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Clinigene Profile


Clinigene International

Clinigene: India’s most experienced Biologics CRO
Clinigene is a full-service CRO for end-to-end clinical development of biopharmaceutical drugs, with extensive experience on novel biologics and biosimilars.
Our Services

• Early phase studies: Dose Escalation, TQT, DDI and PK studies in special populations
• Laboratory services: Central Lab, Biomarker analysis, immunoassay and cell-based assays
• Late phase clinical development – extensive experience in Oncology, Diabetology and Immunology

Our facilities (early phase clinic, bio analytical lab and central lab) have been inspected by several regulatory agencies, incl. US-FDA and EMA. Our immunoassay lab is GLP and GCLP compliant.
Therapeutic Experience (partial list)
Oncology:

• Solid Tumors
• Non-Small Cell Lung Cancer (NSCLC)
• Glioma
• Head and Neck Cancer
• Non-Hodgkins Lymphoma (NHL)
• Metastatic Breast Cancer
• Treatment-related complications

Diabetology

• Type 1 & 2 Diabetes mellitus
• Complications (Diabetic foot ulcer, Neuropathy, Nephropathy)

Orthopedics

• Osteoporosis
• Chronic low back pain

Nephrology

• Chronic Kidney Disease (CKD)
• Anemia in CKD

Rheumatology

• Rheumatoid arthritis

Why Clinigene? Why India?

• Clinigene has conducted over 200 clinical trials involving more than 11000 patients and healthy volunteers.
• Clinigene has relationships with a large number of GCP certified investigators throughout India
• Oncology – 96
• Diabetes – 120
• Clinigene’s investigator database includes internationally known KOLs
• Extensive experience in working with American and European Sponsors
• India has large treatment naïve patient populations in TAs such as oncology, Diabetology, metabolic disorders and CNS.
• India has the best recruitment and retention rates amongst emerging markets
• English Speaking investigators and staff
• Cost Savings of 50% relative to US and Europe