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TMI takes great care to manage each study with extraordinary adherence to protocol and execute all activities to minimize any chance of slippage of timelines. In the Study Startup phase, typical TMI activities include: Drug Controller General, India, (the equivalent of the FDA in India) filing and approval; IRB filings and approvals or contingent approvals; investigator selection, contracting and training; lab selection contracting, and validation.

TMI frequently provides these services to our clients, organizing these activities in consultation with our clients own regulatory and QA staff. TMI has significant expertise, experience and relationships related to:

* Applying for and obtaining DCGI approval
* Institutional review board (IRB) or Ethics Committee approval
* Informed consent, including translation into local languages as necessary
* Drug import license, chain of custody, drug import, special handling
* Site/investigator selection and contracting
* Selection and management of central lab
* Protocol optimization for India specific advantages


FDA/EMEA acceptance of data for India is well established, but not to be taken for granted. TMI assures high compliance with ICH GCP and all relevant national and international standards and that sponsors are provided with all documents requested for filing and submissions.