Welcome to the Clinical Trials Consultation Club

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As a team of dedicated clinicians and scientists, we are committed to delivering exceptional services that combine operational excellence with full regulatory compliance. Our mission is to make it seamless for biotech, CRO, and pharmaceutical partners to engage with investigators and research sites that share their vision, energy, and scientific passion.

Our journey has strengthened our expertise, refined our processes, and deepened our commitment to advancing high-quality clinical research. We are proud of the impact we’ve made—and excited to continue supporting our partners with integrity, collaboration, and unwavering enthusiasm.

We welcome the opportunity to support your upcoming studies or collaborate on ongoing programs.
Whether you are a sponsor, CRO, or emerging biotech, we bring the expertise and flexibility needed to drive your development strategy forward.

Connect with us today to explore how we can support your program.

 Transform early scientific assets into a clear, regulator-aligned development strategy.
Clinical Consultation Club delivers an end-to-end Strategic Clinical and Regulatory Development Roadmap that supports regulatory engagement, investor readiness, and confident decision-making from preclinical development through marketing authorization.

Key capabilities include:

• Preclinical and translational gap assessment
• FDA, EMA, and regional regulatory pathway strategy
• High-level clinical development planning and endpoint strategy
• Integrated development timelines and budget forecasting
• Risk assessment and mitigation planning 
• Regional considerations, including Middle East readiness and Halal acceptance risk when applicable

Ideal for biotech, pharma, device, and combination product sponsors preparing for IND, CTA, Scientific Advice, or global expansion.

Delivery: milestone-driven engagement, typically completed in 10 to 12 weeks.

At Consultation Club, monitors are essential to clinical trials, and our mission goes beyond data review; they act as trainers and the primary contacts between sponsors and sites. Recognizing this crucial role helps our team feel proud and purposeful. We accomplish this by providing the following monitoring services: 

• Site qualification, initiation, monitoring, and closeout visits
   
• On-site, remote, and co-monitoring visits
   
• Source data verification and query resolution
   
• Protocol compliance and site training
   
• ISF/TMF QC and ongoing inspection readiness

• CRAs Monitoring Oversight Visits

• SOP development and process optimization
   
• RBQM frameworks, risk registers, and issue management plans
   
• CAPA development and implementation
   
• Mock inspections and health authority readiness

• Real-time safety signal detection and case evaluation
• Medical review of eligibility criteria, dosing decisions, and study endpoints
• AE/SAE assessment, MedDRA coding review, and narrative quality oversight
• Ongoing safety monitoring meetings with cross-functional teams
• Input into protocol design, amendments, and medical strategy
• Close collaboration with sites to ensure patient safety and data integrity

• Study planning, startup, and operational oversight
   
• Cross-functional team leadership and vendor management
   
• Timeline, budget, and risk management
   
• Enrollment strategy and site performance optimization
   
• Inspection readiness and regulatory compliance support

• Site training, tools, and resource development
• Patient retention strategies and materials
• Community outreach and engagement support
• Decentralized and hybrid trial readiness