smo-site-management-organization-cover-photo

What is a SMO?


A site management organization (SMO) is an organization that provides services to the investigator at a clinical site. SMOs can perform all the work involved in clinical trial at the site.

SMO Services

Site Management Organizations (SMOs) provide a many of the necessary services needed to facilitate a successful clinical trial. The goal of the services offered by a SMO is to streamline the clinical trial process, improve data quality, and to make sure the clinical trial is in compliance with regulatory standards.

SMO services are geared towards helping pharmaceutical, biotech, and medical device companies easily and seamlessly navigate the complexity of a clinical trial. Here are some typical services offered by SMOs:

  • Site Identification and Setup
    SMOs help identify and set up clinical trial sites that meet the necessary requirements for the study, including infrastructure and personnel qualifications.
  • Patient Recruitment and Retention
    They develop strategies to recruit and retain suitable trial participants to meet enrollment targets quickly and maintain patient engagement throughout the study.
  • Regulatory Compliance
    SMOs manage and oversee all regulatory compliance issues related to the trial, including obtaining necessary approvals from regulatory bodies and ensuring that the trial follows local, national, and international guidelines.
  • Training and Support
    Providing training for site staff on clinical trial protocols, data collection methods, and the use of any specific technology or software required for the trial. This ensures all processes are standardized and errors are minimized.
  • Data Management
    This includes collecting, storing, and managing trial data to ensure its accuracy, integrity, and confidentiality. Effective data management also involves setting up electronic data capture (EDC) systems and ensuring proper data validation.
  • Monitoring
    SMOs conduct regular monitoring visits to sites to ensure the trial is conducted according to the protocol, to verify data accuracy, and to address any issues that arise during the trial’s execution.
  • Quality Assurance
    Implementing quality control processes to ensure that all aspects of the trial are conducted in compliance with the highest standards, from adherence to protocols to the ethical treatment of participants.
  • Financial Management
    Managing the budget of the clinical trial, including payments to trial sites and other financial transactions related to the conduct of the trial.
  • Logistics Coordination
    Handling the logistics of the trial, such as the distribution of trial materials and supplies, including investigational drugs, to various sites.
  • Reporting
    Generating reports for stakeholders that provide insights into the trial’s progress, preliminary results, and compliance status.

Similar to CROs, services at SMOs are done through a contractual agreement. Although the services are outsourced, the investigator at the site is still the responsible party who needs to oversee and audit the quality of any work done by the SMO.

Benefits & Risks of Using a SMO

Potential benefits of outsourcing to SMOs include:

  • Reduction of time and resources needed to conduct a clinical trial.
  • Lower initial investment and on-going costs in hiring personnel, equipment, and facilities needed.
  • Expanded pool of access to expertise.
  • Access to standardized processes of clinical trial conduct.
  • Better data collection and management.

Potential risks of outsourcing to SMOs include:

  • Reduced control in direct management of clinical trial conduct.
  • Potential budget overruns due to unexpected delays.
  • Consistency from project to project may vary depending on personnel turnover at SMOs.

Growing Trend in Outsourcing Work to SMOs

Similar to the growing trend for CROs, the industry trend is heading toward the outsourcing model. Investigators are outsourcing more and more of the work out to SMOs. Large CROs are expanding the scope of work to offer SMO services. Yet there is room to grow for smaller SMOs in different regions of the world. The trend for outsourcing of clinical trial related work remains strong for the foreseeable future.

List of SMOs

United States

  1. Pharmaceutical Product Development, LLC (PPD) – PPD Website
    PPD offers a broad range of clinical trial management services, specializing in drug development, laboratory services, and lifecycle management. Their global operations support biotech, pharmaceutical, and medical device companies.
  2. IQVIAIQVIA Website
    IQVIA combines advanced analytics, technology, and expertise to drive healthcare forward, specializing in data science and clinical trials to improve patient outcomes.
  3. CovanceCovance Website
    As a part of LabCorp, Covance provides comprehensive drug development services and harnesses robust diagnostics expertise, making it a leader in both the CRO and diagnostics industries.
  4. PRA Health SciencesPRA Health Sciences Website
    PRA Health Sciences focuses on innovative drug development and clinical trial management, offering patient-centric solutions to accelerate outcomes in the healthcare sector.
  5. Syneos HealthSyneos Health Website
    Syneos Health offers a unique fully integrated end-to-end service model, merging clinical and commercial insights to enhance the speed and effectiveness of drug development processes.
  6. ICON plcICON plc Website
    Specializing in pharmaceutical, biotechnology, and medical device trials, ICON plc offers both local and global expertise in clinical development and functional services.
  7. MedpaceMedpace Website
    Medpace is distinguished by its physician-led, therapeutic-focused approach that supports drug development from its foundational stages through to clinical trials.
  8. PMG ResearchAccellacare Website
    PMG Research is an integrated network of clinical research facilities known for accelerating new medical therapies through a patient-centered approach that enhances engagement and efficiency across multiple therapeutic areas. They recently merged with Accellacare.
  9. Remington Davis Clinical ResearchRemington Davis Website
    Based in Columbus, Ohio, Remington-Davis Clinical Research conducts high-quality clinical trials across various medical disciplines, focusing on meticulous patient care and precise data collection.
  10. SyreonSyreon Website
    Syreon specializes in clinical trials for complex diseases using advanced analytical models and big data to optimize outcomes and drive healthcare innovation.

Canada

  1. Cetero Research
    Formerly a key player in early clinical research and bioanalysis, Cetero Research was known for its efficient clinical trial management before its absorption by a larger entity.
  2. KGK ScienceKGK Science Website
    KGK Science offers contract research services with a focus on the health products sector, integrating clinical trials with regulatory expertise to support claims substantiation and product development.
  3. LMC Manna ResearchLMC Manna Research Website
    As Canada’s largest network of clinical research sites, LMC Manna Research specializes in metabolic diseases and tailored clinical trial management, enhancing diabetes and endocrine research.
  4. Pharm-OlamPharm-Olam Website
    Pharm-Olam supports full-service clinical trial needs from phase I to IV, focusing on infectious diseases, oncology, and rare diseases with a strong presence in emerging markets.
  5. AltasciencesAltasciences Website
    Altasciences is a forward-thinking CRO that provides early phase drug development services, with a focus on streamlining the process from preclinical stages through to proof of concept.
  6. NutrasourceNutrasource Website
    Nutrasource blends regulatory consulting with clinical trial management, specializing in nutraceuticals, dietary supplements, and functional foods to navigate complex regulatory environments.

Author

Post author

Ernie Sakchalathorn

Polachai Ernie Sakchalathorn is the founder of ClinicalResearchAssociateCRA.com and has been in clinical research since 2007. While he is no longer affiliated with the website or benefits financially from site operations, he still remains a professional in the clinical research space and currently serves as a Clinical Affairs Manager at a medical device company.

Leave a Reply

Your email address will not be published. Required fields are marked *