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Clinical excellence
at every step

VitelySMO is a leading site management organization that provides comprehensive and customized services for clinical research in pharmaceuticals, medical devices, CROs, biotechnology and health-related products. We believe in long term partnerships and have a proven track record of delivering high-quality and timely results for our clients, ranging from global pharmaceutical and biotechnology companies to local clinical research sites and contract research organizations. 

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What We Do

Successful clinical trial management involves a harmonious blend of expertise, communication, and meticulous execution. Streamline your clinical trials with our specialized non-medical judgment work, designed to optimize study outcomes.

Clinical Study Acquisition and Management

Facilitate the institution’s participation in relevant clinical studies

  • Identify and evaluate potential studies aligned with institutional goals.
  • Establish collaborations with research sponsors and investigators. 
  • Efficiently manage study contracts, budgets, and timelines.
  • Annual GCP training.
  • Routine site SOP, protocol and manual training.

Expert Staff Provision

Ensure high-quality study execution. 

  • Recruit and deploy skilled study coordinators, auditors, and project managers. 
  • Continuously assess their performance and provide necessary training.

Regulatory and Administrative Support

Streamline study-related processes. 

  • Assist with regulatory submissions (e.g., ethics committees, health authorities).
  • Handle administrative tasks (e.g., approvals, documentation).
  • MOV preparation and execution.
  • Ethics committee approvals and visit management.

Site Coordination and Feasibility

Optimize site readiness.

  • Evaluate site feasibility for study implementation.
  • Collaborate with investigators during site selection and initiation.
  • Monitor progress and ensure timely study closeout.
  • Budget negotiation.

Infrastructure Management

Physical and technological resource management.

  • Procurement
  • Maintenance
  • Calibration

Patient Enrollment and Retention

Enhance patient participation and retention. 

  • Develop patient recruitment strategies..
  • Schedule visits efficiently and maintain patient engagement.
  • Safeguard patient rights and safety throughout the study.
  • Cohort planning to boost the outcome in terms of recruitment and retention of patients.

Data Integrity and Accuracy

Ensure reliable study data.

  • Implement data quality checks and validation processes.
  • Verify completeness, authenticity, and accuracy of collected data.

IEC/Regulatory Compliance

Meet ethical and regulatory standards.

  • Coordinate submissions to institutional review boards (IRBs) and regulatory agencies.
  • Address any compliance-related issues promptly.

Site Development and Preparedness

Ready the site for audits and inspections.

  • Train site staff on study protocols and procedures.
  • Conduct mock audits to identify areas for improvement.

Stakeholder Engagement

Foster collaboration among key players.

  • Interact with external stakeholders (e.g., ethics committees, contract research organizations, laboratories, sponsors).
  • Facilitate effective communication and alignment.

Financial Management

Optimize study budget utilization.

  • Finalize study budgets in consultation with relevant parties (PI and CRO).
  • Regularly raise study invoices as per milestones.

Document Management and IP Maintenance

Organize and safeguard study-related documents.

  • Maintain comprehensive records (e.g., informed consent forms, source documents, etc.). 
  • Ensure proper handling of investigational products (IPs).

PI and Staff Communication

Keep all stakeholders informed. 

  • Regularly update the principal investigator (PI) and site staff.
  • Promote adherence to regulatory requirements and study protocols.

Our Experience

USFDA Inspection

Passed without observations

Trial Setup

Experienced in global phase I-IV trials and BA/BE (early phase trial)


USFDA: 12+ projects, DCGI: 8+ projects, UK-MHRA: 6+ projects

Investigator Initiated Trials

5+ projects

How we do it

We leverage our expertise, experience, and excellence to ensure the success of your clinical trials. We have: 

A team of highly qualified, trained and experienced clinical research coordinators (CRCs) who have extensive knowledge and skills in multiple therapeutic areas.

Our team is well-versed in providing professional assistance to the investigator ensuring compliance with FDA, Local regulations, ICH-GCP, CT Rule 2019, global and domestic guidelines, as well as efficient completion of mandated tasks.

A network of reliable and reputable clinical research sites across India and abroad, who have access to diverse and qualified patient populations and state-of-the-art facilities and equipment.

A system of innovative and efficient implementation methods, tools, and technologies, that enable us to streamline the clinical trial process, reduce errors and risks, and optimize the use of resources and time.

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Why Us

We are committed to providing you with the best, comprehensive set of site management services for your clinical research needs. By choosing us, you will benefit from: 

Strategic Collaborations

  • Strength: Maintain strong relationships with sponsors and pharma companies.
  • Continuous Trials: Consistently attract trials across various indications.
  • Cost-Effective Pricing Models: Offer flexible pricing options to align with your budget and needs. 

Hospital Affiliations

  • Multispecialty Ties: Aligned with both government and private hospitals.
  • Resource Access: Leverage hospital infrastructure and expertise.
  • Enhanced Patient Recruitment and Retention: Streamline processes for higher enrollment and completion rates.

Robust Patient Database

  • Resource Advantage: Possess a vast patient database covering diverse indications.
  • Efficiency Boost: Streamline patient recruitment and retention
  • Improved Data Quality: Ensure accuracy and validity of study results.

Efficiency Measures

  • Investigator Support: Relieve investigator burden.
  • Cost and Time Optimization: Minimize sponsor expenses and study duration.
  • Research Team Focus: Enhance productivity by allowing core competencies and objectives to take center stage.

Clinical Expertise

  • Indication Variety: Extensive experience in various indications, including pharmacokinetic (PK) trials.
  • Quality Assurance: Deploy trained, full-time site-specific clinical research coordinators (CRCs).
  • Predictable Study Timelines: Meet deadlines and milestones efficiently.

Process Standardization

  • SOP Implementation: Establish site-specific standard operating procedures.
  • Timely Documentation: Ensure online, on-time activities and accurate records.
  • Subject Engagement: Proactively follow up with subjects for compliance assessment.

Issue Resolution

  • Field Service Support: Swiftly address front-end challenges.

Therapeutic Areas

General Medicine

General Surgery











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