Clinical trial and Bioequivalence

NUVO provides best solution partner for your Clinical trial and Bioequivalence requirement.We do a detailed analysis of the products and its requirement for BE study and Clinical trial with the client team. We support with complete study and its auditing and monitoring services for our clients.

Support and assistances in following studies:

  • BA BE
    • Healthy Volunteer Studies
    • Patient-Based Studies
  • Clinical Trials
    • Early Phase Clinical Trials
    • Late Phase Clinical Trials
  • Special Studies
    • Inhalation
    • Suppository
    • Glucose Clamp
  • Biosimilars & Biologicals
  • Biopharmaceutics & Project Management

Following are in brief support we provide:

  • Clinical research organization (CRO) or bio study site identification
  • Auditing of the CRO
  • Monitoring of the clinical study and bio study
  • Project management for support and co-ordination for complete study
  • Clinical studies from proof of concept to global submissions
  • Clinical trial, Bioequivalence and bioavailability strategy and design
  • Customized studies for challenging drugs requiring complex designs and/or special attention towards safety parameters.
  • Clinical data management and biostatistics
  • Bio-statistics & Statistical Programming
  • Medical writing & safety
  • Bio analytical services support for developing and validation of the methods
  • Solutions for pharmacokinetic and statistical analysis by using various tools
  • Regulatory support including e-CTD compliant dossier submissions
  • Assistance in resolving regulatory queries
  • Support in seeking regulatory authority permissions
  • Support for archiving of records along with sample retention as post study services
  • Support for hormones, endogenous substances, elemental formulations and locally administered products) besides oral solids/liquid dosage forms,
  • Full assistance in pro-drug analysis, parent–metabolites simultaneous assays, chiral analysis, elemental analysis, hormones and endogenous substances
  • Compliance as per current GCP/GLP and respective health regulatory guidelines
  • Team of clinical investigators, analytical investigators, quality assurance, regulatory affairs, biostatisticians and project management professionals

Facility and Instruments

  • 200+ Beds for trials
  • Sample storage facility at various required temperatures.
  • LC-MS/MS,
  • ICP-OES and ICP-MS
  • mass spectrophotometers,
  • Waters Xevo-TQS coupled with UPLC and ICP-OES
  • Accredited Clinical pathology labs by the College of American Pathologists (CAP) and National Accreditation Board for Testing and Calibration Laboratories (NABL),
  • Our lab can facilitate tests for biochemistry, hematology, urine chemistry and serology
  • Database of 20,000+ volunteers

For Business Query and Discussion