Welcome to Yazar Lab!

Our firm offers industry-leading expertise in the design and execution of early through late stage clinical trials for psychedelic therapies. From protocol development and site selection to regulatory strategy and operational oversight, we partner with your teams to deliver rigorously designed studies that demonstrate safety, efficacy, and durability of effect. Our approach integrates validated outcome measures, patient-reported data, and innovative methodologies to ensure successful progression from trial design to regulatory submission.

We help translate clinical success into real-world practice through comprehensive pharmacoepidemiological research and Real World Evidence (RWE) generation. Our services cover study design, data source selection, cohort identification, and outcomes analysis—empowering clients to evaluate the effectiveness and safety of innovative therapies in diverse populations. The result is actionable evidence to support product adoption, health technology assessments, and regulatory or payer engagement.

Ensure your research and interventions are truly patient-centered with our support in patient engagement, inclusive research design, and culturally informed recruitment strategies. Our expertise in implementation science facilitates the successful integration of innovative therapies into real-world clinical settings, leading to improved participant adherence and sustained impact. We emphasize community engagement and feedback, laying the groundwork for both scientific rigor and meaningful patient experiences.

Successfully navigate the complex reimbursement landscape for novel therapies. We provide comprehensive support in developing value propositions, health economic analyses, and payer communication strategies. Our evidence-driven approach positions your therapies for optimal insurance coverage and access by articulating the clinical and economic benefits to payers and decision-makers.

Advance health equity in psychedelic science. We offer consulting on inclusive study design, culturally competent outcome measurement, community engagement strategies, and frameworks for identifying and addressing disparities. Our services ensure your programs are accessible, representative, and aligned with global best practices in diversity, equity, and inclusion.

Benefit from hands-on expertise in regulatory strategy and submission for psychedelic and other novel therapies. We guide you through regulatory requirements, dossier preparation, inspection readiness, and communications with agencies such as FDA, Health Canada, and EMA. Our experience with successful Breakthrough Designation, New Drug Application (NDA), and Health Technology Assessment (HTA) submissions and global launch planning helps accelerate your path from clinical trial to clinical practice.

We can provide expert support in Chemistry, Manufacturing, and Controls (CMC) for early stage biotech companies. We specialize in CMC regulatory strategy, dossier preparation, process and analytical development, GMP compliance, and risk management. Our services include the selection, qualification, and oversight of Contract Drug Manufacturing Organizations (CDMOs), ensuring the right partners and robust product quality. Partner with us for efficient, compliant, and accelerated product development.

We help life sciences organizations design and update Quality Management Systems in line with ICH GCP E6(R3) and EU Annex 11 & 22. Our services include gap analysis, SOP development, and system remediation to ensure compliant, secure, and effective adoption of artificial intelligence. Stay audit-ready and embrace innovation with confidence.

All packages can be further tailored for hybrid clients (such as academic spinouts or non-profit/industry partnerships) and for specific project needs. Engagement options include project-based, retainer, or milestone-linked consulting—ensuring responsiveness to your unique requirements.

Contact us today to schedule an introductory call or request a customized proposal for your organization.