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Monday, January 25, 2010
Facilities at Azidus CRO...
AZIDUS is committed to deliver quality services that meet the high expectations of its customers to their total satisfaction by providing its employees with necessary tools and resources.
Azidus has high level of competency and experience in delivering clinical research services including BA/BE studies and all phases of clinical trials. Azidus provides a platform where highly qualified technical personnel and latest advancements in clinical & analytical field get united to deliver the needs of pharmaceutical and biotech companies. The Azidus team executes projects with strict timelines with the sole objective of satisfying customer needs. Azidus maintains Excellence in every service provided, coupled with ethics, innovation and dedication.
Azidus has high level of competency and experience in delivering clinical research services including BA/BE studies and all phases of clinical trials. Azidus provides a platform where highly qualified technical personnel and latest advancements in clinical & analytical field get united to deliver the needs of pharmaceutical and biotech companies. The Azidus team executes projects with strict timelines with the sole objective of satisfying customer needs. Azidus maintains Excellence in every service provided, coupled with ethics, innovation and dedication.
Tuesday, January 5, 2010
Full service CRO - AZIDUS
Azidus Laboratories Ltd., is a full service Contract Research Organization (CRO) committed to cater to the technical needs of global Pharmaceutical and biotech enterprises.
The technical expertise in Azidus will deliver high quality clinical and bio-analytical services in the areas of Bioavailability / Bioequivalence (BA/BE) studies and clinical trials including phase I to IV.
The facility has been approved by the Drugs Controller General of India (DCGI).
The technical expertise in Azidus will deliver high quality clinical and bio-analytical services in the areas of Bioavailability / Bioequivalence (BA/BE) studies and clinical trials including phase I to IV.
The facility has been approved by the Drugs Controller General of India (DCGI).
Sunday, January 3, 2010
Clinical Research Organization
A Contract Research Organization, also called a Clinical Research Organization, (CRO) is a service organization that provides support to the pharmaceutical/biotech industry. CROs offer clients a wide range of "outsourced" pharmaceutical research services to aid in the drug and medical device research & development process. In the Code of Federal Regulations (CFR), the U.S. Food and Drug Administration regulations state that a CRO is "a person [i.e., a legal person, which may be a corporation] that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the Food and Drug Administration."
Services offered by CROs include: product development, formulation and manufacturing; clinical trial management (preclinical through phase IV); clinical, medical and safety monitoring; preclinical, toxicology, and clinical laboratory services for processing trial samples; data management, biostatistics and medical writing services for preparation of an FDA New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA); regulatory affairs support; and many other complementary services. CROs range from large, international full service organizations to small, niche specialty groups and can offer their clients the experience of moving a new drug or device from its conception to FDA marketing approval without the drug sponsor having to maintain a staff for these services.
http://en.wikipedia.org/wiki/Contract_research_organization
Services offered by CROs include: product development, formulation and manufacturing; clinical trial management (preclinical through phase IV); clinical, medical and safety monitoring; preclinical, toxicology, and clinical laboratory services for processing trial samples; data management, biostatistics and medical writing services for preparation of an FDA New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA); regulatory affairs support; and many other complementary services. CROs range from large, international full service organizations to small, niche specialty groups and can offer their clients the experience of moving a new drug or device from its conception to FDA marketing approval without the drug sponsor having to maintain a staff for these services.
http://en.wikipedia.org/wiki/Contract_research_organization
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