Clinigene is a full service CRO offering end-to-end clinical development solutions with an emphasis on novel biologics and biosimilar compounds.

Our Services

Clinigene has a decade of experience providing clinical development solutions for novel biologicals and biosimilars including the following:

• Early Phase studies including pharmacokinetic and pharmacodynamic studies in both healthy volunteers and patients
• Bioanalytical laboratory services including immunoassays for PK and Immunogenicity
• Clinigene is the only CRO in India with an in-house GLP / GCLP compliant Immunoassay / Bioanalytical laboratory
• Late Phase clinical development - extensive experience with Biologics in Oncology and Diabetology
• Central Lab services, including biomarker assays

Our Early Phase clinic and bioanalytical laboratory have been inspected by US FDA (without 483's) and EU authorities.  The Central Lab is CAP certified and one of the clinical sites monitored by Clinigene in India has been audited by the US FDA.  A significant portion of our completed clinical development projects have been in the biological space.

Therapeutic Experience

Why Clinigene? Why India?

• Clinigene has relationships with a large number of GCP certified investigators throughout India (Oncology = 96 and Diabetes = 120)
• Clinigene's investigator database includes internationally known KOLs
• Clinigene's Project Management and Monitoring staff has extensive tenure and low turnover.
• Key management team has worked with multi-national Pharma and CRO companies and are keenly aware of sponsor needs.
• Clinigene has conducted over 50 Late Phase trials involving 200 sites and more than 6000 patients.
• India has large treatment naive patient populations in therapeutic areas such as oncology, diabetology, metabolic disorders, immunology, and CNS.
• India has the best recruitment and retention rates amongst emerging markets
• Cost savings of 50% relative to US and Europe
• English speaking investigators and staff
• Extensive experience in working with US Sponsors