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Clinical Operations and Project Management Services

From Phase 1 through FDA approval

Clinical services are tailored to each sponsor’s requirements and are staffed with only highly qualified professionals. Our clinical operations team ensures sites carefully follow the investigational plan and together we provide our sponsors with confidence about human and animal research protection. Throughout the project, our clinical research professionals use effective interactions with investigational site staff to increase efficiency and provide accurate and reliable data from which to build your clinical program.

With this model, our dynamic teams are well equipped to take your program from Phase 1 through FDA approval. Our project managers collaborate with your internal project team from the start to ensure that we understand your individual needs and priorities. By closely aligning our project management methodology with your team’s needs, we are able to provide a tailored plan that meets your requirements and ensures timely communication and goal completion.

Services
Overview
Clinical Operations and Project Management
Data Management
Biostatistics
Strategic Consulting

Minimized Delays

Our fully integrated, multi-disciplinary team is tailored to meet the needs of your study, armed with consistent communication and a full knowledge of study direction. We have a field-based and in-house clinical research associate (CRA) team structure, allowing field CRAs to communicate study needs to the in-house teammate to remedy obstacles as they arise.

Enrollment Risk Mitigation

At PharPoint, we provide special attention and strategic planning to support the optimization of enrollment, proactively managing potential untoward events such as subject screen challenges and excessive dropouts, which can often be an issue in long trials. PharPoint provides focused internal and site team training on the protocol, study implementation guidelines, and issue escalation processes to mitigate enrollment risks.

Site Selection

Our team works to identify sites that meet enrollment expectations while focusing on subject retention and high-quality study execution. Site selection is based on PharPoint's previous experience with sites as well as information gleaned from performing site feasibility processes and qualification assessments.
  • Global clinical trial project management
  • Clinical monitoring
  • Site feasibility assessments
  • Investigator meeting preparation and presentations
  • Risk mitigation
  • Study startup support
  • Site mangement and communication production
  • Vendor management
  • Interactive Voice Response System (IVRS) vendor selection and oversight
  • Clinical Trials Management System (CTMS)
  • Investigator grant and research budget preparation and administration
  • Study rescues


Nancy Peterson, Associate Director of Clinical Operations

Ms. Peterson has worked in the health care industry since 1989 and is highly experienced in clinical research.

Her career includes US and global experience as a CRA, project manager, business development director, and vendor manager of Phase 1-3 studies. At PharPoint, Ms. Peterson is responsible for operational oversight, periodic team performance reviews to capture best practices, continuous process improvement, and the measurement of stakeholder satisfaction.