The clinical trials team at Cliantha provides expert clinical management with Biosimilar Clinical Trials. We can plan and run your global clinical trial or conduct the Indian arm of your trial. Our team has completed work successfully for the Indian regulatory authority as well as for FDA and EMA. Our database of more than 400 oncologists and 1500 Investigators in other specialties allows us to achieve the recruitment rate in the best possible times
Cliantha offers GLP compliant immunoassays. The bioanalytical services include GLP compliant assays for peptides, proteins, monoclonal antibodies (mAB) under FDA and EMA regulations. We utilize the following platforms:
- Clot based assays
- Flow Cytometry
We have validated methods for
- Levothyroxine and
- Tri - iodo thyronine
- Low molecular weight heparin (assessment of its pharmacodynamic parameters)
- anti – factor IIa
- anti – factor Xa/li>
We have developed methods for
- Peg GSF
Being a CAP accredited lab, with FDA and EMA experience puts the lab in a unique position to cater to the needs of biomarker assessments.
ELISA, Flow Cytometry, ECLIA, CMIA, end point assays, kinetic assays, clot based assays
Our expertise spans the therapeutic spectrum and includes the markers for:
- Autoimmune diseases
- Metabolic disorders
The team has been regularly presenting at international conferences –
Poster titled "Challenges in estimation of FSH for pharmacokinetic study by Architect i1000 (CMIA based clinical lab instrument)and commercial kitss" which won the best poster award at the 10th WRIB at Orlando in Apr’16.
Poster titled "An acid dissociation Bridging ADA assay for immunogenicity assessment of Bevacizumab" in Annual Immunogenicity and Bioassay summit held in Baltimore, MD, USA, Nov 15.
Poster titled 'ELISA assay for determination of bevacizumab (pharmacokinetic) VEGF– A (pharmacodynamic), and immunogenicity assessment' at the 9th WRIB (Workshop on Recent Issues in Bioanalysis) in Miami, Florida in Apr '15.