Our laboratories

ADME

We bring over three decades of GLP-accredited excellence to support our pharmaceutical clients throughout the drug development cycle, from pre-clinical to post-marketing studies.

Our comprehensive suite of pre-clinical and clinical DMPK services for both small and large molecules is built to meet the highest standards of scientific and regulatory excellence. 

We also partner with leaders in the agroscience, cosmetic, and chemical industries, delivering robust bioanalytical support and safety assessments for topical and dermal products.

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We have the expertise to conduct studies on small molecules, large molecules, and antibody-drug conjugates, utilizing a range of analytical platforms : LC-MS/MS, immunoassays, and cell-based assays.

Custom immunoassays, ADA/NAb testing, biomarkers & PK/PD: agile, GLP-compliant bioanalysis tailored to the development of biologics.

In-vivo studies to identify the most promising drug candidates based on bioavailability and PK profiles, prior to initiating GLP-compliant pre-clinical studies. Radiolabelled or cold test item.

We offer GLP-compliant biomarker services from development to validation, providing reliable data with advanced technologies and expertise to support every phase of your projects.

Topical product development, IVRT/IVPT, skin PK, bioequivalence & radiolabel studies under GLP/OECD/SCCS – for pharma, cosmetics & dermal product bioanalysis.

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We are a biologics-focused, global leader in bioanalytical solutions providing over 25 years of industry-leading scientific expertise. We specialise in comprehensive PK/TK, ADA, NAb, biomarker assays and sample analysis for the world’s largest pharmaceutical and biopharmaceutical companies. 

 

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Development, Transfer, Validation & Sample Analysis: mAbs, ADCs, fusion proteins, DARPS, bispecifics, enzymes, oligos, PEG products, viral vectors, vaccines, gene therapies, biosimilars, CAR-T

Extensive ADA and NAb method development, validation, and analysis using diverse platforms to ensure drug tolerance and high sensitivity for even the most difficult assays.

We tailor biomarker assay development, validation, and analysis to your needs—using kits, de novo methods, or multiplex solutions to meet regulatory standards.

Support a wide array of cell-based assays for the evaluation of NAbs to immunophenotyping, and cell activation utilizing flow cytometry, cell culture, ELISpot, and other methodologies.

GLP and GCLP assay development, validation and sample analysis for qPCR assays in support of biodistribution, vector shedding, and PK endpoints.

Expertise in PK and ADA assays for biosimilars, with access to select originator assays for starting points for PK and ADA method development.

Optimed recruitment

With 35 years of experience in early-phase clinical trial management and more than 1000 successfully conducted studies, we offer the expertise of our team to guarantee the success of your projects. Our flexibility and reactivity are major assets in your product development. A single point of contact will support you every step of the way, from manufacturing to clinical trial.

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Our scientists and medical experts provide strategical and methodological advice based in order to help you plan coherent and robust studies, mitigate risk and optimize resources.

Our regulatory experts continuously monitor country-specific regulatory and ethics restrictions, requirements and liaise with all relevant stakeholders so that submissions are always fully compliant.

Strategically located in Grenoble, France, our facilities are exclusively dedicated to conducting clinical trials in healthy volunteers and in ambulatory patients with all needed medical equipment.

Whether you intend to conduct a single-country single-site or an international multi-centre study, we can take responsibility for every aspect of it.

Translate your clinical practice into data-driven conclusions

With 35 years of experience in early-phase clinical trial, our medical team's expertise is a key advantage to the sucess of your project, wheter in Europe or abroad.

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For over 40 years, we’ve helped our clients advance Phase 1-4 clinical trials with complex/esoteric testing and assay development. Our validated test list includes more than 3,000 assays, with new custom assays developed on a continual basis in response to client needs. We specialise in molecular infectious disease testing, vaccine safety and efficacy assessment, immunogenicity, cell-based assays, allergy/hypersensitivity, and biomarker analysis.

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Custom development, validation and optimization of qPCR and genotyping assays; multiple-target, dual gene assays designed to eliminate risk of false negatives/under-quantified viral loads.

Broad based experience with complex immunoassays using multiple platforms and assay types, PBMCs with both infectious disease and cancer vaccine antigenic stimulation, and cell-based assay/analysis.

Plate-based, Cell-based Testing (ADA/NAb), Clinical Trials (FIH – Ph3) Bridging, Competitive, Acid Dissociation, Traditional, dsDNA, Gene & Cell Therapies, TCID50, Plaque, Live-cell, ELISpot, CMI

Custom qPCR & ddPCR, RCR/RCL PCR safety testing, Next generation sequencing (NGS) & comprehensive genomic profiling w/biostatistics, nanoString, Whole genome (WGS), Whole exome (WES), RNASeq

A comprehensive technology portfolio providing custom assay design, validation, and analysis for PCR, ddPCR, Sanger, NGS (WGS, WES, RNASeq, somatic testing, nanoString, flow cytometry & more.

ADA, NAb, viral shedding, biodistribution, qPCR, ddPCR, ELISA, ELISpot, flow cytometry, vaccines, CAR T, CRS, MSD, whole exome, RNA, Luminex, NGS, immunoassay, gene expression, ligand-binding assays