Center for Clinical & Translational Science

The Center for Clinical & Translational Science is a closely-linked, multi-disciplinary scientific enterprise in which basic, clinical and translational researchers plan and conduct studies as collaborators and scientific colleagues.

With the tripod of research, education and patient care as the center of our endeavor, we forge the interdisciplinary divide between clinical, translational, and basic research.

We provide the opportunity and environment for translational research to flourish through mentoring from established investigators to junior scientists. We have established core facilities to enhance and facilitate translational research being performed by an assembled group of basic and clinical researchers at  MHIR.

The Grants and Contracts Office promotes the research enterprise across MaineHealth by assisting Investigators with preparation and submission of grant applications, developing research contracts and sub-award agreements, and managing research grants and contracts once they are awarded.

The Office provides advice on federal research policies, identifies and distributes funding opportunities, provides guidance on legal aspects of research agreements, develops institutional policies and provide a diverse array of assistance to investigators in the grantsmanship and contracting process.

The Contract Office coordinates and processes all research-related contracts, including Confidentiality Agreements, Clinical Trial Agreements, Registry Agreements, Data Use/Data Transfer Agreements, Consulting Agreements, Research Services Agreements, Research Physician Services Agreements, IRB Agreements, and Corresponding Agreement Amendments.

The Contracts Office also works closely with the Clinical Trials Office Project Management and Research Accounting to maintain consistency in contract language in relation to payment and finance terms and conditions.  Additional services include:

• General legal recommendations with regard to research activities, services, studies, projects and policy
• Consults with Maine Health Legal Affairs, as necessary, to facilitate institutional consistency with regard to legal policy and procedure

Financial Services

Our Project Management Team is responsible for facilitating the planning and implementation of various phases of clinical research projects for Maine Medical Center (MMC) and affiliated hospitals. The PM team collaborates with multiple departments to provide assistance with investigator-initiated and industry-sponsored studies, including:

• Study start-up administration
• Cost assessment, logistical planning, and feasibility
• Budget and contract negotiation
• Billing and compliance
• Project closeout
• Program development and process improvement

Please see the Ancillary Fee Schedule

Pharmacy

The Maine Medical Center Research Pharmacy is a fully operational pharmacy staffed with a full time pharmacist and technician.  The Research Pharmacy aims to maintain control and accountability of research medications used in the care of patients in order to provide maximum benefit and safety to those participating in each study.  The research department services Maine Medical Center and Maine Medical Partners patients.

Management of research medications includes, but not limited to the following services:

• Secure storage, procurement , inventory, subject randomization,  accountability and disposal of investigational drugs according to protocol requirements
• Drug product distribution to clinical study sites
• Inpatient and outpatient study drug dispensing
• Preparation of both sterile and non-sterile compounding including chemotherapy
• Facilitate monitoring visits

Radiology

The Department of Radiology at Maine Medical Center provides a full range of imaging services performing over 180,000 exams per year which includes about 25,000 CT scans, 17,000 US studies 8,000 Vascular /interventional, 5,000 nuclear medicine studies and 10,000 MRI exams total.

The radiology physician staff includes 38 Diagnostic Radiologists with subspecialty expertise including angio/interventional, neuroradiology (CT, MR, myelography), nuclear medicine, abdominal imaging (CT, US), mammography, GI, GU, chest, musculoskeletal and pediatric radiology, and 6 Radiation Oncologists who provide diagnostic, therapeutic and consultative radiologic services using the most advanced equipment available and are supported by professional and knowledgeable staff.

This expertise lends itself to high quality support in clinical research trials.  In additional to the full range of imaging services, the Radiology department provides:

• Streamlined research review process
• Radiation Safety Committee Protocol Review
• Standard Examiner Quality Assurance
• Adheres to protocol specific requirements, i.e. RECIST

Research Ethics & Compliance

The Office of Research Ethics & Compliance is responsible for providing training and support to clinicians, faculty and staff in regulatory requirements for scientific research. It also seeks to promote and ensure the highest standards for research compliance throughout MaineHealth.

Human Research Protection Program

The MMC Human Research Protection Plan (MMC HRPP) is a comprehensive system to ensure the protection of the rights and welfare of human research subjects. All individuals within Maine Medical Center and the physicians from Maine Medical Partners are responsible to:

• Be aware of the definition of human research.
• Consult with MMC IRB when there is uncertainty about whether an activity if human research.
• Not conduct human research or all human research to be conducted without review and approval by the MMC IRB.

Nordx Laboratory Services

NorDx is a vital resource in the Northeast regional healthcare community. We are committed to supporting our partners in healthcare by providing superior quality and cost-effective laboratory services which emphasize customer satisfaction, value, innovation, technology, and exceptional service. We provide comprehensive, dependable laboratory services to hospitals, networks, physician offices, post-acute and long-term care providers, managed care organizations, and employer groups throughout the region.

MHIR Research Laboratory Services

The MHIR Research Laboratory Services is equipped with high throughput instrumentation for analysis of autoimmune disease, bone metabolism, cardiovascular disease, infectious disease, inflammation, metabolic syndrome, obesity, diabetes, renal function, reproductive endocrinology and thyroid function.

The lab also offers enzyme-linked immunoassays (ELISA), colorimetric and radioimmunoassays (RIA) for measurement of a comprehensive array of metabolic biomarkers in both human and murine specimens.