Brigham and Women’s Hospital

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Brigham and Women’s Hospital

The Center for Clinical Investigation (CCI) is the home of Harvard Catalyst at Brigham and Women’s Hospital. The CCI supports investigators and facilitates clinical research to accelerate discoveries for better health. Our mission is to maximize our investigators’ ability to conduct clinical research as effectively and accurately as possible by providing a cost-effective option for commonly needed research services, as well as specialized support options, to meet the needs of investigators through the life cycle of a research protocol. Investigators that use CCI services are supported by National Institutes of Health (NIH), federal agencies, foundations, academic centers, hospital departments, and industry, and conduct protocols across a wide variety of therapeutic areas.

Our support to investigators spans the lifecycle of a protocol including Research Innovation Design and Analysis Services, Research Development and Execution Services, and Research Clinical Operations.

Research Innovation Design and Analysis

Early Stage Design and Innovation Services

Our integrated team of experienced and practical clinical research investigators, clinical operations staff, clinical project managers, biostatisticians and regulatory experts help investigators design research and write protocols that maximize data discovery from the study and reduce overall costs, without jeopardizing the integrity of primary and secondary objectives. Our research-experienced innovation team and interdisciplinary group of advisers conduct scientific and strategic evaluation of research projects for commercial viability. These services are focused on accelerating the transition of innovation in devices, diagnostics, therapeutics, and medical software from pre-clinical/prototype to first-in-human clinical trials.

Regulatory Affairs Services

CCI facilitates global regulatory affairs services for all stages of pharmaceutical, biologic, and medical device product development and lifecycle management, including consulting services for clinical trial applications, marketing applications, medical devices, medical writing, publishing and submissions, lifecycle management, preclinical and chemistry, manufacturing and controls consulting, agency interactions, strategic consulting, and intelligence and quality review.

Documenting pharmaceutical quality/chemistry, manufacturing, and controls; obtaining scientific advice and protocol assistance; following the FDA’s Physician Labeling Rule; adhering to scientific guidelines implementing regulatory requirements.

Insight on FDA regulatory environments, smooth transitions from exploratory to confirmatory stages of investigational drugs, expedited submissions for possible acceleration of the developmental process, facilitated approval of applications to conduct clinical trials of new drugs, responses to regulatory body requests for information.

Biostatistics Services

Biostatisticians provide statistical collaboration by performing the analyses and writing the methods and results sections of manuscripts and answering any questions that arise in the editorial review process. Informal consultations are also available.

The CCI Biostatistics Consulting Service provides support for small, single center studies and multicenter international clinical studies. This support is available to the research community for statistical consulting on issues such as study design, data analysis for protocol development and grant applications, design support for pilot projects and grants, and data analysis for abstracts, manuscripts, and presentations. This service provides an alternative for investigators who traditionally may have resorted to finding independent biostatisticians through local resources like the Harvard School of Public Health.

Data Management Services

Our data management team works with investigators to evaluate concepts and practical methods to support planning, collection, storage, and dissemination of data in clinical research. Our team can help investigators deploy a data capture system, design case report forms (CRF), set-up and validate a study database, review and verify data, and provide data in a format ready for submission to regulatory authorities through final database lock.

Research Development and Execution

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.

Research Coordination 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.

Research Clinical Operations

Implementation Services

The CCI operations team works with investigators throughout the phases of a protocol, providing support on resource planning and pricing, ancillary support pricing, resource application guidance, Harvard Catalyst funding application guidance, site implementation and start-up guidance, scheduling support, and project management support. Our operations team is experienced in developing a deep understanding of protocol needs and crafting custom operational solutions.

Clinical Research Facilities

Inpatient
Dedicated inpatient research space embedded in the BWH campus is supported by research-experienced staff and can accommodate complex research requirements and ensure the safety of research subjects. Inpatient visits are supported by nurses, nurse practitioners, physician’s assistants, and dieticians and direct research pharmacy support. Clinician staff are expert in carrying out sophisticated clinical research activities including clamps, infusions, and chemo-certified drug administration. The unit’s location within BWH ensures the safety of patients should any serious adverse events occur. A simple processing laboratory is co-located with the unit and is available 24×7. Additional resources for study teams include meeting space, computers, and scheduling support.

Tower 9A includes six inpatient beds outfitted for telemetry monitoring for inpatient or specialized outpatient studies. Tower 9A units are available for inpatient studies as well as outpatient procedures that require more than 12 hours of intense nursing support.

Tower 9B boasts start-of-the-art technology to monitor subjects for studies requiring environmental standardization. It offers five suites outfitted for telemetry monitoring and designed to carry out studies in which nearly all environmental cues (e.g., environmental standardization of temperature, light, and outside stimuli) can be controlled. Each suite is constructed on an independent “floating” cement floor platform and is self-contained, soundproof, lightproof, and specifically designed with an anteroom for added temporal isolation. This facility also contains a highly sophisticated computer system to control and monitor many environmental factors (light, temperature, humidity, sound) and physiologic functions (blood, saliva, and urine sampling, EEG/sleep recording, neurobehavioral performance testing). This intensive physiological monitoring is often used in support of sleep research.

Outpatient
Our outpatient clinical research infrastructure provides cost-effective and convenient access to dedicated clinical-research space. Each of our four outpatient clinics is supported by our outpatient clinician team of phlebotomists, research nurses, nurse practitioners, physician’s assistants, and dieticians. A simple processing laboratory is co-located with each clinic. Additional resources for study teams at each location include meeting space, computer workstations, and scheduling support.

Ambulatory Clinical Center (ACC)
Located at 221 Longwood Ave, this clinic includes a waiting room, five patient-friendly examination rooms, phlebotomy chair, staff workstation area, a metabolic kitchen, patient dining room, conference area, and a specimen processing and storage laboratory. The ACC is ideal for minimally invasive, lower-risk studies.

Clinical Trial Center (CTC)
Conveniently located in the heart of the BWH campus in Building A4, Elevator C off the Pike. This clinic houses a reception area, four exam rooms, phlebotomy chair, and a small laboratory for processing and storing specimens. Each exam room also functions as an infusion center, equipped to deliver controlled-rate intravenous infusions to patients with appropriate hemodynamic monitoring. This unit supports more complex, invasive research studies.

Clinical Trial Hub (CTH)
Our newest facility in the Hale Building for Transformative Medicine. Opened in 2017, this clinic hosts a reception area, three exam rooms, a consult room, an infusion suite, and a small laboratory for processing and storing specimens. The infusion suite offers three bays equipped to deliver controlled-rate intravenous infusions to patients with appropriate hemodynamic monitoring. This clinic supports longer, complex research visits which often include infusions.

Research Off-Campus Clinic
830 Boylston (ROC-B) is the Center for Clinical Investigation’s new outpatient research clinic. Recognizing that COVID-19 will be a factor in the foreseeable future, the CCI has modified facilities, schedules and safety protocols to prevent the spread of infectious disease and offer a safe care research environment for staff, research teams and subjects. This new clinic expands the safe care research environment beyond the main BWH campus, offering an alternate facility for research visits and subjects that don’t require the resources of the main hospital.

Sample Processing Laboratories
We offer on-site 24×7 simple processing support and preferred pricing access to diagnostic laboratories. On-site services for high quality, standardized routine processing are available at all of the CCI’s research units. Our technicians perform specimen processing and shipping services, sample handling and processing, basic sample handling, labeling, serum separation, and blood sample centrifugation. The Lab also offers short-term specimen storage. Advanced services include PK study support, PBMC isolation and other specialized processing. For ancillary support, the CCI has negotiated preferred rates for investigators for ancillary support at partnership labs, including a commercial laboratory, BWH BRAC Labs, or BWH Stat Labs. (Analysis is performed, and results obtained through the partner labs.)

We recently opened a BL2+ lab on BWH’s main campus to process infectious samples, including COVID+ samples. This lab has 2 biosafety cabinets, centrifuges with sealed rotors, and an incubator. The equipment will allow investigators to study biological sampling of blood, nasal and lower respiratory secretions in order to identify immunophenotypic and genomic features. The lab follows all OSHA Bloodborne Pathogen Standards as well as staff process samples wearing the appropriate PPE.

Walk-in Phlebotomy
CCI has established walk-in phlebotomy and processing services as a means to help study teams accelerate research activities. Walk-in phlebotomy and processing services are available at the Clinical Trials Hub (CTH – BTM3040, 60 Fenwood Rd) from 8:00am – 2:00pm, Monday through Friday. Walk-in services will be available to all current and future approved studies at the CCI.

Pediatric and Newborn Research Center
CCI collaborates with the BWH NICU to facilitate access to the BWH NICU’s research footprint and cutting-edge neonatal care for studies in pediatric newborn medicine. Pediatric Newborn Medicine’s NICU facility supports research for new ideas to improve neonatal care, including lung disease, neonatal neurology, and infant development. Recruitment and enrollment success is built upon a family-centered approach for research engagement including education of clinical staff and a personalized welcome and research orientation for all families with an infant admitted and eligible for potential research opportunities.

Radiology and Imaging
CCI collaboration facilitates investigator access to research imaging services, image scheduling, image acquisition, and image storage, at BWH.

Clinical Support Services
Highly experienced research clinicians offer clinical excellence across a variety of research protocols and methods.

Advanced Services (mid-level practitioners)
Nurse practitioners and physician’s assistants collaborate with designated physicians and research team members, participate in the informed consent process, and provide education for patients considering enrollment or enrolled in a clinical trial. Mid-level practitioners provide exemplary patient care and work with investigators to define and perform clinical responsibilities in study visits including monitoring toxicities, assessing clinical responses, medical histories, and physical exams.

Nursing
Research-experienced nurses provide assessment and monitoring, infusions, IV placement, timed bloods, OGTTs, collaboration with BWH Investigational Drug Service, investigational drug administration, and patient education. Our nurses ensure participant safety and informed consent, integrity of protocol implementation, and accuracy of data collection and recording. Services are offered in both outpatient and inpatient units, and off-site as well.

Nutrition
Research dieticians provide education, training, and mentorship for investigators, students, and colleagues in areas of nutrition research methodology, study design, and implementation. Metabolic and nutritional services offered include anthropometry, bioelectrical impedance analysis, calorimetry, nutrient-controlled meal development and preparation, and food record analysis in support of both inpatient and outpatient studies.

IPM Circadian Technicians
Intensive Physiologic Monitoring (IPM) circadian (sleep) technicians are specifically trained for the high-intensity schedule of events in IPM protocols. Our technicians manage event schedules, utilize data collection systems, monitor and documents IPM participants throughout wake and sleep periods, collect, measure, and aliquot samples, and administer and monitor IPM participant completion of written assessments.

Phlebotomists and Laboratory Technicians
Laboratory technicians are experienced with many research techniques and activities and support visits by providing phlebotomy, automated BP/HR/O2 Sat/RR/ECG, specimen collection, and specimen basic processing services. All our technicians are International Air Transport Association (IATA) certified to ship biological specimens both domestically and internationally using any courier (e.g., FedEx, UPS). Lab techs are also experienced in working with many pharmaceutical companies and commercial testing labs.

Clinical Skills Training Center Phlebotomy Training
Training for study staff who draw blood for clinical research studies and consists of three parts: a lecture on phlebotomy procedures, an observed phlebotomy on a simulation device, and practice venipuncture on a simulation device.

EKG/Vital Signs Course
Introduce the concepts of vital sign monitoring, anatomical landmarks, fundamental physiology of vital signs, EKG lead placements and safety guidelines. Vital signs included are temperature, pulse, respiration rate, and blood pressure. Underlying the demonstrations of taking vital signs and performing EKGs will be the concepts of standard precautions, patient identification, interpersonal communication, and accurate documentation.

Investigational Drug Services (IDS)
CCI staff facilitates coordination with IDS for pharmaceutical services and guidance in support of all research groups and investigators. IDS ensures delivery of high-quality pharmaceutical care, adhering to all laws and regulations while minimizing the risks associated with participation in an investigational drug trial. Services include drug handling and control, compliance with FDA, state, and hospital requirements, assistance in proper and accurate record keeping, establishment of randomization procedures and schemes, providing drug information and education, preparing sterile and non-sterile compounding, minimizing problems with the availability, preparation, and storage of study drugs, and promoting and assuring patient safety. Investigational drugs and study-related information are accessible 24 hours a day, seven days a week.