Build Your Study on a Foundation That’s Sound and Operationally Proven
Protocol Design
Expert protocols—delivered at your speed, designed to de-risk your study from the start
Before your study begins, our scientists work with you to define every key variable.
You’ll have a detailed, study-ready protocol that sets the foundation for confident execution, covering your study’s technical, operational, and regulatory plan.
What you get
- Needs assessment and protocol planning
- Analytical methods selection or validation
- GLP or non-GLP alignment
- Site training requirements
- Kit specifications (tracer, time points, instrumentation)
- Data output expectations
- Reporting, documentation, and archiving setup
Training & Site Support
Site training that prevents protocol drift and execution errors
Once your protocol is finalized, we don’t leave execution to chance. We train your teams—internal and external—to run the study exactly as designed, minimizing variability and ensuring site-level compliance.
Our scientists provide tailored education for your study staff, CROs, and site personnel, so every variable is handled correctly from the start.
What you get
- Internal GLP and protocol-specific staff training at Metabolic Solutions.
- CRO and site training for sample collection, handling, and timing.
- Education on unique specimen types (e.g., breath, saliva, cryovials).
- Instructions for proper storage and dose separation.
- Documentation and compliance protocols for multi-site studies.
- Optional creation of a custom Site Manual for standardized execution.
- On-call support for clarification during startup.
Deliver Kits and Data That Keep Your Study on Protocol and On Schedule
Custom Kit Building
Expert protocols—delivered at your speed, designed to de-risk your study from the start
Before your study begins, our scientists work with you to define every key variable.
You’ll have a detailed, study-ready protocol that sets the foundation for confident execution, covering your study’s technical, operational, and regulatory plan.
What you get
- Dose formulation and isotope identification.
- Labeling, documentation, and regulatory specifications (GLP vs. non-GLP).
- Time point planning and collection container prep.
- Return logistics (e.g., shipping materials, pre-addressed labels).
- QA-reviewed SOP-driven assembly with lot numbers and expiration tracking.
- Optional inventory storage in temperature-controlled, secure facilities.
- Direct-to-site or on-demand shipping based on study timeline.
Stable Isotope Identification
Validated stable isotope assays, built for reproducibility and regulatory trust
Whether you need a standard assay or a custom-developed method, Metabolic Solutions delivers high-precision analysis with full GLP compliance. Every sample is tracked, verified, and designed for stable isotope tracer studies.
From the moment your specimens arrive to the delivery of raw data, our workflows protect sample integrity, analytical accuracy, and regulatory alignment.
What you get
- Assay selection from our validated test library.
- Method development and validation for novel protocols.
- Sample intake verification with unique identifiers.
- GLP-compliant stable isotope analysis by trained staff.
- Real-time resolution of sample issues by Study Director.
- QA-controlled instrument calibration and data integrity checks.
- Optional secure sample and data storage with.
- 24/7 temperature monitoring.
- Daily backups and generator protection.
- Chain-of-custody documentation.
Final Reports That Withstand Scrutiny and Accelerate Regulatory Decisions
Flux Calculations & Data Analysis
From complex data to clear, validated endpoints
Data is only as useful as your ability to interpret it. We simplify complex enrichment data into validated, study-ready outputs—using regulatory-compliant models and customized calculation tools that align with your protocol goals.
Whether you're modeling breath curves or translating enrichment ratios into physiological meaning, our team ensures your data tells the right story, clearly.
What you get
- Pre-built, study-specific spreadsheet models (e.g. gastric emptying curves).
- CFR Part 11–validated calculation tools.
- Simplified, interpretable data outputs aligned to protocol endpoints.
- Support for custom calculations beyond standard units.
- Ongoing scientist-to-scientist dialogue for interpretation.
- Real-time data clarification during or after analysis delivery.
Customized Reporting
Validated stable isotope assays, built for reproducibility and regulatory trust
Whether you need a standard assay or a custom-developed method, Metabolic Solutions delivers high-precision analysis with full GLP compliance. Every sample is tracked, verified, and processed in a purpose-built lab designed for stable isotope work.
From the moment your specimens arrive to the delivery of raw data, our workflows protect sample integrity, analytical accuracy, and regulatory alignment.
What you get
- Final Bioanalytical Report formatted for clinical submission.
- Study director, QA, and analyst signoffs.
- Executive summary with study context.
- Description of stable isotope analysis methods performed.
- Detailed results and interpretation structure.
- SOPs referenced and deviations documented.
- Quality control and traceability data.
- Formatting aligned for database upload or integration.
- Secure data delivery via web portal when required.
Expert protocols—delivered at your speed, designed to de-risk your study from the start
Before your study begins, our scientists work with you to define every key variable.
You’ll have a detailed, study-ready protocol that sets the foundation for confident execution, covering your study’s technical, operational, and regulatory plan.
What you get
- Needs assessment and protocol planning
- Analytical methods selection or validation
- GLP or non-GLP alignment
- Site training requirements
- Kit specifications (tracer, time points, instrumentation)
- Data output expectations
- Reporting, documentation, and archiving setup
Site training that prevents protocol drift and execution errors
Once your protocol is finalized, we don’t leave execution to chance. We train your teams—internal and external—to run the study exactly as designed, minimizing variability and ensuring site-level compliance.
Our scientists provide tailored education for your study staff, CROs, and site personnel, so every variable is handled correctly from the start.
What you get
- Internal GLP and protocol-specific staff training at Metabolic Solutions.
- CRO and site training for sample collection, handling, and timing.
- Education on unique specimen types (e.g., breath, saliva, cryovials).
- Instructions for proper storage and dose separation.
- Documentation and compliance protocols for multi-site studies.
- Optional creation of a custom Site Manual for standardized execution.
- On-call support for clarification during startup.
Expert protocols—delivered at your speed, designed to de-risk your study from the start
Before your study begins, our scientists work with you to define every key variable.
You’ll have a detailed, study-ready protocol that sets the foundation for confident execution, covering your study’s technical, operational, and regulatory plan.
What you get
- Dose formulation and isotope identification.
- Labeling, documentation, and regulatory specifications (GLP vs. non-GLP).
- Time point planning and collection container prep.
- Return logistics (e.g., shipping materials, pre-addressed labels).
- QA-reviewed SOP-driven assembly with lot numbers and expiration tracking.
- Optional inventory storage in temperature-controlled, secure facilities.
- Direct-to-site or on-demand shipping based on study timeline.
Validated stable isotope assays, built for reproducibility and regulatory trust
Whether you need a standard assay or a custom-developed method, Metabolic Solutions delivers high-precision analysis with full GLP compliance. Every sample is tracked, verified, and designed for stable isotope tracer studies.
From the moment your specimens arrive to the delivery of raw data, our workflows protect sample integrity, analytical accuracy, and regulatory alignment.
What you get
- Assay selection from our validated test library.
- Method development and validation for novel protocols.
- Sample intake verification with unique identifiers.
- GLP-compliant stable isotope analysis by trained staff.
- Real-time resolution of sample issues by Study Director.
- QA-controlled instrument calibration and data integrity checks.
- Optional secure sample and data storage with.
- 24/7 temperature monitoring.
- Daily backups and generator protection.
- Chain-of-custody documentation.
From complex data to clear, validated endpoints
Data is only as useful as your ability to interpret it. We simplify complex enrichment data into validated, study-ready outputs—using regulatory-compliant models and customized calculation tools that align with your protocol goals.
Whether you're modeling breath curves or translating enrichment ratios into physiological meaning, our team ensures your data tells the right story, clearly.
What you get
- Pre-built, study-specific spreadsheet models (e.g. gastric emptying curves).
- CFR Part 11–validated calculation tools.
- Simplified, interpretable data outputs aligned to protocol endpoints.
- Support for custom calculations beyond standard units.
- Ongoing scientist-to-scientist dialogue for interpretation.
- Real-time data clarification during or after analysis delivery.
Validated stable isotope assays, built for reproducibility and regulatory trust
Whether you need a standard assay or a custom-developed method, Metabolic Solutions delivers high-precision analysis with full GLP compliance. Every sample is tracked, verified, and processed in a purpose-built lab designed for stable isotope work.
From the moment your specimens arrive to the delivery of raw data, our workflows protect sample integrity, analytical accuracy, and regulatory alignment.
What you get
- Final Bioanalytical Report formatted for clinical submission.
- Study director, QA, and analyst signoffs.
- Executive summary with study context.
- Description of stable isotope analysis methods performed.
- Detailed results and interpretation structure.
- SOPs referenced and deviations documented.
- Quality control and traceability data.
- Formatting aligned for database upload or integration.
- Secure data delivery via web portal when required.
Metabolic Solutions, LLC.
460 Amherst St., Nashua,
NH 03063, USA
Fax: (603) 598-6973
Hours of Operation
Monday – Friday
7:30 am – 6:00 pm EST
