RESEARCH DEVELOPMENT AND EXECUTION

Advancing research on time and on budget

Tailored services supporting research teams to ensure desired outcomes and stay on-track through all stages of the protocol life cycle

CLINICAL PROJECT MANAGEMENT SERVICES
Let our project managers help keep your research on track, from start up through close out.
RCNet COORDINATOR SERVICES
On-site research coordinators can step into your project at any stage to keep the research moving forward.
PROTOCOL START UP SERVICES
Our experienced teams can help you accelerate your research applications and approvals.

Tailored Services to Ensure Research Objectives and Stay On-Track

Supporting research teams to ensure desired outcomes through all stages of the protocol life cycle

Clinical Project Management Services

Let our project managers help keep your research on track, from start up through close out.

RCNet Coordinator Services

On-site research coordinators can step into your project at any stage to keep the research moving forward.

Study Start-up Services

Our experienced teams can help you accelerate your research applications and approvals.

Clinical Project Management Services

The CCI has an experienced project management team that can be involved in all stages of the protocol life cycle. The project management team prepares study materials such as the protocol, case report forms, and informed consent documents. Our project managers are experienced in establishing the necessary documentation for IRB and/or Ethics Committee approval. The team is also instrumental in preparing and supporting protocols during initial meetings with the FDA and other regulatory bodies. They conduct pre-investigational visits to train site staff on the protocol, study materials, applicable regulations, and Good Clinical Practice. The team produces frequent reports and communications to keep investigators apprised of data accrual and quality on a site-by-site basis and keep the study team on track.

Services

  • Function as a resource for BWH coordinators and PIs
  • Coordinate the implementation of both internal and external clinical research studies
  • Monitor trial progress to ensure compliance and adherence to the project plan and identify, evaluate and rectify problems
  • Function as a point of contact for the clinical trial

RCNet Coordinator Services

The Research Coordinator Network (RCNet) provides investigators with a source for reliable and experienced research coordinators for clinical investigation. Coordinators are on hand to work simultaneously on a variety of protocols throughout the hospital, on a part- or full-time basis. Research coordinators are well-versed in the intricacies of IRB and FDA regulations, as well as sponsor-related documentation, and support protocol development and applications, subject recruitment and screening, and subject visit coordination and support, and data collection. RCNet staff are also familiar with the BWH facility and are prepared to assist new investigators in training new or inexperienced research staff.

Services

  • Start-up support
  • Research coordination support
  • Recruitment, screening, and enrollment of study subjects
  • Development and completion of all study documents: physician orders, demographic forms, CRFs, study folders, etc
  • Creation and maintenance of subject retention and recruitment records
  • Phlebotomy, specimen processing, and shipping
  • Conduct study protocol, activities, and procedures.
  • Close-out support
  • Assist in responding to queries from the sponsor
  • Return all research material to the sponsor
  • Complete progress and close-out reports

Office Hours

RCNet is now offering recruitment related services to investigators and or their related research team members. This service is primarily intended for assistance in constructing the recruitment plan for a new study. Office hours will be by appointment only and take place on Thursdays from 1:00 PM-2:00 PM.  If you would like to learn more, please contact: cci@bwh.harvard.edu
A recruitment/planning template will be made available to walk you through each step of the recruitment planning process. Please visit the Additional CCI resources page for the templates.

Study Start-up Services

We can help you get research activities up and running, in accordance with study sponsors, regulatory  and IRB requirements, and site startup guidelines.

Services

  • Protocol preparation: conversion from clinical research to industry protocol to IRB and regulatory documents
  • Center for Clinical Investigation application preparation
  • Coordination of the site initiation visit
  • Assistance in the completion and submission of IRB forms

Ready to move forward?

We can help assess next steps, problem solve, and remove roadblocks holding you back.

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