Clinical Research Support

CRO services

Microcoat’s Laboratory Services facility works as an independent Contract Research Organization, supporting you in all stages of clinical development. We are unique in our capability to develop, manufacture and perform custom assays. We provide a diverse range of validated assays and offer the validation of custom assays. We can accommodate to any study size: low, medium, or high volume sampling requirements. Our Custom Development department is co-located to our Bioanalytical Services facility enabling close collaboration and smooth technical transfer for new assays from development to sample measurement.

Our Services

Our laboratory services are supported by a broad range of technologies including ELISA, cell-based assays, colorimetric assays, PCR, HPLC, and spectroscopy.

Bioanalytical services

We provide early phase development services (non-GLP), pre-clinical testing services (GLP/GC(L)P) and clinical testing service (GC(L)P/cGMP). We help you to plan the tests and keep in constant communication with you during the testing period. Data analysis and compilation is performed according to your requirements.

Assay development
Assay validation
Pharmacokinetics
Immunogenicity
Non-clinical and clinical sample measurement
Endotoxin and Pyrogen testing

Sample storage and aliquoting service

Our laboratory receives non clinical and clinical samples from around the world. The samples are logged into our system and stored at their appropriate temperature. Storage for a couple of months up to years is part of the service we offer in combination with the analysis of samples. The storage conditions have been designed in order to provide a very high degree of convenience and safety for our clients.

Aliquoting according to analytical plan to avoid repeated freeze/thaw cycles
Storage at -80 °C, -20 °C, 2-8 °C and ambient temperature
Alarm secured permanent temperature monitoring with instant messaging of deviations
Emergency power generator for -80 °C freezers
SOP regulated temperature control and archiving of electronic and hard copy monitoring data

After completion of the analytical process, specimens are stored frozen as long as the client requests. Samples are returned or disposed only in agreement with our customers.

Lab-kit supply

Customers benefit from our capability to provide them with their assay as a complete kit to be used on-site in their study. Kits may for example be used for entering patients into trials or monitoring biomarkers. Lot sizes from 10 – 10,000 kits can be produced in our Contract Manufacturing facility. Coating of microplates, lyophilization, filling and packaging is done in-house, based on over two decades of diagnostic kit development and manufacturing. Our facilities stay in close contact guaranteeing an easy transfer from development to routine manufacturing.

Experience in the support of pre-clinical and clinical trials, development and evaluation studies
High degree of flexibility to keep your timelines without compromising quality
Our teams work as an extension of yours
Close communication as a key to success
Optional on-site training of our people in your facility
Customized reporting

Our facilities stay in close contact guaranteeing an easy transfer from development to routine manufacturing.

Have a look:

GLP test facility

Our services are conducted in line with international guidelines

GLP test facility

Our services are conducted in line with international guidelines

Diagnostic kit production

DNAse/RNAse/Endotoxin-free

reagent supply, lyophilization, filling and packaging

Diagnostic kit production

DNAse/RNAse/Endotoxin-free

reagent supply, lyophilization, filling and packaging

Did you know...

...Microcoat offers Low Endotoxin Recovery and endotoxin demasking studies for biopharmaceuticals?

Did you know...

...Microcoat offers Low Endotoxin Recovery and endotoxin demasking studies for biopharmaceuticals?