Site Monitoring and Management
Site management is a critical aspect of a successful clinical trial. Principal Investigators and their teams are on the front lines of clinical research. They are responsible for implementing protocols, recruiting patients, managing regulatory issues, and reporting data to support study outcomes. Together with study sponsors and CROs, sites improve public health and help bring new treatments to patients worldwide.
When you partner with Emmes to manage your clinical trial, you can be assured we will go to great lengths to support your sites and their patients. We provide sites with a variety of tools and support mechanisms to prepare them for success in conducting your trial. We educate them on the protocol using live and recorded training, study manuals, and a centralized website for trial information. We believe that investing in robust training of site professionals increases compliance with the protocol, ICH GCP, and other regulatory requirements. Proper site training also ensures data and scientific integrity while managing patients through their clinical trial journey.
Site Management Services
- Site identification and feasibility
- Training and education of sites
- Site and patient recruitment
- Site contracting and payment
- Site activation and study support
- Patient enrollment/randomization
- Clinical trial monitoring (on site and remote)
- Data management (e.g., collection, cleaning, query resolution)
- Protocol, ICH GCP, and regulatory compliance support
- Study product, device, and supply inventory and tracking
Emmes is a site-centric CRO
Our philosophy of working with sites is straightforward: Emmes aims to build deep and enduring relationships with investigative site professionals. We are here to help site staff overcome study challenges. Clinical Study Managers (CSMs), Clinical Research Associates (CRAs), and other members of the study team interact with site staff regularly. Together, they leave no stone unturned, no questions unanswered, and no requests for support unsupported.
It is not a coincidence that Emmes excels at building relationships with sites. We recruit empathetic study team members who are great listeners, communicators, and relationship builders. We then provide extensive support throughout the trial lifecycle for them, empowering them to achieve the clinical trial’s goals and objectives on behalf of sponsors.
Supporting Sites Throughout the Clinical Trial Journey
One thing that makes Emmes different from other CROs is the collaborative approach we bring to data management. Our data managers are therapeutically aligned, so they understand the context behind the data they manage for sponsors. Data managers are also integrated members of the study team. They provide data system training sessions, interact with sites, and are available to clients and sites who have questions about the data.
Emmes’ support of your sites begins during study planning and protocol development. We pay attention to the operational feasibility of the protocol. Will sites be able to logistically comply with the protocol? Is the visit schedule and testing regime too burdensome on patients? How easy will it be to collect, enter, and manage the data? What support will sites require to manage protocol and regulatory compliance issues? Approaching the protocol design from the site staff’s perspective gives us the opportunity to work with our clients to create an operationally sound and appealing trial for patients. In a sense, we are advocates of sites from protocol planning through study-closeout.
Upon enrollment launch, Emmes’ clinical study teams and data management professionals work closely to ensure sites enter data correctly and in a timely manner. We review your patients’ laboratory results to make sure that values are within range and patients remain safe during the trial. And we collaborate with sponsors and internal clinical pharmacovigilance experts to track and resolve safety events, as patient safety is sacred to Emmes and our clients.