Clinical Research

 

Ethix Pharma provides services related to support clinical trial conduct. The services are customized to sponsor’s requirements and we look to enable our clients to perform to their best potential. We support to streamline their activities and extend their geographic coverage.


We achieve this through our:

Network of experienced physicians across India, which is continuously expanding.
Large and diverse patient population with a positive attitude towards clinical research.
Dedicated full time certified clinical research coordinators.
Integrated project management offers sponsor immediate access to several pre-qualified investigators in all      therapeutic segments.
E-D3 (Ethix demographic disease databank); a proactive initiate to identify regional patient population for focus      therapeutic segment.
ACE-trial (Active coordination in ethical trail process); proactive assistance in EC registration, compliance and      approval.

 

 

Clinical Service Include

  • Trial Feasibility


    Site feasibility studies
    Site selection and evaluation
    Collection of essential documents
    Investigators’ meetings
    Documentation procedures, such as Trial Master File Management, central investigator file and investigator     site file
    Investigator Grants Management
  • Medical Writing


    Complete literature review and meta-analysis
    Statistical planning (sample size estimation, randomization, and power calculations)
    Case Report Form (CRF) design and guidelines to fill-in
    Informed consent form (ICF)
  • Site Initiation and Training


    Staffing with trained and experienced CRCs
    Patient recruitment support
    Investigational Product (IP) Management
    Training on IP, lab handling procedures, ECG, etc.
    Logistics management
    Site specific Standard Operating Procedures (SOP's)
    On-site developmental briefing of Investigators and research team

  • Clinical Monitoring


    Patients follow up
    Tracking CRFs
    Regulatory compliance
    Site Quality Assurance
    Maintenance of Site documents
    Resolution of queries
    Research site liaison
    Progress and status reports
    Resolution of issues like Serious Adverse Event and DCFs within timelines

Services & Facilities

     
  Clinical Research
  Medico-regulatory
  Discovery Biology
   

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