Industry

WHY AN SMO?

Site Management Organizations (SMO) provide clinical trial service activities that are dedicated to running and managing the clinical site for a larger CRO (clinical research organization) or sponsors. With their team of experienced professionals they help alleviate the pain of managing a site for both the physician and the sponsor/CRO.

Clinical guidelines that govern treatment of patients in any health care institution originate from successful conduct of clinical research which involves the study of novel drugs or procedures towards resolving a health related problem

[1]. Clinical trials that form the heart of clinical research are essential to test the efficacy and safety of various experimental drugs and medical devices in humans. Clinical trials for a drug or a device are conducted over months to years on 10s to 100s of volunteers that take part to benefit themselves or society as a whole.

There are different types of clinical trials, including:

  • i) natural history trials that involve studying the progression and history of diseases
  • ii) Prevention trials that look at better and safer ways to prevent the development or spread of diseases in people,
  • iii) Screening trials to detect the best way to screen a disease or medical condition

[2]. All clinical trials involve a sponsor who might be an individual or an industry, or organization that owns the drug or device and the physician that has the medical qualification to conduct the trial at an approved healthcare facility called the clinical research site. Managing a site requires experience and acquired knowledge of Good clinical practices (GCP) that describes and regulates the responsibilities and obligations of sponsors, investigators and clinical site personnel.

SMOs are individuals or organizations that are retained as an independent contractor to the principal investigator (PI) or clinical research site to provide comprehensive administrative support to the site. This support include but is not limited to site setup and initiation, patient recruitment and retention, compliance and regulatory monitoring of the site, personnel recruitment and training, contract and budget negotiations on behalf of the research site and document archival and maintenance . The SMOs might also perform other functions as necessary to support and develop the clinical site. While the more common Clinical Research Organizations (CRO) are the agents of the sponsor, the SMO is usually the agent of the physician or the principal investigator.The CRO industry is a $16 billion dollar industry with an annual growth over the past 5 years of 10.9% and expected to increase by 9% over the next 5 years[1]. Nearly 41% of that industry is consigned to clinical trials. Sometimes, CROs do perform the function of an SMO as well and negotiate with the PI directly to help run the site. Similarly, sometimes SMOs behave like CROs and directly enter into negotiations with the sponsor on behalf of the PI. The Buffalo-Niagara Clinical Alliance, LLC is an SMO with primary functions as outlined in Figure 2. The BNCA will contract with physicians in and around the Buffalo-Niagara regions, help them identify potential sponsors, negotiate budgets and contracts and help the research site run their day to day operations.

  • iv) Diagnostic trials to develop better tools and techniques to diagnose a medical condition
  • v) Treatment trials, which are the most common type that test the efficacy of new drugs or combinations and medical devices to different therapies and
  • vi) Quality of life trials, that help investigate different ways to improve quality of life or reduce pain and suffering in patients with specific illnesses

[3]. All clinical trials involve a sponsor who might be an individual or an industry, or organization that owns the drug or device and the physician that has the medical qualification to conduct the trial at an approved healthcare facility called the clinical research site. Managing a site requires experience and acquired knowledge of Good clinical practices (GCP) that describes and regulates the responsibilities and obligations of sponsors, investigators and clinical site personnel.

SMOs are individuals or organizations that are retained as an independent contractor to the principal investigator (PI) or clinical research site to provide comprehensive administrative support to the site. This support include but is not limited to site setup and initiation, patient recruitment and retention, compliance and regulatory monitoring of the site, personnel recruitment and training, contract and budget negotiations on behalf of the research site and document archival and maintenance . The SMOs might also perform other functions as necessary to support and develop the clinical site. While the more common Clinical Research Organizations (CRO) are the agents of the sponsor, the SMO is usually the agent of the physician or the principal investigator.The CRO industry is a $16 billion dollar industry with an annual growth over the past 5 years of 10.9% and expected to increase by 9% over the next 5 years[1]. Nearly 41% of that industry is consigned to clinical trials. Sometimes, CROs do perform the function of an SMO as well and negotiate with the PI directly to help run the site. Similarly, sometimes SMOs behave like CROs and directly enter into negotiations with the sponsor on behalf of the PI. The Buffalo-Niagara Clinical Alliance, LLC is an SMO with primary functions as outlined in Figure above. The BNCA will contract with physicians in and around the Buffalo-Niagara regions, help them identify potential sponsors, negotiate budgets and contracts and help the research site run their day to day operations.

  • [1].Contract Research Organizations in the US.IBISWorld. 2014.
  • [2]. NIH clinical trials and you: The basics. National Institutes of Health. 2012. http://www.nih.gov/health/clinicaltrials/basics.htm
  • [3]. NIH clinical trials and you: http://www.nih.gov/health/clinicaltrials/basics.htm#2.
  • [4]. Keys to building a successful research site. Duke Clinical Research Institute. Dec. 2003.