Skip to content
Precision for Medicine
Contact Us
cf-ctdna

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.
  • Basket trials_Doctors discussing results
    Explore

    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.

     
    Explore
  • CTD_Hero
    Explore

    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.

     
    Explore
  • iStock-1177064020 (1)

    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.

     
PDF-pg34-(1)

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.

Clinical Data Management Medical Writing
Physicians reviewing patient data_case study
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.

Download this case study to learn more.

Download case study

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.

Explore our blog
Read: Why Global Oncology Evidence May Not Support U.S. Regulatory Approval Why Global Oncology Evidence May Not Support U.S. Regulatory Approval

Clinical Trials - Regulatory

Why Global Oncology Evidence May Not Support U.S. Regulatory Approval

|
    has not third author: true, (SizeLimitingPyMap: {main={hs_id=167363064857, hs_child_table_id=0, hs_updated_at=1719905898183, hs_published_at=1785476963368, description=Industry-leading oncologist and demonstrated medical leader in precision medicine, novel trial design and innovative regulatory initiatives designed to expedite drug approvals. Draws on nearly a decade leading oncology and rare disease programs at the FDA. Former fellow at the National Cancer Institute and frequent featured speaker at ASCO and AACR. CDER technical authority on oncologic drug and biological products for thoracic and head and neck malignancies, neurologic tumors, pediatric solid tumors and rare tumors., avatar=Image{width=553,height=580,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Harpreet-Singh2.png',altText='Harpreet-Singh2',fileId=171747124346}, linkedin=https://www.linkedin.com/in/harpreetsinghmd/, team=[{id=163072475007, name='Precision for Medicine Leadership'}], lastname=Singh, MD, hs_initial_published_at=1715692570942, hs_created_by_user_id=2737751, hs_created_at=1715692477118, hs_is_edited=false, hs_deleted_at=0, name=Harpreet, job=Chief Medical Officer, slug=harpreet-singh, hs_updated_by_user_id=65160865}, second={}, third={}})
  • Harpreet Singh, MD avatar

    Harpreet Singh, MD
Discover
Read: Early-Phase Oncology Trials in Ireland: Why START Dublin Is a High-Performing Site for Sponsors Early-Phase Oncology Trials in Ireland: Why START Dublin Is a High-Performing Site for Sponsors

Clinical Trials

Early-Phase Oncology Trials in Ireland: Why START Dublin Is a High-Performing Site for Sponsors

|
    has not third author: true, (SizeLimitingPyMap: {main={hs_id=164713188870, hs_child_table_id=0, hs_updated_at=1754641424769, hs_published_at=1785476963368, description=Deana Demjen is Director of the Precision Site Network, bringing nearly 20 years of clinical research to the role. Most of her previous experience has been in feasibility and site-identification. She has been covering a wide range of therapeutic areas, but her main focus are rare diseases where she is an acting subject matter expert. She is responsible for relationships with PSN sites as well as the maintenance and expansion of the network., avatar=Image{width=287,height=287,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/PfMxMarkentive/authors/Deana-Demjen-1.png',altText='Deana-Demjen-1',fileId=194123711869}, lastname=Demjen, hs_initial_published_at=1713363230550, hs_created_by_user_id=5166971, hs_created_at=1713363112834, hs_is_edited=false, hs_deleted_at=0, name=Deana, job=Director of PSN, slug=deana-demjen, hs_updated_by_user_id=65160865}, second={}, third={}})
  • Deana Demjen avatar

    Deana Demjen
Discover
Read: Why APAC Is Becoming a Design Decision Why APAC Is Becoming a Design Decision

Clinical Trials

Why APAC Is Becoming a Design Decision

|
    has third author: false, (SizeLimitingPyMap: {main={hs_id=199521241215, hs_child_table_id=0, hs_updated_at=1774887081250, hs_published_at=1785476963368, 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=65160865}, second={hs_id=199519203221, hs_child_table_id=0, hs_updated_at=1770145994248, hs_published_at=1785476963368, 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=65160865}, third={hs_id=199528025104, hs_child_table_id=0, hs_updated_at=1774885968488, hs_published_at=1785476963368, 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=65160865}})
  • James C. avatar Jing Ping Y. avatar Zhenfei Y. avatar

  • James C.

    Jing Ping Y.

    Zhenfei Y.
Discover

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.

  • Discover Explore
    clinical-trial-support

    Global CRO
    Services

    Award-winning CRO with deep oncology and rare disease expertise

    Explore
  • Discover Explore
    specialty-lab-services

    Global Laboratory
    Services

    Exceptional translational and biomarker sciences with global central lab services

    Explore
Loading...