Study Activation
To hasten trial activation, contract and budget processes are conducted in parallel with scientific and IRB review. Our centralized contract office team is responsible for legal language, with approximately 30 master agreements on file to expedite negotiations. We also utilize an e-signature process via DocuSign® to eliminate administrative burden and decrease time required for wet ink signatures. We can provide desired terms in advance as a standard template to streamline the process.
The CCRO provides financial specialists who work on new clinical trials. We perform a comprehensive coverage analysis to determine items or services considered standard of care, followed by a detailed cost analysis using the protocol, manuals and investigational brochure, if applicable. We have a standard budget template that is detailed and transparent, but have also developed sponsor-specific rate cards to facilitate smooth budget negotiations and provide our site fees in advance.
Our Institutional Rates
Our goal is to be cost neutral, with a standard fee schedule updated each calendar year and applied consistently across programs to external sponsors. Our personnel rates are within fair market value and reflect protocol requirements. We are a non-profit organization with strict policies prohibiting underwriting research costs and preventing unnecessary surpluses.
All study activation workstreams (IRB, contract, budget) are conducted in parallel, however IRB approval notification will not be released until a final contract is signed. We typically utilize central commercial IRB but can use Hartford HealthCare local IRB as needed. A dedicated regulatory analyst is assigned to each study from beginning to end to facilitate opening and ongoing maintenance of required documentation and regulatory compliance.
IRB Policies, Fees, FWA and Membership
All studies are shepherded through the process by a highly sophisticated project manager to ensure timely activation, mitigate unnecessary delays and monitor progress and deliverables through the activation continuum. Our standard activation times are 12 to 18 weeks.
Rapid Activation
Rapid activation - an exclusive, fast-track mechanism for study activation – is reserved for high-priority studies at HHCCI. Rapid activation target timelines are 56 days from time of site selection to open to accrual, compared to standard 90-day timelines*.
Priority studies essentially skip the study activation queue and are assigned additional resources to meet aggressive timelines. Additionally, an oncology research leadership team member, with authority to make swift executive decisions, is assigned to ensure project success by monitoring progress and removing bottlenecks in real time.
Rapid activation requires approval by the Research Leadership Council, which critically evaluates opportunities to assess the:
- Degree of alignment with our strategic initiatives
- Relationship to balance scorecard focus areas
- Internal capacity to ensure adequate resources to reliably deliver
- Return on investment
*Timelines are calculated from study selection official memo or Disease Management Team approval notification. All days are calculated in workdays, including the first day and excluding the last day, weekends and public holidays.
Research Laboratory and Biospecimen Management
The clinical research laboratory is fully equipped with the following instrumentation: refrigerated centrifuge, ambient centrifuge, -20ºF freezer, -80ºF freezer, 32ºF refrigerator, laboratory hood, water bath, Vortex machine, calibrated pipettes, dry ice and supplies. All freezers/refrigerators are on daily temperature monitoring and records are meticulously kept and stored for documentation. These main instruments are also on red outlet plugs that trigger backup generator electricity if needed.
HHCCI clinical and research managers are on an on-call backup paging system and are immediately notified should any freezers/refrigerators malfunction after hours or on weekends. All our instrumentation is calibrated before use and maintained yearly by the Biomedical Engineering Services Department.
Adjacent to the Clinical Innovations Unit, the research laboratory and its expert staff perform complex processing for early phase clinical trials. Our dedicated bio-specimen team includes a unit leader, two research coordinators and a pathology assistant who are IATA-certified to support clinical and translational research across the HHCCI. The team is responsible for timed specimen collection, processing, storing, tracking, inventory management and shipping. Complex processing utilizes the research laboratory rather than the clinical laboratory. Research coordinators and biospecimen research laboratory staff complete all shipping and handling.
Investigational Pharmacy
Hartford HealthCare’s investigational study drug program provides high-quality services regarding investigational medications used in clinical research here. This includes meeting all regulatory requirements associated with storage, preparation, management and dispensing of investigational medications. Research pharmacists support and collaborate with HHC’s research community to facilitate successful outcomes for projects.
The research pharmacy on the Hartford campus provides 24/7 inpatient services, outpatient specialty pharmacy five days per week, and outpatient infusion staffing six days per week. There is a dedicated IDS manager who oversees research pharmacy across all campuses, and IDS can provide standard drug preparation capability with BSL2 capacity. The research pharmacy is fully equipped to perform oncology clinical trials including but not limited to refrigerators, -20 and -80 ultralow freezers, liquid nitrogen storage tanks, electronic temperature tracking, electronic inventory control system for investigational drugs (Vestigo), pre-built oncology research order sets (EPIC Beacon) and use of the Pyxis system for narcotic and drug stock control. IDS SOPs cover transport and handling of biohazardous products, transfer of investigational product from one location to another, and preparation of all sterile compounded products and standard agents.
The investigational pharmacy manager reviews all protocols, attends SIV meetings, provides secondary checks to ensure protocol compliance, signs off on research treatment plans and participates in mock walk-throughs as necessary.
Technology/Systems
Healthcare and research software programs are harmonized and utilized across the system.
- Electronic records. We have a single instance of the electronic health record (EHR) with one standard of care across the system. Direct on-site access is granted to verify source and remote access is permitted to facilitate remote monitoring and auditing.
- Clinical trial management. All studies and research participants are entered into our central database which interfaces with our HER.
- Instant communication. Our internal care team uses a secure instant messaging platform to communicate.
- Digital signatures. A 21CFRpart11-compliant electronic signature system ensures prompt review and timely documentation of clinical trial documents.
- Virtual health. Technology eases the burden of research participation and we offer IRB-approved virtual health options for research patient visits.
Radiation Oncology
Our team helps advance important research initiatives in radiation oncology, putting us at the forefront of innovation in the field. Our state-of-the-art technology includes:
- 4D CT simulation to assess target and normal tissue movement during the respiratory cycle
- Intensity Modulated Radiation Therapy (IMRT) and Volumetric Modulated Arc Therapy (VMAT or RapidArc)
- Image-Guided Radiation Therapy (IGRT) utilizing MV imaging, KV imaging cone beam CT scanning, and Exactrac with 6D robotic motion
- 3-dimensional Conformal Radiation Therapy
- Deep Inspiration Breath Hold technique for treating left breast cancers
- Low-Dose Rate Brachytherapy for prostate cancer, head and neck cancer, soft tissue sarcoma and other tumor types
- High-Dose Rate Brachytherapy for gynecologic, breast, prostate, head and neck cancer, lung and esophageal cancers, sarcoma and other tumor types
- Systemic radioisotopes to manage bony metastatic disease and lymphoma
- Stereotactic Radiosurgery (SRS) and Stereotactic Radiation Therapy (SRT) for primary and metastatic brain tumors
- Stereotactic Body Radiation Therapy (SBRT) for lung cancer, spine lesions, liver lesions and other tumor types
- Yttrium 90 radioembolization for primary and metastatic liver tumors
- Collaboration with medical oncology colleagues to optimize personalized concomitant therapies including chemotherapy, immunotherapy and targeted molecules
Data Science
The Hartford Hospital Department of Research Administration is well-equipped with network-secured 32/64-bit computers using Windows 7 and/or Linux. Specialized database management includes SQL Management Studio, Navica and MySql WorkBench. Software for statistical analysis and data visualization includes SPSS, STATA, R, Python and TIBCO Spotfire. Databases are hosted on two network-secured virtual 2008 SQL servers, each of which contains multiple databases, and collections of securable objects. Every SQL server securable has associated permissions to be granted by the system administrator. Once approved, each user is granted a login and password to access the database. The servers are backed up daily and the architecture includes a building failure redundant cluster environment maintained offsite to ensure functionality.
We have a team of data managers experienced in data extraction from our EMR and creating sophisticated data collection tools, modeling and forecasting. They also have experience creating data feeds for IRB-approved studies.