Clinical Study Support

Pharmaceutical development in today's regulatory environment requires a cooperative, multi-dimensional approach. The experts at Metabolic Solutions can rapidly execute your isotopic tracer studies while providing customized, auditable solutions.

These flexible services can include:

Protocol Consultation: We review and make suggestions on all aspects of your protocol to ensure its successful implementation.

Site Training: Our experienced personnel instruct your clinical site staff on proper administration, collection and labeling of samples as well as any specific shipping and handling requirements.

Custom Dose Preparation: Carefully prepared doses are critical in stable isotope tracer studies. We prepare and document your study doses quickly and conveniently.

Custom Kit Building: Established GLP policies and procedures guarantee every item required for successful dose administration, sample collection and recording of information is provided to your clinical site.

Shipping Logistics: Prepaid shipping labels as well as instructions or supplies for packing and shipping are provided to protect the integrity of the samples.

Responsive Analytical Services: Sophisticated sample tracking and rapid turnaround are the hallmarks of our GLP mass spectrometry laboratory.

Calculations: Stable isotope tracer studies often lead to complex calculations of intricate metabolic functions and/or biochemical parameters. Our experienced staff guides you through these calculations to arrive at your desired study endpoints.

Data Transfer Options: Customized data expression and transfer are available.

Comprehensive Final Report: We include raw and calculated data, complete QA/QC reports, all study related SOPs, description of the calculations and any study deviations. The Study Director, the Director of Quality Assurance and all analysts review this final report prior to issuance.