Biomarker-driven Clinical Trials

At Precision, we are purpose-built around biomarker-driven clinical trials, and understand how to design these studies so that you can realize all that biomarkers promise-fast, efficient clinical development that maximizes your insight into patient biology.

Biomarker-driven Clinical Trials

At Precision, we are purpose-built around biomarker-driven clinical trials, and understand how to design these studies so that you can realize all that biomarkers promise-fast, efficient clinical development that maximizes your insight into patient biology.

Designing biomarker-driven clinical trials with precision

Successful delivery of biomarker-driven studies

Implement advanced trial designs

Getting the most insight and efficiency from biomarker-driven studies requires advanced clinical trial designs, which are quite complex and require sophisticated statistical expertise.

At Precision, we have the proven expertise to not only design but also successfully implement a range of advanced clinical trial approaches that are driven by biomarker data, including:

  • Basket trials
  • Umbrella trials
  • Adaptive trial designs
  • Master Protocols
Integrate advanced biomarker assays

Unlike other CROs, our biomarker expertise is in-house and biomarkers are completely integrated in all of our clinical trial processes. As a result, we can design biomarker-driven trials quickly, efficiently, and with a complete understanding of the technical nuances of virtually any biomarker assay.

Proactive planning to optimize the use of biomarkers in oncology clinical trials

Case Study: A “basket” trial and an accelerated pathway to proof of concept

Precision for Medicine had been working with a sponsor on a trial with an adaptive approach to exploring multiple tumor types concurrently as an accelerated pathway to proof-of-concept. However, the study had to overcome multiple challenges including a limited patient population (2% to 8% of all solid tumors), a biomarker approach that was not “standard of care” for all of the targeted cancers, and a complex patient screening process. In addition, the site study staff had to be able to handle highly technical genomic data.

Precision was able to design and implement a clinical trial for this study that has resulted in a total of 20 tumor-specific cohorts pursued and 7 treatment approaches eliminated. The trial continues to add cohorts and tumor-specific explorations, both as single and combination treatment approaches, and what started as 100 patients across 6 sites is now being conducted at ~50 sites globally with 250+ patients enrolled.

Find out how Precision overcame these studies challenges by reading the Case Study.

“Preselecting participants so that only those with certain molecular subtypes of cancer are included in a trial significantly improves the opportunity of achieving response rates in a greater number of patients, in a shorter time frame.”

Patricia Devitt Risse, PharmD
President, Clinical Solutions
Precision for Medicine

“Preselecting participants so that only those with certain molecular subtypes of cancer are included in a trial significantly improves the opportunity of achieving response rates in a greater number of patients, in a shorter time frame.”

Patricia Devitt Risse, PharmD
President, Clinical Solutions
Precision for Medicine

Tell us about your project requirements

Our expert team is ready to support your clinical design needs, ensuring maximum insight and efficiency from biomarkers. Start the conversation today.

Tell us about your project requirements

Our expert team is ready to support your clinical design needs, ensuring maximum insight and efficiency from biomarkers. Start the conversation today.

Clinical trial services

Global Clinical Trial Footprint

Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs.

Clinical Development Strategy

Tailored strategies consider the scientific, regulatory, and commercial factors that shape each trial, mitigating risk and advancing the development pathway.

Clinical Trial Design

Advanced trial-design approaches-including basket, umbrella, and adaptive trials-deliver biomarker driven clinical research. Deep experience in these highly complex trial designs maximizes both insights and efficiency.

Biostatistics

Seasoned biostatisticians and statistical programmers deliver insight into every trial phase, from study design to regulatory submissions, all backed by meticulous documentation and data monitoring.

Clinical Sample Management

Sample inventories from a global network of labs supply real-time processing in 55 countries; consolidated data from central labs, screening labs, and specialty labs with clinical data create actionable reports.

Explore other areas of expertise