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PHARMACOKINETIC STUDIES

CLINEXEL Team members have extensive experience in Pharmacokinetic studies in healthy volunteers and patients. Cumulative experience of the team spans ~800 studies for various markets, including PK studies in healthy volunteers, patients for Long Acting Injectables, biosimilars and inhalation products.

Our strengths include strong Project Management and Experience in handling time sensitive projects

  • Team members have experience with different formulations including injectables, rectal suppositories, local applications, inhalation, transdermal, nasal sprays, intravaginal tablets and suppositories. Team members experience also includes pharmacokinetic studies in patients for Long Acting Injectables and Oncology drug and pharmacokinetic studies for biosimilars and inhalation products.
  • Clinexel Team has experience of scientific advice meetings with different regulators (EMA/ FDA/ TGA/ PMDA/ Health Canada) followed by successful trial conduct and approval
  • Regulatory approval process is also streamlined. Regulatory timelines are 90 days, however, in our experience, a well compiled, complete dossier submission facilitates faster regulatory approval- in practice 15- 45 days, along with NOC for import
  • Our clinical trial sites network in India has extensive experience in clinical and BE studies in – Oncology, Psychiatry and Dermatology and have successfully contributed to regulatory approvals globally.
  • GCP inspections have been conducted at these sites. Data from India is high quality and acceptable to all major regulators for approvals
  • Respiratory and Ophthalmology clinical trial sites in India are also developing rapidly
  • For conducting these studies in India we are supported by the large patient pool in India that includes large, diverse, therapy-naïve as well as treatment failure patients. There is a large patient population in both acute & chronic disease conditions.
  • For conducting these studies in India we are supported by the Clinical Research Infrastructure in India that includes over 100 BA/BE Centers, over 200 medical colleges, over 22000 graduates, approx. 15000 hospitals and 9 lakhs hospital beds, with over 75% of these in urban areas, approx. 14000 diagnostic labs, ~around 7 lakh scientists and engineering graduates per year, World class medical / laboratory facilities at secondary/ tertiary care centers and skilled computer-savvy biomedical workforce at clinical trial sites
  • For conducting these studies in India we are supported by the large patient pool in India that includes large, diverse, therapy-naïve as well as treatment failure patients. There is a large patient population in both acute & chronic disease conditions.

CLINEXEL is a professionally managed private limited company, a CRO led by experts with experience in leadership positions in pharma and biotech companies .

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