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  Training & Education  
  SMO - India is committed to accomplishing talent, providing progressive opportunities, and imparting professional development programs in the industry.
Our standard training sessions include the latest regulation updates, therapeutic area trainings, protocol specific trainings, electronic data capture, quality assurance, site evaluation, monitoring visits, CRF review, investigator meetings, and much more.
The hard work and accomplishments is recognized and rewarded to the most dedicated employee by promoting from within our ranks.
Additionally, towards the personality development of our employees, we offer development beyond technical training, in areas such as communication skills, project management, and leadership.
The senior and experienced clinical staffs serve as mentors and coaches to support career development by evaluating skill sets and recommending options for the acquisition of new skills.

 
  Careers @ SMO  
  To achieve our vision, we are always looking out for talented and ambitious individuals who are willing to learn, accept challenges and have a passion to excel! Each of our employees is an important factor in generating a cohesive force, which ultimately takes us to our Goal.  
     
  Current Job Openings  
   
  You can post your updated resume with clinical research experience to info@smo-india.com  
     
     
     
  Experience and Testimonials  
   
1. Phase II and Phase III studies:  
  To take a pharma product to the next stage, SMO-India is experienced to provide a detailed Feasibility Study, Regulatory support, and complete study conduct. We have effectively provided turn-key solutions for unique requirements of the sponsors, which enabled us to work together commendably. SMO-India has supported various organizations with their development programs through our full-service solutions.

When establishing safety and efficacy is the primary goal, SMO-India has assisted sponsors through monitoring safety, demonstrating effectiveness, and the evaluation of benefit-risk ratio. Our experienced team has efficiently supported clinical trials 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 outshone by selecting sites with dedicated, experienced investigators and the appropriate patient population,
     
2. Phase IV / Post-Marketing studies:  
  At this vital phase of clinical research, SMO-India has been an experienced strategic partner, and have supported sponsor's needs and met their research objectives whether monitoring safety, demonstrating effectiveness, evaluating benefit-risk to gain market access, or proving efficacy by providing customized strategic and scientific solutions in a cost-effective and unified approach.

SMO-India's capability in this vital phase includes:

 
  1. Retrospective data collection
2. Health outcomes/economics
3. Effectiveness comparatives
4. Safety outcomes
5. Patient-reported outcomes
6. Patient registry studies
 
     
3. Rescue Studies :  
  The complexity of clinical trials and the pressures of meeting deadlines can lead to the need for supplemental or replacement assistance. SMO-India was able to seamlessly work alongside other CROs using its 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 sites network and centralized operations model allowed SMO-India to quickly initiate sites. Your need for additional sites in an active study, sites in new study or want to allocate an ongoing study, SMO-India can accomplish your enrollment targets while bringing quality data. Our team will quickly analyze the options for enrollment. After assessment, the project plan is initiated and a parallel team works towards achieving the regulatory approval, site agreements and logistical requirements for the study.  
     
4. Biosimilars 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 biosimilarity (how similar is "similar"), extrapolation, and immunogenicity. SMO-India offers a complete solution for the clinical trial conduct of Biosimilars, and expertly manage the operational aspects of these trials.  
     
5. Ayurvedic / Herbal products Studies:  
  SMO-India has experience in conducting ayurvedic / herbal consumer products clinical trials and meeting the objective of the study within the targeted timelines, subjects' recruitment and retention and timely completion of the clinical study.  
     
6. Global Clinical Trials: Our Accomplishments  
     
  a) Oncology Indolent Non-Hodgkin's Lymphoma  
  SMO-India completed enrollment of a 40 patients in a trial for the treatment of CD 20 positive Indolent non-Hodgkin's Lymphoma. Enrollment of the Phase III clinical trial was achieved in six months (ahead of schedule) from12 clinical sites in India.
First-Patient-In was on time Last-Patient-In was on time Regulatory and EC approvals were ahead of set timelines
Top recruiting countries: India (40), Russia (38) Ukraine (14)
We recruited 40 patients from 12 sites in 6months

SMO-India were the collaborators and provided full services including regulatory approvals, Investigator meeting, site selection, project management, monitoring, drug depot management, Import/Export licenses liasoning 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.
 
     
  b) 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 the India. Later SMO-India was approached to help with the speed of recruitment.
SMO-India recommended 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 in 3months. SMO-India recruited over half of the 90 required patients with their exclusive sites and the sites provided by the CRO, in less time.
 
     
  c) 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 set up 8 sites and achieved the target a few weeks 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 8sites in 9weeks 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.
 
     
  d) Diabetes Mellitus with Inadequate Glycemic Control on Insulin  
  SMO-India was contracted to support 40 patients from 7 sites in 10 weeks. Due to our prior experience and a preemptive methodology, SMO-India recruited the required number of patients one week prior to the sponsors' deadline.  
     
  e) Diabetes Mellitus with Renal Impairment  
  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 enrollment 44 patients in 6weeks from 6sites.
Services provided were patient recruitment retention and site management.