| Phase I, Phase II, and Phase III With your product now showing promise, you have entered a critical stage of your therapy's future success. SMO-India has supported various organizations with their development programs through our full-service solutions. To enable you to take your product to the next stage, we can provide a detailed Feasibility Study, Regulatory, Translations, etc. SMO-India provides turn-key solutions to your unique requirements, which enables us to work together to create a healthier world. |
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| When your new product is meeting its key objectives. Establishing safety and efficacy is the primary goal. SMO-India can assist by monitoring safety, demonstrating effectiveness, and the evaluation of benefit-risk ratio. Our solutions are a perfect match for your program's unique needs, and our experienced team is available to support your program at any time, at any stage - starting at protocol development through final submission and post-marketing. Thereby, we become the preferred partners for many sponsors / CROs. | ||
| "SMO-India outshines by selecting sites with dedicated, experienced investigators and the appropriate patient population, | ||
| Phase IV / Post-Marketing This is crucial for the success of your product. SMO-India serves as an experienced strategic partner, supporting your research objectives such as monitoring safety, demonstrating effectiveness, and evaluating benefit-risk for market access.
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| Rescue Studies SMO-India has been contacted with increasing frequency when problems arise during ongoing studies. The complexity of clinical trials and the pressures of meeting deadlines can lead to the need for supplemental or replacement assistance. We are able to seamlessly work alongside other CROs using our established processes to ensure smooth integration with sponsors and/or other vendors. Our corporate structure promotes flexibility, and our working practices can be far more efficient and effective than larger organizations. Our site's network and centralized operations model allow SMO-India to quickly initiate sites. On your requirement for additional sites in an active study or sites in a new study, SMO-India can accomplish your enrollment targets while bringing quality data. Our team will quickly analyse the requirements for enrollment. After assessment, the project plan is initiated, and a parallel team will work towards achieving the regulatory approval, site agreements, and logistical requirements for the study. |
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| Biosimilar Studies Interest in Biosimilar drug development has increased dramatically, particularly driven by the promise of reductions in the cost of treatments, particularly with recent biosimilar drug approvals by the international and Indian regulatory agencies. To move a program forward successfully, several critical questions have to be answered, including a complete analysis of bio-similarity (how similar is "similar"), extrapolation, and immunogenicity. SMO-India offers a complete solution for the clinical trial conduct of Biosimilars and expertly manages the operational aspects of these trials. |
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| Ayurvedic / Herbal Product Studies SMO-India has experience in conducting ayurvedic/herbal consumer products clinical trials and meeting the objective of the study within the targeted timelines, subject recruitment and retention, and timely completion of the clinical study. |
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| Audit & Inspection We take pride in our proven track record of successfully navigating regulatory inspections and sponsor audits across multiple clinical studies. Our commitment to compliance, data integrity, and patient safety is reflected in the outcomes of these evaluations.
Key Highlights: |
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| Our Vision | ||
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| 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 | ||
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| 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 | ||
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| Our Expertise | ||
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| 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.
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| Our Expertise | ||
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| 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. | ||