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METROPOLIS : Gokula SMO
SMO Philosophy SMO Process Exclusive SMO Sites	OUR SERVICES As a unique Site Management Organization , Gokula Metropolis Clinical Research Centre brings cutting edge processes to the marketplace to ensure the successful and timely results of your clinical trials. Concept and Consultation We have the expertise to assist our esteemed clientele in: Regulatory Affairs Design the IND package for regulatory submission Obtain timely regulatory approval Preparation of Essential Documents Protocol Investigators Brochure Informed Consent Form Patient Information Sheet Case Report Form Logs & Templates Source Document Templates (All documents are designed to conform to ICH GCP and the Indian regulatory guidelines.) Identification of Sites and other support services Identify sites willing to comply with ICH GCP guidelines and the protocol. A site visit is conducted for an in-depth review of the facilities - manpower, infrastructure, IRB status, communication etc. Support service vendor identification, negotiation and finalization Timely translation and back translation of the study documents to the requisite local languages. IRB/EC Approval - Ensure a one time submission and approval. All subsequent amendments are conveyed and favorable approval obtained All safety events are reported within the specified timelines Meticulous documentation maintained Timely reporting on the progress of the trial is done. Commercial and Legal Management Assist in the initial negotiation and finalization Timely and uniform invoicing from multiple sites Prepare site specific clinical trial agreement.

	Conduct and Implementation Pre-trial activities - An in-depth feasibility analysis of the sites capabilities to undertake the clients project is done to- Assess the experience and expertise of the investigator Ensure the adequacy of the manpower Ensure the presence of the requisite infrastructure Ascertain the presence of a functional Institutional Review Board (IRB) / Ethics Committee ( EC) Ensure all pre- trial documentation are collected and filed Ensure all copies of approvals are obtained and filed. Trial Activities - A team of trained Clinical Research Coordinators are at the site with the site team on a day - to - day basis to co-ordinate the trial: Assist in the administration of the Informed Consent Ensure the enrollment of the RIGHT study subjects Schedule the follow up visits Prevent any drop outs or missed visits Ensure timely completion of source documents Completion of the Case Record Forms Co-ordinate monitoring and audit visits Co-ordinate with central laboratory for early dispatch of samples and receipt of reports Timely dissemination of safety reports to all concerned parties Meet the enrollment timelines Periodic updates to the client Periodic training of the site staff

	Completion We ensure : The timely completion of the project Co-ordinate the close out visits Resolve all queries Assist in the proper and safe archival of the essential documents Return of all study related supplies and documents to the client

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