Don’t let regulations, contracting, site readiness, and logistical complexities stall your study. Our proactive, globally aligned study start-up services minimize rework, accelerate first patient in (FPI), and streamline execution so you can move at the speed of science.
Kara Alberg brings significant expertise in global regulatory and study start-up operations and site activation. Beginning her career over 20 years ago as a subject recruitment specialist and clinical research associate, she has built deep, hands-on expertise to support all aspects of global study start-up. Her experience includes leadership roles across all regions within large and mid-sized CROs, where she has led global regulatory and study start-up teams to deliver measurable, high-quality results.
Executive Director and Head, Global Study Start-Up
Successful start-up requires coordinating feasibility, regulatory/ethics, site contracts, site readiness engagement, and logistics to connect workflows, share dependencies, and define a critical path for timely FPI.
Luckily, you don’t have to do it alone.
We focus on proactive coordination and risk management to:
Country-by-country variability can make start-up unpredictable, unless you partner with Caidya.
We drive early alignment, enabling smart parallelization, and applying deep local expertise across regulatory and operational landscapes.
Our structured workflows reduce contract and budget friction with standard templates, clear ownership, and parallel reviews, accelerating approvals and start-up timelines across every clinical development phase.
Specialized studies demand assessment of site-level operational realities against protocol needs — which is exactly what we do to ensure feasibility and reliable delivery.
We go beyond site activation to make sure your selected sites are truly prepared and committed to delivering on enrollment and supporting your study’s goals.
Kara Alberg - Executive Director and Head, Global Study Start-Up
We enable unbeatable activation readiness with end-to-end study start-up services including:
Rather than hoping start-up’s complex, interdependent processes don’t derail your timeline, let Caidya:
The biggest delays in study start-up typically stem from regulatory and ethics/IRB approvals, site contracting and budget negotiations, and the time required for sites to complete essential start-up documentation and readiness activities. These steps are highly interdependent and often vary significantly by country and institution, which can further compound timelines.
Variability in regulatory and ethics timelines across countries is managed through country-specific start-up intelligence, early engagement with local regulatory and legal experts, and parallel processing of activities wherever permissible. Strong governance, proactive tracking, and clear escalation pathways help keep submissions moving despite regional differences. Caidya’s extensive expertise executing cross-border trials around the world, and with particular insights in China, make us a distinct partner for sponsors.
Reducing contract and budget negotiation cycle times often requires early alignment on fair market value, use of standardized contract templates, and pre-approved legal and budget language. Engaging sites early with clear expectations and enabling parallel legal and budget review can significantly reduce iterative back-and-forth.
A site is considered truly “ready” when all critical activation components are complete and verified, including regulatory and ethics approval, executed contracts, trained personnel, investigational product availability, system access, and fully established operational workflows. Readiness is confirmed through structured activation checklists and, where applicable, simulation or dry-run activities.
When top-tier centers are oversubscribed, sponsors benefit from building a balanced site mix that includes high-performing academic centers alongside capable mid-tier and community sites with strong patient access. This approach reduces competition for limited enrollment capacity and improves overall recruitment resilience.
Protocol complexity directly impacts start-up timelines by increasing training requirements, expanding data capture needs, and adding operational and eligibility constraints at the site level. It may also necessitate additional vendor coordination and more extensive feasibility validation before activation.
Common start-up logistics dependencies include final regulatory and ethics approvals, executed contracts, investigational product release and shipment, system access setup, pharmacy preparation, and completion of site staff training. Delays in any of these areas can directly delay site activation or first patient in (FPI).
For specialized studies, such as those in cell and gene therapy, feasibility assessments go beyond questionnaires to include detailed operational interviews, workflow mapping, prior experience validation, pharmacy and chain-of-identity readiness checks, and on-site qualification visits when needed. These steps help sites have the infrastructure and capability to manage highly complex protocols safely and consistently.
During study start-up, it is important to track key leading indicators such as time to regulatory submission and approval, contract and budget cycle times, document turnaround performance, and readiness milestone completion. Real-time visibility into these metrics helps identify bottlenecks early and protect FPI timelines.
Patient burden should be carefully evaluated during start-up, including visit frequency, procedural intensity, travel requirements, time commitment, and the adequacy of reimbursement support. These factors significantly influence recruitment feasibility, retention risk, and overall study success.