Early Phase Research - Autoimmune
Case Study: Delivering an Early-Phase Autoimmune Trial Across Regions
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From first patient in to last patient out, Precision for Medicine delivers seamless clinical trial management that accelerates timelines and ensures quality. Our global team, advanced infrastructure, and proprietary technologies guide every step, helping you overcome complexity and achieve your development goals.
Our integrated regulatory, medical, clinical, and statistical expertise guides your program from IND through NDA submission—ensuring compliance, speed, and strategic clarity.
Streamline regulatory submissions, optimize site selection, and accelerate patient recruitment, ensuring faster start-up and smoother execution for your clinical trial.
Ensure expert execution with experienced project managers, clinical and medical monitors, and advanced RBQM technology for centralized monitoring. Our strong site relationships keep your trial on track and on time.
Deliver accurate, submission-ready data with expert biostatistics, streamlined data management, and comprehensive biometrics support, enabling faster database lock and ensuring regulatory compliance.
Integrating regulatory expertise, global development strategy, and operational excellence ensure seamless trial execution and expedited regulatory submissions. All of this is powered by a robust quality and technology platform that enables real-time risk mitigation and proactive quality management, giving you confidence at every stage.
Regulatory Expertise
Integrating regulatory, clinical, and medical expertise to guide your program from IND through NDA. Our strategies are led by ex-FDA experts, ensuring compliance and accelerating approvals.
Strategic Planning
Operational Excellence
Governance, Quality & Insight
Expert trial design and biomarker strategies to optimize early-phase studies. Navigate regulatory pathways and accelerate start-up for faster insights and smarter decisions.
Proven global capabilities to manage large-scale trials with precision. Our integrated approach ensures compliance, quality, and efficiency, driving success from pivotal studies to submission.
Industry-leading platforms like Veeva and proprietary solutions such as Cliniscope and Metavate enable data-driven trial execution and improve efficiencies at every stage of development. Our advanced technology ecosystem transforms complexity into actionable insights, empowering smarter decisions and faster progress.
Case Study - ONCOLOGY
Case Study - ONCOLOGY
This Phase 3 PSMA-targeted imaging trial in prostate cancer, ran across the U.S. and Canada, required on-time administration of a short-lived radiopharmaceutical within hours of delivery. Read how this study scaled while maintaining dose-on-time compliance, zero site shutdowns, and robust imaging data quality.
Precision for Medicine’s recognition in the 2024 CRO Leadership Awards across every category reflects more than excellence—it underscores our commitment to advancing your clinical trials. Our award-winning expertise delivers not only superior trial management but also a shared mission to bring transformative therapies to patients worldwide.
See how consistent industry recognition demonstrates our dedication to quality, innovation, and success in clinical trial management.
Our partnership with Precision is a true textbook definition of a great collaboration between a sponsor and a CRO.
I recognize that relations between Sponsors and CRO vendors can be strained and difficult, often a blaming game; this has never been my experience with this group as it truly felt like a partnership.
We have been delighted with the experience level and work product from the entire project team – they feel like an extension of our internal team.
At so many levels, the Precision for Medicine team has been fantastic. I am very grateful for how responsive and how collaborative the whole team is. Very grateful for their help.
We understand that every development pathway begins and ends with a patient. Supporting our partners in delivering innovative treatments is our purpose. Leverage our proven expertise across complex therapeutic areas and advanced modalities to bring transformative therapies to those who need them most.
How many countries can Precision for Medicine support simultaneously?
Precision delivers truly global trial management, supporting studies across North America, Europe, Asia-Pacific, and Latin America through an integrated network of local experts and regulatory specialists.
We routinely manage multi-country, multi-regional oncology and rare-disease trials, ensuring harmonized trial conduct, consistent data quality, and rapid study start-up across all participating regions.
What is the typical timeline for first-patient-in in multi-region trials?
Timelines vary by indication and geography, but Precision focuses on accelerating feasibility, regulatory submissions, and site activation to expedite FPI timelines.
Our global start-up model—supported by predictive feasibility, country-specific regulatory intelligence, and centralized project governance, typically enables FPI within 3–6 months in priority markets.
How do you manage global regulatory submissions and country-specific compliance?
Our regulatory operations team manages end-to-end global submissions, from IND/CTA strategy and dossier preparation to ongoing Health Authority engagement across each region.
We combine local regulatory expertise, global SOPs, and centralized quality oversight to ensure every country meets its specific requirements, reducing delays, preventing rework, and ensuring inspection-readiness throughout the trial.
How do you manage patient recruitment and retention across regions?
Precision uses data-driven enrollment forecasting, site-level analytics, and real-time centralized monitoring to identify risks early and optimize recruitment strategies.
Our teams work closely with investigators to implement country-specific outreach plans, streamline pre-screening, and support protocol adherence — all of which strengthen retention, diversity, and time-to-enrollment.
What is your monitoring model for global trials (remote vs on-site)?
Every trial is different and we tailor the monitoring strategy to align with the needs of each program. Precision also offers a hybrid monitoring model that is built on:
Can you support decentralised or hybrid trials across multiple regions?
Yes. We design and manage decentralized and hybrid trial models across multiple regions, leveraging remote assessments, digital tools, home-health services, and flexible visit schedules.
Our operational framework ensures regional regulatory compliance, data integration, and consistent patient experience, making complex global DCTs feasible, scalable, and audit-ready.
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Early Phase Research - Autoimmune
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Rui F Duarte-Lopes
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Leverage an integrated infrastructure that reduces the inefficiencies inherent in complex development. Integrate lab and trial execution to accelerate speed to market. Precision can customize and converge our capabilities to meet your program's unique needs—driving efficiency, agility, and success from start to finish.
A recognized leader in oncology and rare diseases with rich experience in complex trials
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Experts in translational and biomarker sciences with worldwide specialty labs and central lab services that are enabling breakthroughs.