Solutions

CRO

CRO implies a Contract Research Organization which is also known as a Clinical Research Organization. This is a service based organization providing business support to the pharmaceutical and biotech industry. In order to assist in the research and development of all kinds of medicines, medicaments, drugs and medical devices, CROs aim to provide their clients with an extensive variety of outsourced pharmaceutical research services.

The essential services provided by CROs comprise of the following:

  • Product Development
  • Formulation and Manufacturing
  • Clinical Trial Management (preclinical through phase IV)
  • Clinical, Medical and Safety Monitoring
  • Preclinical Toxicology
  • Clinical Laboratory Services for processing trial samples
  • Data Management
  • Biostatistics and Medical Writing (Medical Transcription) Services for preparation of an FDA New Drug Application (NDA)
  • Abbreviated New Drug Application (ANDA)
  • Biologics License Application (BLA)
  • Regulatory Affairs Support

In addition the all the above many other complementary services are also provided by the CROs.

As business process organizations, CROs vary in size and nature of services. Large CROs are international organizations providing comprehensive services to their clients and small CROs also known as niche specialty firms which provide the their services to develop a new drug or medical device from its conception to FDA marketing approval without the client having to employ special staff for any of these tasks.

Glisten Pharma feels proud to have built strong business relationships with leading CROs in the world to assist the developing global pharmaceutical industry. The key functions of Glisten Pharma are to acquire product specs and price comparisons from these CROs and arrange the most competitive prices and quality for its valued clients.