Phase I First Time in Human Studies | Clinical Trial Material Production

Novel OSD Services • Clinical • Phase I & FTIH

Phase I & FTIH

Metrics Contract Services offers tailored and timely solutions to guide you to and through your first clinical study. For Phase I, First-time- in-Human (FTIH) studies we offer Clinical Trial Material batch sizes from benchtop scale to pilot scale and beyond. This flexibility allows Metrics to adapt to the needs of your study size. If required, we can also work at miniature scales to conserve API.

Tailored Approach

Metrics Contract Services takes different approaches to First-in-Human studies depending on the desired result:

Active Pharmaceutical Ingredient (API)-in-Capsules – Using our Xcelodose®600S encapsulator, we can fill API directly into a capsule with high precision and accuracy over a dosage range of 1 mg to 250 mg.
Blend and Fill – Based on the physical and chemical properties of your product, Metrics has the ability to develop a basic blend of ingredients to help with manual or semi-automated capsule filling.
Tablets – We may suggest a tablet formulation as the best approach to developing a Phase I dosage form.

We are well-versed in handling highly potent compounds, using hard-wall isolation technology for batch sizes up to and engineered solutions for larger batches. We house manual or automated bottle packaging lines to support your clinical trial preparations.

Customer-Centric Clinical Manufacturing

Metrics approaches First-in-Human projects with our customers’ critical milestones in mind:

From receipt of API to shipment of clinical trial materials, our typical delivery timeline is 3-5 months*.
A Project Lead is assigned to ensure both companies meet the mutually agreed project goals and maintain continuity throughout your program.
Customers are encouraged to engage technically with our development and analytical laboratory staff to fully understand the scientific aspects of the work.

*Some projects could take longer depending on the development complexity.

All clinical trial materials are supported by our comprehensive analytical services.

Get ahead of your timelines with our team today