Site Start up

Genesis Research focuses around fast start-up and ensures that the various processes involved in a typical start-up of clinical trial has been documented, simplified. Continuous improvement techniques are also used to further shorten start-up activities...

Amongst these processes, the data collection process from sites is completely stream-lined so that the customer has a single-point of contact for reaching out to all sites in the Genesis Research network.

Genesis Research can contract with the customer directly, and has already developed individual contracts with each of the sites where it operates from. This can help shorten the contracting process dramatically. However, each customer can have specific contract language they want and this can also be managed centrally across the network of sites.

To assess your trial's likelihood of success at our sites, we perform a Protocol Feasibility Assessment at no cost.

Trial Management

Genesis Research can take responsibility for choosing the right sites for your protocol, helping start the study in quick time and then helping in driving recruitment with the PI at each site ensuring good quality patient data from each of the sites. Genesis Research has entered into agreements with a large number of sites across the regions we operate in. We ensure that these sites are prepared with basic physical infrastructure, well-functioning ethics processes and experienced investigators and site staff.

Once a project is contracted by Genesis Research, a single point of accountability is created within the organization and trained resources are deployed at the selected sites for the study. The resources at site are supported and guided by experienced people whose responsibility is to make sure the processes are adhered to in letter and spirit, and to establish a connection with the investigator at each site.

Patient Recruitment and Retention

Genesis Research has developed and continued to evolve, therapeutically customized patient recruitment processes in consultation with medical professionals in each region of our operation. This helps in adapting these processes for local nuances and in keeping with the medical protocol in each region. These cover a wide variety of options that can be pursued by the investigator i.e.

• Addition of co-investigators who can refer their patients into the trial, using the same infrastructure and same cost structure, to make the site more productive

• Creation of a database at the site so that various patient parameters can be entered and maintained over a period of time, and then screening is easier for the investigators - especially for complicated protocols

• Working with social workers and nurses to reach out into the community and promote the adoption of clinical trials

Genesis Research has also been effective in maintaining high retention of the subjects in every trial. This has been possible because of close working with the investigator to understand the potential drop out reasons, manage those risks on a pro-active manner and to communicate on a regular basis with subjects in the trial.

There have been studies where Genesis Research staff members have visited subject homes to clarify issues with the family and / or the community and bring the subjects back into the trial. Patient recruitment services are provided as part of the full trial management service, but for special cases, this could be offered as a stand-alone service.