Scaling With Scientific Control

It’s not just about capacity. Selecting a strong CRO partner for your molecule’s late-phase bioanalysis means prioritizing: 

• Direct access to senior scientists

• Industry-leading, fit-for-purpose methods

• Embedded automation

• The best-available instruments for the job

• Regulatory-ready, defensible data

• A team you never have to wait on

You may know Aliri as bioanalytical problem-solvers; a team whose continuous innovation in LC-MS bioanalysis and spatial biology stays one step ahead of emerging modalities, so you never have to question how you will prove the safety and efficacy of your molecule.  

What you may not know is that we’ve been driving both small and large molecule clinical trials for over 30 years, enabling fast turnaround times while safeguarding data quality by scaling programs with scientific control. This support is made possible by our Clinical APEX Process, a rigorously implemented workflow consistent across all global laboratories, that ensures regulatory-ready data delivery on time, every time.  

The Clinical APEX Process:

1. Comprehensive Project Alignment: A successful study starts with full alignment between our team and yours. We meet early to discuss project expectations, create a custom communication plan that meets your needs, and collaborate on a timeline that ensures accountability and peace of mind for on-time delivery. Unlike other large CROs, we don’t play favorites, meaning that no matter the size of your project, you’ll have direct access to senior scientists throughout the duration of your study.  In addition, all members of your full project team participate in twice-a-day huddles and execute each phase in lockstep.  This streamlines communication, allows for quick problem-solving, and ensures you are never waiting for an answer.
2. Integrated Method Development and Validation: We know every day is critical when it comes to clinical sample analysis, which is why we integrated Method Development with Method Validation, with both teams working collaboratively to save time and ensure cost efficiency. Pre-clinical methods are always developed with clinical readiness in mind, ensuring smooth transfers and saving up to two weeks when it matters most. For spatial tissue biomarker studies, assay development and fit-for-purpose validation are performed using representative study matrices and tissues, ensuring analytical performance is demonstrated within the intended context of use.
3. Automation-Accelerated Sample Analysis: Successful high-volume clinical sample analysis isn’t just about having capacity. Our scientists condense timelines by harnessing our extensive fleet of industry-leading instruments and automations like multiple plate batch sizes, automated bulk preps, automated tissue slide prep, and automated immunohisto-staining. This process reduces human error and saves hours of run time, all while maintaining rigorous adherence to regulatory requirements.
4. Run-by-Run Quality Control & Process-Based Quality Assurance: Data quality is something we will never compromise on. Data is submitted to our quality control team on a run-by-run basis, ensuring quality and consistency throughout the project, rather than at study-end. When pivots are necessary, our scientific team provides prompt, transparent communication along with clear solutions. Approved changes are implemented immediately to keep your program on track. Process-based quality assurance allows your study to benefit from optimizations made as a result of previous studies, reliably ensuring audit-ready processes in line with clinical expectations.
5. Regulatory-Ready Data Delivery:  With over 800 late-phase studies and 30 years of regulatory audits with a 100% pass rate, we have proudly supported dozens of drugs through commercialization. We are committed to delivering highly accurate, decision-ready data, on time, every time.