Monitoring of Bioequivalence studies & Medical Monitoring

Monitoring of Bioequivalence studies & Medical Monitoring
Product Description

Monitoring Services - Built as per ICH GCP E6 R2 and other international applicable regulatory standards. Customized to bioequivalence and early phase studies in normal healthy volunteers. Extensively experienced monitoring team for Clinical and Bioanalytical. 

Medical Monitoring - Built as per ICH GCP E6 R2 and other international applicable regulatory standards. Expert medical panel across therapeutic areas and medical specialties including oncology, immunology, infectious disease, renal, cardiology and allied medical specialties. Team experienced in early phase and first in human studies both in patients and healthy volunteers. 

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ARKUS RESEARCH PRIVATE LIMITED

  • IN
  • 2023
    On CPHI since
  • 1 - 24
    Employees
Company types
Consultancy
Contract Research Organisation (CRO)
Contract Service
Other
Primary activities
Clinical Research
Contract Research Organisation
View company profile
Categories
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Specifications
  • Details
    Monitoring of Bioequivalence studies, Early phase studies and PK studies in patients. The services provided as per the client approved monitoring plan followed by detailed monitoring report.
    Medical Monitoring and Review - Pre-study document review and medical inputs, in study medical monitoring and oversight.
  • Selling Points
    Quality Service; Reputation; Small Orders Accepted; Experience with one-on-one regulatory interactions, multiple markets, very high-quality deliverables. 
  • Model
    On site & remote
  • Supplied from
    India
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Sales Markets
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ARKUS RESEARCH PRIVATE LIMITED

  • IN
  • 2023
    On CPHI since
  • 1 - 24
    Employees
Company types
Consultancy
Contract Research Organisation (CRO)
Contract Service
Other
Primary activities
Clinical Research
Contract Research Organisation
View company profile

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ARKUS RESEARCH PRIVATE LIMITED resources (1)

  • Arkus Research Private Limited

    Brochure Arkus Research Private Limited

    Arkus Research is an India based service provider for Monitoring, Audits and Vendor Qualification for bioequivalence studies. Additionally, we provide Medical Monitoring, Support for regulatory queries and Document preparation (USFDA), QMS assessment and RWE strategy and solutions. The Arkus team is a well experienced team with a very sound understanding of operational and regulatory requirements of your studies.

    Reach out to us for compliant, effective solutions with a focus towards excellence.