Clinical Lifecycle Management

  • Clinical Lifecycle Management 1
  • Clinical Lifecycle Management 2
  • Clinical Lifecycle Management 3
Product Description

We offer a range of GCP services, from monitoring to audits. Providing comprehensive GCP compliance services for the pharmaceutical industry is one of our specialties.

A.   Risk-Based Monitoring: 

✔ Risk-Based Monitoring for Bioequivalence/Bioavailability Studies (BE/BA Studies)

✔ Risk-Based Monitoring for Phase-I Studies.

✔ Risk-Based Monitoring for Patient-Based PK/PD Studies.

✔ Risk-Based Monitoring for Late Phase Clinical Trials (Phase-II, Phase-III, Phase-IV)

✔ Expert Monitoring for Bioanalysis (including In-Process and Retrospective)

✔ Expert Monitoring for PK-Stat (Pharmacokinetic Statistics)


B.      Audits: 

✔ CRO Qualification/Requalification Audits

✔ Pre-Inspection readiness Audit/Mock-Inspection

✔ For-Cause Investigative Audit

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Zenovel

  • Country/Region:
    India
  • Founded:
    2020
  • On CPHI since:
    2021
  • Certificates:
    1
  • Employees:
    25 - 49
Company types
Consultancy
Contract Service
Start-up
Primary activities
Biopharmaceutical
Clinical Research
Medical Devices
Other
Regulatory Affairs
View company profile
Categories
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Specifications
  • Details
    GCP audit and monitoring services for BA/BE studies, Phase I studies, patient-based PK/PD studies, and Phase II–IV clinical trials. Applicable for sponsors, CROs, pharmaceutical companies, and biotech companies requiring independent clinical study oversight, CRO qualification, site audit, bioanalytical monitoring, and inspection readiness support.
  • Selling Points
    Brand Name; Convenience; Experienced Technicians; Guarantee/Warranty; Quality Service; Reputation; • Independent GCP audit and monitoring support for sponsors and CROs
    • Experience in BA/BE, Phase I, patient-based PK/PD, and Phase II–IV clinical studies
    • Risk-based monitoring approach focused on critical data and subject safety
    • CRO qualification and requalification audit support
    • Investigator site audit and clinical site monitoring support
    • Bioanalytical monitoring and retrospective study data review
    • QA audit, for-cause audit, and inspection readiness support
    • Sponsor oversight support for outsourced clinical research activities
    • Practical, compliance-focused, and regulatory-aligned service delivery

  • Model
    Clinical Research/Trials
  • Supplied from
    India
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Sales Markets
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Zenovel

  • Country/Region:
    India
  • Founded:
    2020
  • On CPHI since:
    2021
  • Certificates:
    1
  • Employees:
    25 - 49
Company types
Consultancy
Contract Service
Start-up
Primary activities
Biopharmaceutical
Clinical Research
Medical Devices
Other
Regulatory Affairs
View company profile

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