Clinical Trial and Site Management

Clinical Trial Management

Clinical trial site management is a critical aspect of your trial’s success.

As your clinical trial and site management partner, we go to great lengths to support your sites and their patients.

We provide a variety of tools and support mechanisms to prepare for trial success. Our Clinical Trial Manager is responsible for ensuring sites are set up for success and fostering a relationship which starts at site feasibility and builds through activation, maintenance, and closure. The ultimate mission of our clinical team is to ensure the rights, safety, and wellbeing of trial participants, while focusing on data and scientific integrity.

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Site Management Services

Site Management Services

  • Site identification and feasibility
  • Training and education of site staff
  • Site and patient recruitment strategies
  • Site contracting and payment
  • Site activation and study support
  • Patient enrollment/randomization
  • Clinical trial monitoring (on site, remote, and centralized)
  • Data management (e.g., collection, cleaning, query resolution)
  • Protocol, ICH GCP, and regulatory compliance support
  • Study product, device, and supply inventory and tracking
  • Inspection readiness and preparation

Emmes is a site and patient centric CRO

Our philosophy is straightforward: our site management and monitoring team helps site staff overcome study challenges by building deep and enduring relationships.

We do that by recruiting team members who are empathetic, great listeners and communicators. Building trust between the site staff and the Emmes project team is paramount and is accomplished by being knowledgeable about the protocol/study, being available for support    
and questions, and championing true teamwork, collaboration, and innovation amongst all members of the team.

Supporting Sites and Patients Throughout the Clinical Trial Journey

We’re different because we bring a collaborative approach to site management. We become site and patient advocates starting with protocol development by providing input to ensure protocols are
operationalizable and minimize burden on site staff and patients.

Our data managers are both integrated study team members and therapeutically aligned, so they understand the context behind the data. Clients and sites benefit from system training sessions, frequent interactions and the opportunity to ask questions.

From study planning and protocol development, and paying attention to the operational feasibility, we ask all the right questions: Can sites comply logistically 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?

By approaching the protocol design from various perspectives, we can work with you to create an operationally sound and appealing trial.

From study launch, our clinical study team and data management professionals work closely to ensure correct and timely data entry. We review your patients’ laboratory results to make sure the values
are within range and patients remain safe during the trial. We collaborate with sponsors and internal clinical pharmacovigilance experts to track and resolve safety events.

Patient safety is paramount to us and our clients.