The proper planning, execution, and ongoing maintenance of your study are crucial to its success. At ExperTrials, we understand that trustworthy and experienced Clinical Operations team members are critical components to this process.
Whether working through site feasibilities, ongoing monitoring, or study close-out, our Clinical Operations team will work closely with you to reach your trial goals.
Regardless of the number of sites and/or geographic locations, ExperTrials can deliver clinical operations services that accommodate your study’s specific needs.
ExperTrials provides a dedicated International Project Manager for your clinical study:
Therapeutic, phase, and sponsor alignment
Primary liaison with sponsor and study team/vendors (data management, statistics, medical monitoring, safety, clinical research consultants, central laboratory…)
Accountability for overall study logistics, timelines and budget
With our clinical expertise, we will help you :
Respec timelines with targeted patient recruitment and retention
Reduce site and investigator burden by implementing robust identification, feasibility, and selection standards
Identify challenges and opportunities for each site with operationalised protocol development and review
Lead with data-driven project management through consistent review of performance and trends thanks to efficient CTMS
Ensure study start-up, maintenance, and close-out are performed per ICH/GCP, local regulations, and our SOPs
Develop a customised monitoring approach ranging from 100% SDV to complete Risk-Based Monitoring (RBM). This process starts before the protocol is written and is incorporated into the protocol and a Quality Risk Management Plan to focus on Key Performance Indicators (KPI)
Our project managers are the central points of coordination for all tracking and reporting on behalf of the study team.
ExperTrials uses one of the most powerful clinical management tool in the industry: the Clinical Trial Management System from Medidata.
This allows you to have access to your study progress everywhere and in real time.
ExperTrials resourcing model is based on the collaboration of highly experienced Clinical Research Consultant (CRC) in each participating country of your trial.
The Clinical Research Consultant role will be to be in charge of the regulatory submissions to get the Clinical Trial Authorization and monitoring activities throughout the trial. CRCs are familiar with local culture, thus ensuring an efficient service that can resolve local barriers.
Clinical monitoring services include full-service monitoring, as well as risk-based and centralised monitoring services, depending upon your goals and the needs of your project. On average, ExperTrials’ CRCs have over 10 years’ experience in Clinical Research.
Our Clinical services include :
Site identification and selection
Budget negotiation and site contracts implementation
Essential documents collection and processing
Site initiation, interim monitoring, and study closure visits
Overall site management and communication
Site training and audit support
It has been estimated that 30% of patients drop out of a clinical trial and 85% of clinical trials fail to retain enough patients*
*Source: Nuttal, Aidan “Considerations for improving patient recruitment into clinical trials”
By identifying recruitment challenges early and quickly, we can tailor the enrollment plan. We work closely with project teams to analyse target patient population and study specific enrollment criteria. This is critical to recruitment success.
We set up in place the following strategy for the enrollment and patient’s retention :
Education tools across multiple media (print, videos, internet)
Community training sessions
Referral network planning (and related tools)
Google search optimisation
Close communication with sites in order to identify patients that are likely to drop out, understand the reasons and intervene quickly
Patient’s travel reimbursement
Use of home nursing provider for study visits which can be done at patient’s homes
We work hard to ensure that the patients remain in the programme.