Site management organization

Last updated February 22, 2019

A Site Management Organization (SMO) is an organization that provides clinical trial related services to a contract research organization (CRO), a pharmaceutical company, a biotechnology company, a medical device company or a clinical site. The site is usually a hospital or a similar health care institution that has adequate infrastructure and staff to meet the requirements of the clinical trial protocol. The scope of an SMO's responsibility is limited to the 'site' and hence the eponymous title. Some (but not all) of the responsibilities include:

Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial – their approval does not mean that the therapy is 'safe' or effective, only that the trial may be conducted.

A contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, clinical trials management, and pharmacovigilance. CROs are designed to reduce costs for companies developing new medicines and drugs in niche markets. They aim to simplify entry into drug markets, and simplify development, as the need for large pharmaceutical companies to do everything ‘in house’ is now redundant. CROs also support foundations, research institutions, and universities, in addition to governmental organizations.

Biotechnology Use of living systems and organisms to develop or make useful products

Biotechnology is the broad area of biology involving living systems and organisms to develop or make products, or "any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use". Depending on the tools and applications, it often overlaps with the (related) fields of molecular biology, bio-engineering, biomedical engineering, biomanufacturing, molecular engineering, etc.

Contract
Submission for Institutional Review Board or Independent Ethics Committee (IRB/IEC) approval. In Europe, submission to Ethics Committee is often done by sponsor or by CRO, i.e. not by SMO
Patient Counseling
Patient Recruitment
Patient Follow-up
Informed consent form (ICF) translation into vernacular languages^{[ dubious – discuss ]} . In Europe, this is often done by the Sponsor or CRO
Site initiation and trial close-out operations
Trial-related documents archival and maintenance
Reporting serious adverse events to the Sponsor or CRO and the IRB/IEC
Ensuring protocol compliance
Advising & alerting investigators of potential protocol violations
Advising & alerting investigators of potential ICH-GCP violations

Informed consent is a process for getting permission before conducting a healthcare intervention on a person, or for disclosing personal information. A health care provider may ask a patient to consent to receive therapy before providing it, or a clinical researcher may ask a research participant before enrolling that person into a clinical trial. Informed consent is collected according to guidelines from the fields of medical ethics and research ethics.

A serious adverse event (SAE) in human drug trials is defined as any untoward medical occurrence that at any dose

results in death,
is life-threatening
requires inpatient hospitalization or causes prolongation of existing hospitalization
results in persistent or significant disability/incapacity,
may have caused a congenital anomaly/birth defect, or
requires intervention to prevent permanent impairment or damage.

Origin

SMOs are relatively new entrants into the field of clinical research and have since grown at an explosive rate in the U.S. and other countries like India, China and Brazil where clinical trial outsourcing has been at its peak. The fledgling SMO industry is currently valued at about $3 billion and is expected to grow further according to recent estimates from R&D Directions - a market research firm.

Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment.

Market research is an organized effort to gather information about target markets or customers. It is a very important component of business strategy. The term is commonly interchanged with marketing research; however, expert practitioners may wish to draw a distinction, in that marketing research is concerned specifically about marketing processes, while market research is concerned specifically with markets.

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Human subject research is systematic, scientific investigation that can be either interventional or observational and involves human beings as research subjects. Human subject research can be either medical (clinical) research or non-medical research. Systematic investigation incorporates both the collection and analysis of data in order to answer a specific question. Medical human subject research often involves analysis of biological specimens, epidemiological and behavioral studies and medical chart review studies. On the other hand, human subject research in the social sciences often involves surveys which consist of questions to a particular group of people. Survey methodology includes questionnaires, interviews, and focus groups.

An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a type of committee that applies research ethics by reviewing the methods proposed for research to ensure that they are ethical. Such boards are formally designated to approve, monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be conducted. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. Along with developed countries, many developing countries have established national, regional or local Institutional Review Boards in order to safeguard ethical conduct of research concerning both national and international norms, regulations or codes.

Clinical monitoring is the oversight and administrative efforts that monitor a participant's health and efficacy of the treatment during a clinical trial. Both independent and government-run grant-funding agencies, such as the National Institutes of Health (NIH) and the World Health Organization (WHO), require data and safety monitoring protocols for Phase I and II clinical trials conforming to their standards.

Safety monitoring of a clinical trial is conducted by an independent physician with relevant expertise. This is accomplished by review of adverse event, immediately after they occur, with timely follow-up through resolution.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

An academic clinical trials is a clinical trial not funded by pharmaceutical or biotechnology company for commercial ends but by public-good agencies to advance medicine. These trials are a valuable component of the health care system; they benefit patients and help determine the safety and efficacy of drugs and devices, and play an important role in the checks and balances that regular commercially oriented clinical trials.

Good clinical practice (GCP) is an international quality standard that is provided by ICH, an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects. A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.

A data clarification form (DCF) or data query form is a questionnaire specifically used in clinical research. The DCF is the primary data clarification tool from the trial sponsor or contract research organization (CRO) towards the investigator to clarify discrepancies and ask the investigator for clarification. The DCF is part of the data validation process in a clinical trial.

The ethics committee, according to Directive 2001/20/EC, is an independent body in a member state of the European Union, consisting of healthcare professionals and non-medical members, whose responsibility is to protect the rights, safety and well being of human subjects involved in a clinical trial and to provide public assurance of that protection, by, among other things, expressing an opinion on the clinical trial protocol, the suitability of the investigators involved in the trial and the adequacy of facilities, and on the methods and documents to be used to inform trial subjects and obtain their informed consent.

A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of a Principal Investigator (PI).

In health care, a clinical trial is a comparison test of a medication or other medical treatment, versus a placebo, other medications or devices, or the standard medical treatment for a patient's condition.

The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that deals with ethical oversights in clinical research conducted by the Department, mostly through the National Institutes of Health (NIH).

A glossary of terms used in clinical research.

Patient recruitment includes a variety of services—typically performed by a Patient Recruitment Service Provider—to increase enrollment into clinical trials. Presently, the patient recruitment industry is claimed to total $19 billion per year.

A clinical trial portal is a web portal or enterprise portal that primarily serves sponsors and investigators in a clinical trial. Clinical portals can be developed for a particular study, however study-specific portals may be part of larger, clinical sponsor or Contract Research Organization (CRO) portals that cover multiple trials. A clinical portal is typically developed by a sponsor or CRO to facilitate centralized access to relevant information, documentation and online applications by investigational sites participating in a trial, as well as for the monitors, study managers, data managers, medical, safety and regulatory staff that help plan, conduct, manage and review the trial.

The term informed assent describes the process whereby minors may agree to participate in clinical trials. It is similar to the process of informed consent in adults, however there remains some overlap between the terms.

ViS Research is an American multinational company that optimizes clinical trial planning through a structured, online feasibility platform. The platform provides tools and analytics to pharmaceutical and biotechnology companies and contract research organizations that transform how locations, research centers and investigators are evaluated for inclusion in clinical trials.