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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
 
     
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