The Performance-Based CRO for the real-time clinical trial.

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 the SmartSource™ Clinical Trial Platform — Source Data Collection at the point of care, electronic consent, ePRO, randomization, and protocol-governed real-time access for every stakeholder. 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.

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.

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. The SmartSource™ Clinical Trial Platform eliminates this entire cycle through Source Data Collection — clinical data captured directly from investigators and participants at the point of care. Because source data is the EDC data, there is no transcription, no transcription errors, and SDV scope collapses dramatically. The result is significantly fewer queries, Continuous Cleaning throughout the study, and database lock achieved in days after last patient last visit — not the weeks or months typical of traditional approaches.

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.

Validcare provides real-time visibility into every aspect of your trial through the SmartSource™ Clinical Trial Platform — not monthly PDF reports compiled from stale data. Sponsors have role-based, protocol-governed 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.

Yes. The SmartSource™ Clinical Trial Platform was designed for flexible trial designs including fully decentralized, hybrid, and traditional site-based models. For decentralized elements, the platform 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 Source 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.