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Clinical Trail Management

Clintrac provides complete quality solutions to clinical research projects for pharmaceuticals and biotechnology companies. Clintrac has a credible  track record of conducting  clinical trial (both national and global) in different therapeutics area such as Psychiatry, Oncology, Pulmonology, Cardiovascular and Diabetics. Clinical trials on vaccines and herbal products have also been undertaken.

Our activities include:-

  • Study designing and its feasibility.
  • Site Identification for phase trials.
  • Volunteer Recruitment through Database.
  • Sponsor and IRB/IEC Correspondence.
  • Randomization, Dispensing, coding and labeling of Investigational Product and archival
  • Study Initiation and developing  and maintaining a well trained team.
  • Patient Recruitment including Counseling, Education and Retention.
  • Site Monitoring.
  • Source Data Verification and Compliance Audit.
  • Study Termination and Close Out.
  • Reporting of SAE to Sponsor, EC and Regulatory Authorities as per the Schedule Y.
 

BA/BE Services

Clinical Pharmacological Unit: Clintrac has a 40-bedded well equipped DCG(I) approved GCP compliant clinical facility. It is capable of undertaking a wide variety of clinical studies including

  • Bioavailability/Bioequivalence studies with different formulations, different dosage forms.
  • Pharmacokinetics (PK)
  • Food effect
  • Drug- Drug Interaction,
  • Steady State,
  • Studies with light sensitive molecules.
Clintrac BA/BE facility is maintained by a group of GCP-Trained, well experienced Clinical Research Scientists and qualified technicians. Clintrac is committed to high Quality Bioavailability and Bioequivalence Research in line with  Ethical Standards and Regulatory Provisions.
 

Infrastructure: BA/BE Clinical Facility

  1. GCP compliant DCGI approved fully equipped 40-bedded air conditioned clinical pharmacological unit.
  2. Spacious volunteers housing area.
  3. Access controlled government licensed pharmacy with well controlled temperature and humidity ideal for the storage of  investigational products.
  4. In house dining and recreation area for volunteers.
  5. CCTV monitored clinical facility to identify for any Adverse Event and to treat them at the Earliest.
  6. Well equipped in-house ICU in addition to ICU of Vydehi Hospital located in the vicinity of the clinical facility.
  7. Well equipped area for dosing, sample collection / separation areas  with controlled temperature  refrigerated centrifuge.
  8. Separate Sample Storage Room with minus 80º C Deep Freezer.
  9. Yellow Mono-chromatic lights for trials involving light sensitive molecules.
  10. Constant updated in-house Volunteer Database.
  11. Independent Ethics Committee/ Institutional Review Board (IEC/IRB).
 
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