SMO-INDIA : Clinical Research (L) Pvt Ltd


	Medical Device Study-ALVEOGYL for Post-Extraction Dry Socket: 2024 We are pleased to announce the successful completion of our clinical trial on ALVEOGYL, specifically targeting Post Extraction Dry Socket, conducted across India and France. Our dedicated team was entrusted by the sponsor with comprehensive responsibility for the study, which included: the preparation of the Dossier, Regulatory Submissions, and Approval process for the Investigational Medical Device. The trial was carried out at 14 locations in India and 2 in France, successfully achieving the target of 90 patients within the timeline. We are proud of the progress made and look forward to the next steps in advancing this innovative treatment.


	Oncology-Indolent Non-Hodgkin's Lymphoma SMO-India completed enrollment of 40 patients in a trial for the treatment of CD 20 positive Indolent non-Hodgkin's Lymphoma. Enrollment in the Phase III clinical trial was achieved from 12 clinical sites in India. We were the top recruiting country for this trial: India (40) SMO-India was the collaborator and provided full services, including Regulatory Approvals, Investigator Meetings, Site Selection, Project Management, Monitoring, Drug Depot Management, Import/Export Licenses Liaison, etc. During the time of indeterminate and challenging regulatory circumstances in India, SMO-India was able to get through the submission and approval of this clinical trial well within the targeted timelines.

	Type II Diabetes Mellitus with Chronic Renal Insufficiency This Phase III comparator study for patients with Type II DM with chronic renal insufficiency had poor recruitment with another CRO that started the study earlier in India. Later SMO-India was approached to help with the speed of recruitment. SMO-India identified additional sites and also took over management of CRO-selected sites and was able to exceed the sponsor's initial target of 36 patients by recruiting 45 patients.

	Diabetes Mellitus with Inadequate Glycemic Control SMO-India was asked to assist with recruitment in this trial (managed by another CRO) as enrollment was slower than predicted. SMO-India quickly added 8 more performing sites and achieved the target ahead of schedule. Impressed by our performance, the sponsor extended their other studies to SMO-India in parallel to another CRO. SMO-India recruited 36 patients from 8 sites and stayed ahead of the target throughout the study's duration. The right choice selecting SMO-India by the sponsor for accelerated recruitment later fetched them NDA approval giving them a time advantage over their competitors.

	Diabetes Mellitus with Inadequate Glycemic Control on Insulin SMO-India was contracted to support 40 patients from 7 sites. Due to our prior experience and a preemptive methodology, SMO-India recruited the required number of patients prior to the sponsors' deadline. This study with another CRO was struggling with recruitment with 6 sites in India. In addition to India, this study was being conducted in Australia, Brazil, Columbia, Germany, Israel, Korea, Peru, Philippines, Russia, South Africa, Spain, Taiwan and the USA. This comparative study was later supported by SMO-India in India and helped with the enrollment of 44 patients from an additional 6 sites.


	Our Vision

	Our vision is to charter new frontiers of medical and pharmaceutical science and technology by excelling in providing true-blue professional services in the realm of Clinical research.

	Our Mission

	Our mission is to establish ourselves as India's trail-blazer Contract Research Organization by weaving a network of highly qualified and experienced clinical researchers and healthcare professionals with demonstrated expertise in conducting clinical trials and to maintain the highest standards of quality, time-sensitivity, unwavering commitment to excellence, and uncompromising compliance with the statutory regulations in initiating, conducting, controlling and comprehensively managing the Clinical operations.

	Core Values

	We ensure research subjects are fully apprised of all the risks & benefits arising in and out of the study. We strictly adhere to the principles governing the privacy and confidentiality of the research subjects. Care and caution are our watch words at all stages of the research to ensure that the research subject is not put to undue risk. We ensure the research is conducted only by competent and qualified persons who act with total integrity and impartiality. We conduct the research in a fair, honest, objective and transparent manner after full disclosures are made of each aspect of their interest in the research by all those associated with the study. We strictly observe principles of compliance. We provide services in a most cost-effective manner without compromising on quality.


	Our Expertise

	SMO India has exceptionally qualified staff of about 40 with a clinical trial experience in managing Phase trials in broad spectrum of therapeutic areas. We have the scientific and clinical expertise to take a trial from concept to completion, as well as combining all of the functional areas of a CRO to conduct Phase II, Phase III and Phase IV clinical trials. Our experience gained through global exposure to clinical studies allows us to understand clinical study requisites and objectives. This knowledge and experience enable us to guide clients to formalize an optimal development plan and strategy that will shorten trial time and produce uncompromised data and results. We have access to highly skilled sites and provide site specific guidance and support. The highly motivated team supports upbeat Ethics Committee management, patient recruitment and patient retention. Thus, enabling the investigators to dedicate time to focus on the patients, and ensure that the study is conducted in the highest standards of quality, ethics and performance. This support ensures collection of high quality study data necessary for regulatory and product approval submissions. SMO India is an assurance for in-depth pre-study planning, most appropriate and nearly accurate feasibility data, most favorable patient recruitment rate, transparency in communication between sites and all parties involved. We have successfully completed 14+ Clinical trials as a full-service Contract Research Organization (CRO). 115+ Clinical trials as Site Management Organization (SMO). 50+ exclusive and associated sites across India End-to-end Multinational and Multi-centric (FDA-approved) Investigational Product Studies for many Sponsor companies which have been successfully commercialized.


	Our Expertise

	SMO-India’s exceptionally qualified staff have over 25 years of domain clinical trial experience in managing over 70 trials in a broad spectrum of therapeutic areas. We have the ability to guide our clients from initial trial planning stages to regulatory submissions phase. Our experience gained through global exposure to clinical studies allows us to understand clinical study requisites and objectives. This knowledge and experience enable us to guide clients to formalize an optimal development plan and strategy that will shorten trial time and produce uncompromised data and results.