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.

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

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.

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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.

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John M.
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has not third author: true, (SizeLimitingPyMap: {main={hs_id=167906611101, hs_child_table_id=0, hs_updated_at=1762899997332, hs_published_at=1767769678459, description=Helen brings over 30 years of experience in multinational healthcare, biotech, and pharmaceutical industries, including work with Medical Research Institutes and CROs. She specializes in leading clinical research, drug and device development, and fostering innovative research collaborations. Based in Sydney, Australia, Helen has a strong track record of delivering clinical trials across the APAC region., avatar=Image{width=600,height=700,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Helene-Ormandy.png',altText='Helene-Ormandy',fileId=168387434767}, lastname=Ormandy, PhD, hs_initial_published_at=1716212950394, hs_created_by_user_id=2737751, hs_created_at=1716212897654, hs_is_edited=false, hs_deleted_at=0, name=Helen, job=Executive Director, Clinical Operations, slug=helen-ormandy, hs_updated_by_user_id=65160865}, second={hs_id=197935898186, hs_child_table_id=0, hs_updated_at=1761062728726, hs_published_at=1767769678459, description=Hardik Badani is a seasoned clinical research professional with a proven track record in managing complex, multi-regional clinical trials across North America, Europe, Asia-Pacific, and Africa. Based in Singapore, Hardik brings over a decade of experience in clinical operations, portfolio oversight, and project finance. He is a certified Project Management Professional (PMP) and was recognized with the Bronze award at the 2020 PharmaTimes International Clinical Researcher of the Year competition. Hardik’s expertise spans the full spectrum of clinical trial delivery—from startup through closeout—with a strong command of clinical systems including CTMS and EDC platforms. His leadership style emphasizes collaboration, operational excellence, and a deep commitment to advancing global health through precision-driven research., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Hardik%20Badani.png',altText='Hardik Badani',fileId=197937156662}, lastname=Badani, hs_initial_published_at=1761062733198, hs_created_by_user_id=26433386, hs_created_at=1761062663685, hs_is_edited=false, hs_deleted_at=0, name=Hardik, job=Principal Clinical Trial Manager, slug=hardik-badani, hs_updated_by_user_id=65160865}, third={}})

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Specialized capabilities in every stage of clinical development

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