also get direct access to experienced Validcare team members and executives who stay engaged throughout the trial, not just during the sales cycle. Our study roadmap ties every milestone to your budget and timeline, so you always know exactly where your trial stands and what comes next.
Can Validcare run decentralized or hybrid clinical trials?
Yes. Validcare's SmartSource platform was designed for flexible trial designs including fully decentralized, hybrid, and traditional site-based models. For decentralized elements, SmartSource supports remote electronic consent, patient-reported outcomes captured on mobile devices, home-based visit coordination, and virtual site solutions. For hybrid designs, you can mix in-person site visits with remote data collection seamlessly within the same platform. All data—whether captured at a physical site, at the patient's home, or on a mobile device—flows into a single unified database with the same audit trail, edit checks, and real-time reporting. This flexibility lets you optimize your trial design for patient convenience and enrollment speed without sacrificing data quality or regulatory compliance.
Let's Get Started
Ready to experience full-service done right?
Tell us about your trial. We'll show you how Validcare delivers—with transparent pricing and a clear timeline.