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Clinical Trial Design that Maximizes Biomarker-Driven Insights

Intuitive, biomarker-driven clinical trials, designed with Precision
Patient populations can be refined, rather than randomized, based on umbrella or basket designs, depending on the nature of the study drug and relevant indications as well as the different types of clinical research being performed. Our team of Precision experts focuses on protocol nuances to match each patient with the optimal study population and gain valuable insights from biomarkers. This results in a “rapid-to-market” strategy precisely tailored to your product.
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    Basket & Umbrella Trials

    We carefully select sites for both their scientific expertise and patient recruitment success, then maintain constant communication for nimble decision-making that accelerates proof-of-concept for various types of clinical studies.

     
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    Biomarker Clinical Trials

    We use diagnostic, prognostic and predictive biomarkers to enable informed decision making, resulting in a faster approval time and a statistically higher rate of commercialization.

     
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    Master Protocol Trials

    We stay at the forefront of clinical trial design, pairing statistical rigor and biomarker expertise to design and implement master protocol trials.

     
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Informed by biomarkers.
Designed for insights.

Biomarker-driven science seamlessly integrated with clinical development.

A precision-driven approach ensures that robust molecular-level data positions the right patient with the right drug. With our expertise in translational medicine and clinical trial execution, every trial design is informed by advanced biomarkers and is purpose-built for improved insights and streamlined trial execution.

Integrated solutions can optimize your study’s strategy and trial design. Harnessing the efficiency of biomarker-driven studies not only accelerates the trial process but also ensures that Precision delivers clinical developments faster and with greater insight compared to conventional trial designs.

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Case Study

A basket trial and an accelerated pathway to proof-of-concept

As part of a long-term collaboration, Precision for Medicine used an adaptive approach to explore multiple tumor types concurrently, accelerating the pathway to proof-of-concept. 

Targeted patient:

The study targets subjects with a specific rare mutation. The protocol identifies a list of possible mutations. All patients are required to have genomic assays completed with the mutation identified before enrollment will be considered.

Study design:

The initial protocol had 8 different tumor-specific mutation cohorts in a Simon’s 2-stage design. For the first stage, 7 patients are enrolled; if 1 response is observed the cohort expands to stage 2. If no responses are identified, the cohort may be closed, with new tumor types identified. Tumor types are ruled “in” for further exploration (up to the point of accelerated approval or phase 3 investment) or “out” within this trial.

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Insights from Precision’s experts

Stay ahead with the latest insights from Precision’s team of experts. Discover valuable perspectives, updates, and strategies to design optimal global clinical programs.

Read: Why APAC Is Becoming a Design Decision Why APAC Is Becoming a Design Decision

Clinical Trials

Why APAC Is Becoming a Design Decision

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    has third author: false, (SizeLimitingPyMap: {main={hs_id=199521241215, hs_child_table_id=0, hs_updated_at=1774887081250, hs_published_at=1784230314171, description=An industry veteran with nearly three decades of experience in the clinical research industry and deep expertise in clinical operations and strategic leadership across both pharmaceutical and CRO environments. Held pivotal roles as Head of Clinical Operations for Greater China at Boehringer Ingelheim, leading trials in oncology, respiratory, stroke, and cardio-metabolic diseases and CEO of George Clinical, a global CRO with strong scientific capabilities in renal and oncology therapeutic areas. At Precision for Medicine, a leader for business strategy across the Asia Pacific region. Focused on driving regional growth, building strategic partnerships, and supporting excellence in portfolio delivery and client satisfaction. An acknowledged driver of precision-driven solutions that improve patient outcomes., avatar=Image{width=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/James%20Cheong.png',altText='James Cheong',fileId=199519079710}, linkedin=https://www.linkedin.com/in/james-cheong-36a543a/, lastname=Cheong, hs_initial_published_at=1762885727645, hs_created_by_user_id=78347666, hs_created_at=1762885637470, hs_is_edited=false, hs_deleted_at=0, name=James, job=Senior Vice President, Asia Pacific, Clinical Solutions​, slug=james-cheong, hs_updated_by_user_id=51739740}, second={hs_id=199519203221, hs_child_table_id=0, hs_updated_at=1770145994248, hs_published_at=1784230314171, description=Highly accomplished global clinical operations executive with nearly three decades of experience providing strategic leadership, regional expansion, and operational excellence across Asia Pacific. Brings deep expertise across clinical development, project and portfolio operations, biometrics, regulatory affairs, safety and pharmacovigilance, quality management, and financial governance. Proven builder and scaler of high‑performing teams and start‑up operations in both regional and global environments. Recognized industry leader who actively contributes to advancing clinical research standards through advisory and governance roles across Asia., avatar=Image{width=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Jing%20Ping%20Yeo.png',altText='Jing Ping Yeo',fileId=199530854290}, linkedin=https://www.linkedin.com/in/jing-ping-yeo/, lastname=Yeo, PhD , hs_initial_published_at=1762893310168, hs_created_by_user_id=78347666, hs_created_at=1762893091367, hs_is_edited=false, hs_deleted_at=0, name=Jing Ping, job=Vice President, Clinical Operations, Head of Asia Pacific​, slug=JingPing-Yeo, hs_updated_by_user_id=51739740}, third={hs_id=199528025104, hs_child_table_id=0, hs_updated_at=1774885968488, hs_published_at=1784230314171, description=With 20+ years of experience in the clinical trial industry, he has led project management, clinical operations, and business development teams. Prior to joining Precision, he served as the General Manager of Emerald (formerly George Clinical) China, and held project management and business development leadership roles at ICON, WuXi CDS, IQVIA, and KUNTUO. He has successfully led teams to complete more than 120 Phase I–IV clinical trials, many of which were MRCT studies across Asia‑Pacific, Australia, and the United States. He holds a Master’s degree in Urology from Peking University First Hospital., avatar=Image{width=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Zhenfei%20Yin.png',altText='Zhenfei Yin',fileId=199530854553}, lastname=Yin, hs_initial_published_at=1762893310168, hs_created_by_user_id=78347666, hs_created_at=1762893190542, hs_is_edited=false, hs_deleted_at=0, name=Zhenfei, job=China Country Head, Senior Director, Project Management​, slug=Zhenfei Yin, hs_updated_by_user_id=51739740}})
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Read: Case Study: Delivering an Early-Phase Autoimmune Trial Across Regions Case Study: Delivering an Early-Phase Autoimmune Trial Across Regions

Clinical Trials - Early Phase Research - Autoimmune

Case Study: Delivering an Early-Phase Autoimmune Trial Across Regions

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    has third author: false, (SizeLimitingPyMap: {main={hs_id=214928090133, hs_child_table_id=0, hs_updated_at=1781285625399, hs_published_at=1784230314171, description=Deborah Spencer is a Senior Director of Project Management at Precision for Medicine with over 25 years of experience in clinical research. She specialises in leading global clinical trials across multiple phases, with deep expertise in complex study delivery. Deborah provides strategic oversight of programmes, leads high-performing teams, and partners closely with sponsors to ensure successful execution and regulatory readiness., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Deborah%20Spencer.jpg',altText='Deborah Spencer',fileId=214838919278}, lastname=Spencer, hs_initial_published_at=1781285742914, hs_created_by_user_id=26433386, hs_created_at=1781285562019, hs_is_edited=false, hs_deleted_at=0, name=Deborah, job=Senior Director, Project Management, slug=deborah-spencer, hs_updated_by_user_id=51739740}, second={hs_id=214928170660, hs_child_table_id=0, hs_updated_at=1781285676367, hs_published_at=1784230314171, description=Anthea Gates is a Project Director with approximately 30 years of drug development and medical device industry expertise across all phases, over a variety of indications including breast, lung cancer, solid tumors and lymphoma, cutaneous T-cell lymphoma, malignant melanoma, squamous cell carcinoma, rare haematologic disease, autoimmune rheumatology, osteoarthritis, ocular burns, liver cirrhosis, myopia and pre-eclampsia. Committed to delivering quality and passionate about building positive relationships with clients and study teams to promote cohesive business practices and ensure the successful management of projects from start to finish. Anthea holds a proven track record in effective leadership of cross-functional teams across programs of studies, to the accomplishment of operational excellence., avatar=Image{width=372,height=546,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/profile.jpg',altText='profile',fileId=214846873938}, lastname=Gates, hs_initial_published_at=1781285742914, hs_created_by_user_id=26433386, hs_created_at=1781285639221, hs_is_edited=false, hs_deleted_at=0, name=Anthea, job=Project Director, slug=anthea-gates, hs_updated_by_user_id=51739740}, third={hs_id=214928090141, hs_child_table_id=0, hs_updated_at=1781285738567, hs_published_at=1784230314171, description=Claire Delaville is a Senior Project Manager at Precision for Medicine. She brings 18 years of experience across preclinical and clinical research, including more than a decade leading Phase I to IV studies in oncology, rare diseases, and immunology, with direct experience in first-in-human and multicenter oncology trials. Claire is responsible for maintaining study quality through inspection readiness, corrective action planning, and proactive risk mitigation. She also oversees study budgets and vendor performance to support coordinated delivery across functions, drawing on a scientific foundation that includes a PhD in Neurosciences and Neuropharmacology. Based in Paris, France, Claire aligns scientific insight with operational execution to support successful trial outcomes., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Claire%20Delaville.jpg',altText='Claire Delaville',fileId=214838927033}, lastname=Delaville, hs_initial_published_at=1781285742914, hs_created_by_user_id=26433386, hs_created_at=1781285678112, hs_is_edited=false, hs_deleted_at=0, name=Claire, job=Senior Project Manager, slug=claire-delaville, hs_updated_by_user_id=51739740}})
  • Deborah S. avatar Anthea G. avatar Claire D. avatar
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Read: Early‑Phase Autoimmune Drug Development: Trial Design, Biomarkers and Statistical Strategies Early‑Phase Autoimmune Drug Development: Trial Design, Biomarkers and Statistical Strategies

Clinical Trials

Early‑Phase Autoimmune Drug Development: Trial Design, Biomarkers and Statistical Strategies

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=213698206365, hs_child_table_id=0, hs_updated_at=1780680681226, hs_published_at=1784230314171, description=Rui F. Duarte‑Lopes is a senior biostatistics leader with over 31 years of international experience across biopharmaceutical, biotechnology, and CRO sectors. He provides strategic statistical oversight, ensuring rigorous, high‑quality, and decision‑focused delivery aligned with sponsor and regulatory expectations. He has more than 12 years of CRO experience supporting Phase I–IV clinical trials and has held roles including Lead Statistician, Project Lead, and Senior Manager. His therapeutic experience includes oncology and autoimmune diseases, notably lupus erythematosus, Crohn's disease and rheumatoid arthritis. Specializing in oncology over the past six years, Rui focuses on advanced solid tumors and early‑phase studies, contributing to study design, interim analyses, and data‑driven decision frameworks., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Rui%20F%20Duarte-Lopes.jpg',altText='Rui F Duarte-Lopes',fileId=213695319705}, lastname=Duarte-Lopes, hs_initial_published_at=1779886328878, hs_created_by_user_id=26433386, hs_created_at=1779886165792, hs_is_edited=false, hs_deleted_at=0, name=Rui F, job=Senior Manager, Biostatistics, slug=rui-f-duarte-lopes, hs_updated_by_user_id=51739740}, second={}, third={}})
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    Rui F Duarte-Lopes

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Specialized capabilities in every stage of clinical development

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.

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