How do we minimise operational risks and prevent delays?
A well-designed protocol alone does not guarantee success — operational management must also be strong.
At Biostat®, our model focuses not only on documentation quality, but above all on risk management and maintaining the study timeline.
From experience, we know that delays usually stem from small organisational issues, poor communication or resource miscalculations.
To avoid these, we implement proven practices from the planning stage onward.
Our proven risk-management practices
1. Building a realistic study timeline
We analyse every stage — documentation, ethics/regulatory approvals, recruitment, monitoring and reporting — and create a timeline with built-in safety margins to prevent cascading delays.
2. Thorough feasibility analysis
Before study initiation, we assess site potential, recruitment capabilities, competing projects and demographic/epidemiological factors.
This allows us to predict recruitment pace accurately and select sites that can realistically meet study expectations.
3. Optimising the protocol
Small adjustments — simplifying inclusion criteria, merging procedures, reducing visits — can significantly accelerate recruitment and reduce costs.
Our methodologists and biostatisticians advise on balancing scientific value with operational feasibility.
4. Dedicated Project Manager
Every Biostat® project has a dedicated PM who coordinates all operational aspects and serves as a single point of contact for the sponsor and sites.
5. Transparent progress reporting
Sponsors receive regular reports, dashboards and KPI updates (recruitment rate, visit status, site performance, financials).
This transparency facilitates quick decision-making.
6. Real-time risk monitoring
Using RBM (Risk-Based Monitoring) and the Risk Management Plan, we quickly detect deviations before they affect the timeline.
Quality metrics such as query rate or completeness rate help identify issues early.
7. Ongoing communication with sites
We maintain close contact via calls, online meetings, newsletters and system reminders.
Efficient communication solves issues early and keeps sites engaged and coordinated.
8. Built-in flexibility and buffers
We plan timeline buffers for regulatory decisions, contracts and logistics.
This ensures resilience against unexpected delays.
The outcome? Stability and peace of mind
With strong project management and continuous risk oversight, Biostat® maintains timeline stability and detects deviations early.
Sponsors gain:
• predictable study duration,
• fewer unplanned delays,
• reduced corrective costs,
• and smooth project delivery.
Well-planned studies succeed not just because of documentation — but because of people and risk management. This is where Biostat® stands out.
