• Network of experienced physicians and coordinators across India, which is continuously expanding.
• Excellence in Onsite Coordination and Monitoring of Phase I, 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
• Clinical Quality Assurance
• Regulatory Support
• Ethics Committee Services
• Clinical trial staff support
• Data Management at Site
• Training & Education

  1.1 Study Design and Protocol Development

  1.2 Pre-study Site Preparation

  1.3 Site Initiation and Training

  1.4 Site Monitoring

  1.5 Study close out

• 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 Electronic Data Capture (EDC).

• Facilitate Ethics Committee approval, DCGI clearance.
• Site support for Pre and Post-Regulatory Inspection.
• Obtaining Import and export licenses for new molecules/products.

• Our standard training sessions include the latest regulation updates, therapeutic area training, protocol-specific training, Quality Assurance, Site evaluation, Monitoring visits, CRF review, Investigator Meetings, and much more.
• Site support for Pre- and Post-Regulatory inspection.
• 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 staff serve as mentors and coaches to support career development by evaluating skill sets and recommending options for the acquisition of new skills.

• SMO India' Regulatory Affairs Third Party Review Unit is dedicated to supporting medical device manufacturers targeting U.S. market access. We are in the process of aligning with FDA' 510(k) Third Party Review (3P510k) pathway to deliver compliant, high-quality regulatory reviews for Class I and eligible Class II medical devices.



• Our Services
  
  
  • Third Party Review of eligible medical devices under 510(k) program
  • 510(k) submission consulting & file preparation
  • Mock 510(k) technical file reviews
  • FDA-aligned risk assessments & traceability matrix support
  • ISO 13485 QMS compliance advisory