Clinical Trial Operations and Logistics

Our operation’s teams are guided by robust procedures and processes that support participant safety, protocol compliance, data quality, efficient study completion, and timely publication and dissemination of results.

Our Clinical Operation’s teams comprises of Project Managers, Clinical Trial Managers, Clinical Research Associates/ Trial Monitors, and Clinical Trial Assistants who will work hand in hand with you to ensure your study’s success.

Our operations teams are guided by robust procedures and processes that support participant safety, protocol compliance, data quality, efficient study completion, and timely publication and dissemination of results.

At UCTSS, we will partner with your preferred logistics and supply vendor to establish a well-defined and robust supply chain process per study.

These operations include

Site selection and qualification

We provide resources and infrastructures necessary to conduct clinical trials such as hospitals, medical centres, and local healthcare centers. These are offered in locations nationwide that suit your study requirements and patient distribution or disease prevalence.

We have a strong national coverage of sites that have been prequalified to be considered to participate in our clinical studies. We have taken our time to develop a database of sites that are ready to kick start your journey with you whenever you are ready.
We have implemented an initial process of qualifying these sites to ensure they meet the basic requirements of conducting clinical trials, cross matched them with therapeutic areas, bed spaces, staff qualification and site resources.
Our sites undergo what we call a triple barrel qualification process in terms of proximity, accessibility and capability in relation to the patient needs and study requirements. Our sites are a mix of Federal, state and private institutions with resources and infrastructures necessary to conduct clinical trial.

Our processes for Site Selection Visit (SSV)/ Pre-Study Qualification Visit (PSQV) are guided by well laid out SOPs ensuring all GCP and regulatory requirements are satisfied. This strategy engages qualifications in terms of space, adequate staff, size of site, no of patients, availability of required equipment and many more.

Additionally, we factor in the facilities overall ability to meet the trial and regulatory requirements before including them in the selection process. Moreover we deploy study alliance specialist to each site to always ensure compliance.

Site management and monitoring

We provide site management and monitoring support throughout all phases of your clinical trials with experienced clinical research associates (CRA) or monitors that would work with your sites to achieve your planned study end points. We are hands on from study start-up, conduct, and study closure.

The following Site Management & Monitoring services are provided:

Site Selection and qualifications
Regulatory document collections
Assistance with competent authority submissions and communications of changes as applicable.
Site Initiation Visits (SIVs)
Site Monitoring Visits
Site Closeout visits
Site Communication including escalations and issue resolutions.
TMF Management (electronic or Paper)
General oversight and investigator support.

Patient management

Participant recruitment and retention are two major bottlenecks in conducting clinical trials and contribute vastly to the success or failure of any trial. Participant recruitment takes the bulk of the timeline and resources.

Identifying, sourcing and on boarding of patients/participants is a major feat for any clinical trial especially in an unfamiliar terrain like Nigeria.

Participants profiling

UCTSS will conduct preliminary profiling of prospective patients to ensure patients are well educated on the requirements of participating in clinical trials, This is usually a group forum where participants are given the opportunity to engage with our team of health professionals. They are given adequate information to help them make quality decision about their health and participation in such studies. We allow the patients to come to us before initiating the informed consent process.

This strategy, among others, are steered by our team of professionals to ensure that the patients are well • informed about the trial, consenting without pressure are recruited and sustained through the period of the trial.

With our wide network around a population of over 50 million people in the urban areas, effective patient recruitment is achieved.

Investigators Recruitment

At UCTSS, we have a curated list of Investigators, who are qualified and experienced in conducting trials. We work with them to ensure their commitment to the trial once sites have been activated. Investigator meetings are highly encouraged in Nigeria as the interactions and networking amongst participating sites tend to create a kindred type of relationship and assures the site of communal support when required. We provide extensive trainings for sites, planned and ad hoc as we ensure all sites are overseen and proactively managed by our SAS.