Our clinicians, epidemiologists, biostatisticians, health outcomes researchers,
and other experts collaborate with sponsors and their advisors on
all aspects of study concepts and protocols:
- Ensure designs and endpoints are appropriate to address
scientific and commercial objectives
- Develop complete protocols for sponsor review and approval
- Manage reviews of draft protocols
- Ensure protocols are consistent with sponsor SOPs
- Manage advisory boards to obtain expert input
- Conduct primary research with medical experts – via focus groups
and/or one-on-one interviews – to assess protocol feasibility
- Feasibility
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For each protocol, UBC evaluates the array of factors that affect
the successful implementation of research and specific studies.
We examine a wide range of factors the may affect the implementation
of research programs, including:
- Research site staff, medical facilities, information technology
- IRB and contracting processes
- Office schedules
- Population of interest, and niche attributes
that impact patient availability and/or
eligibility
- Protocol inclusion/exclusion criteria and
relevant impact on site interest, population volume
and investigative site setting
- Congestion and/or volume within the
site/patient community for related/competing
programs
- Site Startup & Activation
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Our operations teams focus on ensuring the efficient startup and
activation of high-quality research sites.
UBC helps streamline each program by using customized criteria to:
- Ensure efficient and timely onboarding
- Develop and implement secure and reliable information
exchange
- Significantly reduce site activation times
- Ensure and monitor delivery of products to research sites
- Study Monitoring
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UBC’s industry-leading study monitoring is driven by our team of
highly skilled Clinical Research Associates (CRAs).
Our CRAs are supported by the UBC Monitoring Academy, a rigorous
80-hour training platform that ensures the quality of our staff and
enables us to scale study operations rapidly and efficiently.
- Full site management from project startup to closeout
- Efficient study communications and coordination, including
weekly update calls and regular reports
- Recruitment strategy
- SAE reporting guidance and query management
- Hybrid management for sites with paper and electronic CRFs
- Ongoing CRA training and development on regulatory issues, ICH
GCPs, safety reporting, identification of fraud and scientific
misconduct
- Safety Monitoring
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We support clinical development programs with comprehensive safety
monitoring services, including developing and supporting Data Safety
Monitoring Boards (DSMBs).
- Case Processing
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- Spontaneous or clinical trial adverse events
- Cases from observational studies and registries
- Serious or non-serious cases
- Remote processing in the client's database or UBC's ARGUS™ database
- Experience with ARGUS™, ARISg™, AERS™, Clintrace™, BaseCon
- Complete or partial processing including: case receipt and evaluation, data entry,quality
control, coding, narrative, causality assessment, labeling, medical evaluation,follow-up requests and tracking, reporting to authorities and other stakeholders
- Legacy case entry
- Safety Writing
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- Periodic Safety Update Reports (PSURs),
addendum reports and summary bridging
reports
- Annual Safety Reports, Development Safety
Update Reports (DSURs)
- Risk Management Plans
- Quality control and consistency check of
all safety documents
- Safety sections of the CTD and the
investigator brochure
- Expert statements
- Risk or signal analysis documents
- Responses to competent authorities
- Project/Study-Driven Safety Activities
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- Endpoint adjudication processes
- Development of Risk Management Plans,
including Safety Specifications,
Pharmacovigilance Plans, as well as Risk
Minimization Action Plans (RiskMAPs) and Risk
Evaluation and Mitigation Strategies (REMS)
- Preparation of safety study specific
documentation (SAE form, safety management
plan)
- Database setup (products, reporting rules,
users) and documentation
- Process and workflow definition, SOP
preparation
- Communication with third parties (clinical
CROs) and preparation of safety data management
documents
- Registration for safety reporting to
authorities (Eudravigilance)
- Training of investigators, CRAs,
sponsor/MAH staff
- Signal detection and evaluation
- Reporting to authorities (E2B, CIOMS,
MedWatch)
- Reporting compliance monitoring
- Monthly status reports
- Ensure and monitor prescriber attestation
- Pharmacy enrollment
- Track fulfillment status
- Coordinate specialty distribution needs
- Consulting Activities
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- Literature search activities
- Training activities (investigators, CRAs,
sales representatives, general staff)
- Safety data exchange agreements
- Safety systems due diligence
- SOPs and detailed description of
pharmacovigilance system
- Safety surveillance post REMS and/or EU-RMP
implementation
- Technology Solutions
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- Safety document tracking logistics and data
management
- Project portal for document exchange and
key performance indicators monitoring
