# LIFE SCIENCES /// CLINICAL DEVELOPMENT

Boost confidence at each developmental milestone

Inform trial strategy and design, execute efficient trials, and drive IUO/CDx strategies.

- **8.5M+** de-identified research records
- **~5K** connected healthcare institutions
- **~1K** tumor-derived organoids across a range of indications
- **5M+** cancer patients covered by the TIME network
- **~100** sites representing 800+ clinical locations participate in TIME network

### Explore our clinical development applications

Clinical Development

- [**Clinical Trial Design**](https://www.tempus.com/life-sciences/clinical-development/#clinical-trial-design)
- [**Biomarker Strategy**](https://www.tempus.com/life-sciences/clinical-development/#biomarker-strategy)
- [**Clinical Trial Execution**](https://www.tempus.com/life-sciences/clinical-development/#clinical-trial-execution)
- [**Indication Selection**](https://www.tempus.com/life-sciences/clinical-development/#indication-selection)
- [**IUO Validation & CDx Development**](https://www.tempus.com/life-sciences/clinical-development/#iuo-validation-cdx-development)

#### Clinical Trial Design

Address tumor heterogeneity and identify optimal responder patient populations to design clinical trials that enable the evaluation of safety and efficacy while also monitoring resistance mechanisms.

- Uncover [**real-world insights**](https://www.tempus.com/life-sciences/data-collaborations/) regarding patient demographics, treatment regimens, and outcomes to define I/E criteria and preliminary endpoints, as well as guide the selection of appropriate comparator therapies and inform decisions on trial design, dosing, and safety monitoring.

[**Strategically simulate and contextualize data** 
Mirati leverages Tempus RWD to revise its KRAS strategy and refine patient selection.](https://www.tempus.com/resources/content/case-studies/make-quicker-decisions-by-simulating-and-contextualizing-data-with-tempus/)

#### Biomarker Strategy

Optimize patient selection, monitor drug effects, assess safety, and predict treatment outcomes between trial phases to guide clinical decisions and support regulatory submissions.

- Enhance patient stratification through insights surfaced across [**multimodal datasets**](https://www.tempus.com/life-sciences/data-collaborations/), further validating biomarkers by correlating them with real world clinical outcomes in various patient subgroups.
- Monitor treatment effects in real-time through a [**multi-omic approach**](https://www.tempus.com/life-sciences/omics-solutions/) to anticipate mechanisms of resistance.

[**Reduce time to launch with multimodal data** 
How AstraZeneca simplified its approach to TROPION-Lung01 and drove down time to launch.](https://www.tempus.com/resources/content/case-studies/reduce-time-to-launch-with-tempus-and-multimodal-data/)

#### Clinical Trial Execution

Identify and enroll diverse patient populations, activate trial sites quickly, and maintain high-quality data collection protocols.

- Leverage real-world data to optimize study design and a [**vast provider network**](https://www.tempus.com/life-sciences/clinical-trial-solutions/) to select sites, accelerate activation, and algorithmically match potentially eligible patients for enrollment.
- Engage a strategic [**Contract Research Organization**](https://www.tempus.com/life-sciences/compass) to manage trial operations from start to finish, including feasibility and planning, patient recruitment, and data collection across multiple sites.

[**Activate trial sites faster** 
Sermonix was able to accelerate timelines for first patient in and enrollment by working with Tempus.](https://www.tempus.com/resources/content/case-studies/activate-trials-faster-with-the-time-program/)

#### Indication Selection

Prioritize disease states based on therapeutic potential to address unmet patient needs and potential for regulatory and commercial success.

- Assess disease prevalence, patient demographics, treatment gaps, and current therapeutic outcomes across [**multimodal RWD cohorts**](https://www.tempus.com/life-sciences/data-collaborations/) to identify areas of high unmet need and evaluate clinical feasibility.
- Simulate disease mechanisms and drug interactions in [**tumor organoid models**](https://www.tempus.com/life-sciences/biological-modeling/) to evaluate treatment safety and efficacy of various indications.

[**PAVO: Assessing the safety and efficacy of niraparib (PARPi)** 
Accelerating clinical trial start-up and execution with an end-to-end approach.](https://www.tempus.com/publications/pavo-a-phase-ii-open-label-single-arm-study-of-niraparib-in-patients-with-locally-advanced-metastatic-palb2-mutated-tumors/)

#### IUO Validation & CDx Development

Leverage a broadly distributed platform and a data-driven approach for IUO assay and companion diagnostic development.

- Analyze **[real-world evidence](https://www.tempus.com/life-sciences/data-collaborations/)** to understand biomarker prevalence and assess its predictive value in real-world settings to guide more effective patient selection for targeted therapies.
- Detect mutations, resistance mechanisms, and tumor heterogeneity to optimize for clinical utility through [**comprehensive genomic profiling**](https://www.tempus.com/life-sciences/omics-solutions/).

[**Enhance clinical development with Tempus’ CDx platform** 
A2 Biotherapeutics uses HLA-LOH as a biomarker to progress breakthrough cell therapy.](https://www.tempus.com/resources/content/case-studies/enhance-your-clinical-development-process-with-tempus-cdx-platform/)

### Trusted by hundreds of biopharma to power drug development