Our Methodology

To maximize patient recruitment time and support the achievement of milestones, SA initiates start-up activities for up the selected sites. This well-researched strategy based on global best practices leverages decades of industry data, significantly mitigating high site attrition rates and activation delays, thereby increasing the probability of meeting or exceeding milestones.

In our commitment to ensuring your success, SA proactively funds the start-up costs with the sponsors for these additional sites, activating them in parallel with the initially selected ones. This approach guarantees a smooth transition in the face of delays, low enrollment, or post-activation withdrawals, thereby maintaining the integrity of study timelines.

Parallel Site Preparation

Scientific Amici initiates start up activities for multiple qualified research sites at the same time to support continuity during early study phases. Preparing sites in parallel reduces reliance on a single activation pathway and strengthens overall study readiness across diverse clinical and geographic settings.

By advancing readiness across more than one site group, studies are better positioned to sustain progress when individual sites experience delays related to contracting, regulatory review, or local operational constraints. This approach supports steady execution while maintaining alignment with protocol requirements and patient protections.

Data Informed Site Readiness

Site readiness is guided by structured assessments that incorporate historical performance data, feasibility inputs, and operational indicators. This evidence based approach supports the identification of sites with the capacity and infrastructure required to engage patients effectively and meet study requirements.

Grounding readiness decisions in data supports consistency across sites and helps align preparation activities with patient centered enrollment objectives. This process ensures that resources are applied thoughtfully and in proportion to real world site capabilities and study needs.

Centralized Start Up Coordination

Scientific Amici coordinates contracts, budgets, and start up documentation through a centralized framework that promotes clarity, consistency, and transparency across participating sites. This approach reduces administrative fragmentation and supports timely review and approval across sponsors, CROs, and research sites while maintaining alignment on roles, responsibilities, and expectations. Centralized coordination also supports clearer communication during early study phases, allowing operational issues to be identified and addressed efficiently without disrupting site engagement or study momentum.

Technology Enabled Monitoring

Technology supported tools are used to monitor site readiness and early operational signals during the start up period. These tools provide visibility into preparation status and support informed assessment of site progress as studies move toward activation.

Operational insights generated through monitoring are used to support timely adjustments and ongoing oversight while maintaining adherence to study protocols and regulatory requirements. Monitoring activities are applied in a manner that complements site operations and supports responsible decision making.

Regulatory and Ethical Alignment

All start up and activation activities are conducted in accordance with applicable regulatory requirements and ethical standards. Scientific Amici prioritizes patient protections, data integrity, and responsible research conduct throughout all stages of site preparation and activation. This commitment supports consistent application of regulatory expectations across participating sites and geographies while reinforcing trust among patients, investigators, sponsors, and oversight bodies.