About us

Founded in 2004, CliniRx is a full-service CRO, conducting multinational clinical trials for pharma, biotech and medical devices companies around the world.

Between our Indian headquarters, operational presence in the US and several leading partnerships, CliniRx is particularly well placed to cover key geographies.

CliniRx has experience in several therapeutic areas, with an extensive track record in CNS. CliniRx has extensively dealt with the US FDA, EMA, DCGI and other national regulatory bodies. CliniRx has also held IND of few molecules.

Backed by a large Indian conglomerate, CliniRx has the stability and ability to ramp up across geographies.

To help new molecules reach to the market by offering a flexible experienced team, which acts as an extended arm of the sponsors

MISSION

To become a preferred mid-sized CRO offering value-added services in a cost effective manner

VISION
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Services

CliniRx provides an accountable, flexible, integrated, seamless and efficient platform for result oriented clinical research.

This model increases quality and speed while significantly reducing the cost of the whole program.

  • Regulatory consulting
  • Local applicant support
  • Quality and data driven regulatory applications:
    Clinical Trial Permission, Test License, Marketing
    Authorization, Manufacturing License, Import &
    Registration spanning various products
  • CTRI registration and updates
  • Post approval maintenance
  • Safety submissions
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  • Strategic consulting
  • Project management
  • Vendor management
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  • Project Specific Quality Compliance Assessments
  • Independent GCP/Compliance Audits
  • Standard Operating Procedure (SOP)/Work Instruction (WI) Development
  • Pre-Inspection/Audit Preparation
  • Quality Assurance Trainings
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Team meticulously selects CRAs based on their experience in appropriate therapeutic area.

A strong training program then sets base for the interface between the project team and the Investigator, where CRAs demonstrate high levels of site management skills to ensure that issues at sites are addressed quickly and completely, allowing sites to work efficiently and maximize data quality.

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  • Drug Safety and Pharmacovigilance
  • Medical Monitoring
  • Medical Writing
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CliniRx has an extensive experience in collecting, storing; analyzing, interpreting and presenting critical clinical data. Our preferred partners (global clinical data management experts) are committed to upholding a standardized, process-driven approach by using the state-of-the-art tools such as Medidata, INFORM, etc. Our preferred biostatistics partners are able to demonstrate the efficacy of a drug and present the results in the clearest way possible. CliniRx complies with ICH/GCP, CFR PART 11, GDPR, and other data protection guideline.

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CliniRx has a well placed team with a scientific and operational experience in a wide array of therapeutic areas.

Psychiatry

CliniRx has scientific and operational expertise in a wide array of therapeutic areas and is always ready to explore new ones.

Oncology

CliniRx has scientific and operational expertise in a wide array of therapeutic areas and is always ready to explore new ones.

Endocrinology

CliniRx has scientific and operational expertise in a wide array of therapeutic areas and is always ready to explore new ones.

Cardiology

CliniRx has scientific and operational expertise in a wide array of therapeutic areas and is always ready to explore new ones.

Infectious disease

CliniRx has scientific and operational expertise in a wide array of therapeutic areas and is always ready to explore new ones.

Gastroenterology

CliniRx has scientific and operational expertise in a wide array of therapeutic areas and is always ready to explore new ones.

Respiratory

CliniRx has scientific and operational expertise in a wide array of therapeutic areas and is always ready to explore new ones.

CliniRx’s key attributes:

  • Experienced team comprised of medical and individuals having a strong scientific background
  • SOP driven approach to Project Management, Medical Affairs, Clinical Operations, Quality Assurance and Regulatory
  • A quality review of the documents and the Quality Assurance Processes
  • Experience with the development compound that will help aid in properly and expeditiously completing the proposed study within the scheduled timeframe.
  • Unified project delivery team for each Sponsor/Project under a single unit leadership, control and project management.

Looking for a accessible, agile and flexible CRO?

Talk to us