Trial Management Organisations or TMOs exist by a lot of different names: Site Management Organisations, Independent Practice Associations, Site Service Organisations, to name a few. Although called by many different names, the aim of all is the same: to provide services to sites participating in clinical research. You can see the Wikipedia definition here.
Trial Management Organisations assist sites to conduct research. How they assist sites varies from organisation to organisation and site to site. Typically, the TMO would be engaged by the Principal Investigator prior to study start-up to assist him/her in running a particular trial or group of trials. The TMO would project manage the trial by performing all regulatory requirements (including ethical review submissions and maintenance of the trial documents), assisting with recruitment and providing trained staff to perform patient visits, submitting patient data and facilitating monitoring visits. Other services provide by TMOs include financial management, provision of equipment (such as centrifuges, drug fridges etc), seeking out new trials for the investigator and archiving facilities.
There are many advantages to both sites and sponsors in the use of TMOs. The top five advantages to sites are:
- Access to highly trained staff
- Cost effective research
- Regulatory compliance
- Quick study start-up
- Increased patient safety
Clinical research is becoming increasingly complex and regulatory requirements more stringent. This makes finding suitably trained and experienced staff more difficult. Training staff requires a huge investment of time and money that a lot of sites are unable to afford. Employing staff involves costs (and time) associated with processing wages, income tax, superannuation, worker’s compensation insurance and complying with other legal requirements of employing staff. Employing full-time staff is often only economically feasible when undertaking multiple or large research studies. TMOs can provide access to highly skilled staff on an as-needed basis. Sites only pay for the staffing hours that are needed for their study and do not have to worry about human resources management. This has been a huge drawcard for smaller sites who lack resources to employ and train research staff. Increasingly, TMOs are being used by larger sites to fill staffing gaps caused by sick leave, holidays and difficulty in replacing or recruiting staff.
For Sponsors, the use of TMOS leads to:
- Faster patient recruitment
- High-quality, reliable data
- Confidence in regulatory compliance
- Adherence to study timelines
- Multiple sites run by one study team
The real advantage of TMOs is that all the parties – the Sponsor, site, investigator and most importantly the participants – are dealing with study staff who know what they are doing! Trial Management Organisations are experts in their field and, therefore, able to perform study tasks more quickly and at a higher standard than inexperienced staff.
While TMOs are advantageous to sites and Sponsors, the big winners are the participants who can be confident that they are receiving the best possible care and that their safety is being considered every step of the way.