SMO-INDIA : Clinical Research (L) Pvt Ltd



	Phase II and III Clinical trails : "SMO-India outshone by selectiong sites with dedicated, experienced investigators and the appropiate patient population. Phase IV/ Post Marketing : SMO-India will support your needs and meet your research objectives by providing customized strategic and scientific solutions to move from product development to commercialization in a cost-effective and unified approach.

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CRO/Sponsor

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	For CRO / Sponsor

	SMO-India provides services in all related spheres to support our clients’ Clinical trial processes. The services are customized to our clients’ requirements. We look to enable our clients to perform to their best potential. We help them to streamline their activities and extend their geographic coverage in order to capitalize on their products as swiftly and effectively as possible in the marketplace. We achieve this through our:
	Network of experienced physicians and coordinators across India, which is continuously expanding. Excellence in Onsite Coordination and Monitoring of Phase II, III, and IV clinical trials. Leadership and management expertise necessary to produce consistent and statistically sound data for every study conducted. Multiple Therapeutic Segments. Streamlined and expeditious start-up and completion of studies on schedule. Large and diverse patient population with a positive attitude towards clinical research. Dedicated full time certified Clinical Research Coordinators experienced in working with Pharmaceutical companies and Contract Research Organizations. Quality source documentation, case report forms and other paperwork. Sites that are top enrollers nationwide on multiple studies by virtue of their inherent merits. "Centralized organizational Structure" offers Sponsor and CRO clients immediate access to several pre-qualified investigators in all therapeutic segments To improve current standards as well as the overall standards of Clinical Research, we are constantly developing a clinical trial database at the site level as well as central level at headquarters. This serves as a quick, efficient and effective tool to deliver accurate, precise feasibility analysis. Thus SMO- India is becoming reliable partner for Sponsor/CRO in conducting multicentric clinical trials. This also helps to efficiently organize the total clinical trial process, both centrally (HQ) and locally (Site). Our organizational structure" offers Sponsor and other clients immediate access to several pre-qualified investigators in all therapeutic segments. SMO-India offers the below mentioned services to cater our client's clinical trial requirements: Feasibility, Site Selection & Onsite Trial Management Project Management and Monitoring for Phase clinical trials Patient recruitment & Retention strategies Regulatory support Clinical trial staff support

	Feasibility . Efficient site selection after a reliable feasibility data analysis . Short turnaround time with feasibilities . "Organizational Structure" offers Sponsor and CRO clients immediate access to several pre-qualified investigators in all therapeutic segments.
	Site Selection . Efficient short listing of prospective Investigators from our database . Work with sites for Pre-initiation and prepare them for trial related activities . Evaluation of sites based on the patient pool, investigator's area of expertise and connectivity to the site. . Network of the top enrolling sites nationwide on multiple studies by virtue of their inherent merits . Sites well equipped with infrastructure and logistics required for clinical trials
	Trial Management . Pre study set up of the site . Clinical Trial Agreements as per projected study budget and review . Infrastructure provisioning . Procuring pre-study essential documents . Conduct of Investigators' Meetings . IEC/IRB submissions and follow up for timely acknowledgements and approvals . Documentation procedures, such as Trial Master File Management, Central Investigator File and Investigator Site File . Training on IP handling, lab sample handling procedures, ECG, etc. . Efficient coordination of the logistics . On-site developmental briefing of Investigator and the research team . Streamlined and expeditious start-up and completion of studies on schedule . Maintenance of CRFs, Informed Consent Forms (ICF) and study logs . Timely resolution of queries which help the sites to generate clean & legible data . Drug accountability, preparation and dispensing as per the study protocol requirements. . Excellence in on site coordination and monitoring of Phase II, III, and IV clinical trials . Database at site as well as centrally (at headquarters), serves as a quick, efficient and effective tool to deliver accurate, precise feasibility analysis
	Patient Recruitment & Retention Strategies . Strategic planning of recruitment based on protocol requirement . Assisting sites in organizing health camps . Patient referrals through peripheral centers from tier II & tier III cities . Patient retention programs . Patient reminder calls & letters . Physician referral letters . Advertisements when applicable.
	Regulatory support As per the Indian Regulatory requirements SMO India supports following activities: . Preparation and compilation of the Clinical Trial Application for permission to conduct clinical trials. . Obtain import/export licenses for Clinical Trial Materials & lab Samples . Handling of all Customs related issues . Post regulatory approval compliance and submission of subsequent study document amendments
	Staff support As Per the recent survey of Center watch, more than 50% of the delays in Phase II & Phase III trials are caused by poor patient recruitment. In addition to this 80% of clinical trials experienced enrollment delays. As of now investigators are mainly responsible for patient recruitment. The key to success is to improve the efficiency of Clinical trial process at the site level by providing well qualified, trained and experienced Clinical Research Associate (CRA) with trial management as well as quality compliance team support, which SMO-India achieves through. SMO India implements an aggressive and a due diligence process for patient recruitment program to support the sites endeavors. We strive through stable and effective working relationships with clinical sites. • Dedicated full time qualified Clinical Research Associates experienced in working with Pharmaceutical companies and Contract Research Organizations. • ICH-GCP trained staff ensures that the clinical data generated is credible A well trained CRC placed by us assists site and the PI in: • An appropriate execution of protocol • Follow up and query resolution and thus save our clients' precious time. • Assist in Ethics committee submissions & follow up. • Coordinate logistics management at sites. • Real time communication by the CRC with head office brings in the connectivity with the site.


	For Investigator / Sites

	SMO-India coordinates with you to organize, conduct and complete successful clinical trials. Our services include:

	1. Trial Management

		1.1 Study Design and Protocol Development Complete literature review and meta-analysis Statistical planning (sample size estimation, randomization, and power calculations) Case Report Form (CRF) design and guidelines to fill-in Informed consent form (ICF) 1.2 Pre-study Site Preparation Site feasibility studies Site selection and evaluation Collection of essential documents Investigators’ meetings Documentation procedures, such as Trial Master File Management, central investigator file and investigator site file Investigator Grants Management 1.3 Site Initiation and Training Staffing with trained and experienced CRCs Patient recruitment support Investigational Product (IP) Management Training on IP, lab handling procedures, ECG, etc. Logistics management Site specific Standard Operating Procedures (SOP's) On-site developmental briefing of Investigators and research team Customized Programs in: - Working and interacting with Regulatory Authorities. - Effective informed consent processes for subjects - Regulatory document preparation and maintenance - Current industry standards (GCP, GLP Maintenance of CRFs, Informed Consent Forms (ICF) and study logs Drug accountability and central laboratory Interactive Voice Response System (IVRS) and ECG procedures Preparation for audits Business Development of the Site and its capabilities Notification of upcoming research trials and opportunities Provide expertise in customized budget preparation Ethics committee approval, DCGI clearance 1.4 Site Monitoring Patient follow up Tracking CRFs Regulatory compliance Site Quality Assurance Maintenance of Site documents Resolution of queries Research site liaison Progress and status reports Resolution of issues like Serious Adverse Event and DCFs within timelines 1.5 Study close out Patient follow up Tracking CRFs Regulatory compliance Site Quality Assurance Maintenance of Site documents Resolution of queries Research site liaison Progress and status reports Resolution of issues like Serious Adverse Event and DCFs within timelines

	2. Data Management
	Precise and accurate data entry method, data validation, data analysis, data resolution and storage. Maintaining of accuracy, integrity and confidentiality at every stage of the clinical trial. Supporting EDC.
	3. Regulatory Support
	Facilitate ethics committee approval, DCGI clearance. Site support for Pre- and Post-Regulatory inspection. Obtaining import and export licenses for new molecules/products.