Site Management Organizations come in different shapes, sizes, flavors and colors.  ome are constituent parts of contract research organizations (CROs) while others are part of private equity-backed roll-up operations. Still, others may represent independent standalone operations. Some employ physicians/clinical investigators and do traditional site work (e.g. conduct studies) while many others oversee and manage the process. TrialSite News surveyed some of the leading organizations worldwide to educate our readers as to who some of these players are.

The Survey

TrialSite News’ research team focused on select Site Management Organizations (SMOs) that have substantial operations dedicated to offering clinical trial related services with an emphasis on managing systems, processes and trial administrative work for clinical investigational sties.  Sites can range from a hospital or community clinic to a major academic medical center and non-profit research network to commercially focused research centers. The scope of an SMO’s responsibility is typically limited to the site, hence the title. Responsibilities range from supporting sites with business and regulatory administration, negotiations and contract with sponsors to overseeing the process of site activation, and study startup, including support with patient enrollment. 

Most global CROs maintain some site management related services and large sponsors often seek full-service, one-stop shopping with the largest CROs which include: Laboratory Corporation of America (Covance); IQVIA (Quintiles); Syneos Health; PAREXEL, PRA Health Sciences; PPD; Charles River Labs; Wuxi and Medpace. 

This survey will focus on more niche SMO-focused organizations, although they may fall under the operation of a larger CRO—the difference being the SMO in our survey represents a larger share of the overall business.

Australia and Broader SE Asia

Based in Australia and very active in Asia, Novotech fits into the CRO model—that is, it is an internationally recognized, full-service CRO operating mainly in Asia-Pacific from Australia and Hong Kong to Malaysia, Philippines, Singapore, South Korea and Taiwan to Thailand. Established in 1996 and headquartered in Australia, Novotech is a go to partner for many sponsors seeking to do conduct clinical trials in Asia. Novotech brings a tremendous amount of localized knowledge and site management services. Private-equity-backed TPG bought Novotech with the help of four banks in 2017. They presently employ about 500 making them a mid-market sized CRO. 

AusTrials, a CRO with SMO operation, positions itself as a leading operator of private clinical trials facilities in Australia. AusTrials collaborates with research organizations and biopharma sponsors to make clinical trials available in Australia. Their SMO maintains a national network of sites in Australia. They manage a network of primary care centers across the continent—establishing the necessary infrastructure and facilities to conduct GcP/FDA-regulated clinical trials within these centers. Benefits they bring as an SMO include: 1) large patient numbers, 2) centralized site coordination (e.g. streamline contracting, regdocs, etc.), 3) simplified ethics applications, 4) General Practice setting for clinical research as care options, 5) commitment to quality via rigorous quality oversight of all sites, and 6) project management of the on-site study coordinator resources, including KPI-driven management and coaching to ensure delivery to recruitment targets.

Based in Queensland, they employ about 25. Their Managing Director is Munro Neville

Japan

CMIC Group positions itself as “the first CRO in Japan.” Launched back in 1992, this venture, like Novotech, reflects the CRO model inclusive of site management organization services. Headquartered in Japan, they manage 34 offices out of Asia and 14 offices associated with North American affiliates. CMIC’s Site Management Organization (SMO) services purports to be the first such operation in Japan.  By Providing total administrative and practical support ranging from the development of implementation systems for clinical research to execution and operation, their SMO capitalizes on the know-how, experiences and assets under their umbrella. SMO differentiators in Japan include: 1) Know-How & Experience, 2) Localized SMO in Japan; and 3) Collaborative infrastructure with existing sites from major academic medical centers to non-profit research sites in Japan.

EPS International Holdings Ltd. offers SMO services in Japan. A direct competitor to the CMIC Group, they offer SMO services throughout Asia with an emphasis on ensuring sites come through on patient recruitment objectives. They bring to CROs and sponsors pre-established contracts with hospitals and medical institutions to assist with complex trial work ensuring studies are properly conducted per GCP and national regulatory guidelines without interruption. EPS International Holdings’ SMO is part of the EPS Group, a Japanese-based CRO founded in 1990.

Finally, another SMO-based venture in Japan, Ethic, retains more than 250 clinical research coordinators for its SMO offering, based in Tokyo. Formed in 1984, they employ nearly 300. They would be considered on the smaller scale and would potentially help sponsors and CROs in Japan with dedicated, focused SMO services.

Mainland China

Interested in SMO services in China? Consider working directly with a Chinese-based firm—one choice would be Beijing Aisimo Medical Science and Technology Co., Ltd, a professional Site Management Organization (SMO) for the conduct of clinical trials in China. Hence, Beijing Aisimo falls into the SMO category of subsidiary or operating unit within a bigger CRO parent. They appear to be an operating company owned by Chinese CRO Panacro. Founded in 2007, they have approximately 100 employees that operate in more than 20 strategic cities and 300 departments in China have established international-based standard operating procedures. Parent CRO Beijing Panacea Technology Co., Ltd was formed in 2004 and has serviced over a hundred drug sponsors/CROs (at home in China and abroad) centering on more than 20 therapeutic areas; Panacea maintains officers in 20 major provinces or cities in China. It purports to have “close cooperation with 80% of nationwide clinical trial institutions.”

TigerMed represents another Chinese SMO operation unit within a rapidly growing Chinese-focused CRO. The broader CRO is a publicly traded entity employing thousands.   

TigerMed’s SMO offers customized on-site management and clinical operation services for study sites. It offers high-impact, real-time assistance to investigators and study sites involving business, administrative and regulatory services with the objective of improving study quality, acceleration of project process, and promotion of standardization of clinical trials.

Their SMO covers 57 cities across China with a dedicated team of over 1000 professionals making it a formidable operation. They have served over 700 trials in 700 hospitals and offer turnkey SOPs, and other quality and regulatory services for sites based on ICH-GCP and China GCP.

International business development is led by Jessica Liu.  

North America

On to America and the private equity-based site rollup model, ERG Holdings, acquired by private equity from Linden Capital Partners. A clinical investigator site rollup or “Super Site,” it also offers site management organization services. It is comprised of 11 fully owned clinical research facilities and offers comprehensive site oversight and management services for CROs and sponsors. With an emphasis on central nervous system and other specialty therapeutic areas, they manage at least 21 clinical investigational sites across the U.S., according to investor/owner Linden Capital Partners. ERG has completed over 5,000 clinical trials (phase I-IV) via its outpatient and inpatient facilities, offers over 380 beds across America as well as access to more than 215,000 patients and healthy volunteers.

In Southern California, a SMO titled Format Medical Research operates out of Oxnard, California. A hybrid site and SMO model, Format touts is alliance with hyperCORE International, a “Super Network of Premier Research Sites organized by Canada’s based Super Site play LMC Manna Research. Format purports to offer SMO services for up to 50 sites. With between 25 and 50 employees, the SMO seeks to “manage only high producing sites.” They tout that their smallest site has 147 beds and their largest 846 beds. They claim that their network in total covers over 10 million patients and that this allows them to surpass enrollment goals.  Moreover, in addition to SMO services, they report to “spearhead ethics committee and MOH approval in the countries they operate. Format’s CEO has been Nicholas Focil

Michigan Pharmaceutical Research and Development Group, Inc. known as MPR Development Group Inc. is a U.S.-based, privately held company with global reach. A mid-market CRO, they have developed a SMO with global reach. Formed in 2003, the interesting venture has several holdings offering SMO services.

Privately held with dozens of investors, the venture is owned and operated by professionals with medical, pharmaceutical, management, and finance backgrounds. The company has presence in 40 countries.

This translates to considerable global SMO capacity to assist in the implementation of clinical trials. Their global and regional SMOs include:

Africa

For focusing just on Africa, a CRO with a SMO unit, Africa Trials Group or ACTG-CRO seeks to improve health and life in African countries by improving access to healthcare through clinical studies. They are striving to become leading experts in African clinical trials.

A full-service CRO, they are headquartered in Tunisia. Their SMO maintains arrangements with 16 sites in Africa. SMO services ensure all processes and projects remain under GCP controls via the implementation of their in-house, updated, precise SOPs—they can adjust and adopt client SOPs as well—such as working with a large academic medical center. ACTG-CRO was founded by Dr. Karim Khallout after spending several years conducting research for INSERM and academic research institutions.

Turkey and the Middle East

As part of Europe but also a partner of Asia, Turkey bridges the west and the east and represents a strategic portal for clinical researchers into both worlds. Istanbul-based Medex runs an SMO in Turkey. They offer CRO services as well to biotech, pharma and medical device companies. Formed in 2013, they employ approximately 50. Owner Mehmet Yidiz has been involved with clinical research in Turkey for over a decade.

Latin America

In Latin America, some sponsors turn to Cidal. A CRO/SMO that implements and executes clinical trials in Latin America, Cidal implements Phase I through Phase IV studies, from protocol design and initial planning to patient recruitment and the administration and oversight of investigational sites. Formed in 2001, they are estimated to employ between 75 and 150 people. A Director of Business Development is Argentina-based Luis Hernan Ramierez.

Wrap Up: Contact TrialSite News for Custom Requests

Of course, there are many more Site Management Organizations but this cursory survey intends for a high level overview. Should a TrialSite News reader be interested in specific research, contact us and we will determine if we can accommodate any requests.

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