Services
Trial Access and Identification
Clinically-driven trial and access to novel therapeutics begins with identifying medical conditions and areas that are most important to our providers and patient populations. If you would like to be matched with upcoming clinical trials, or have a care area of interest, please contact us.
Study Start-up and Compliance
- Provides support throughout the study start-up process, including CDA submission and negotiation, feasibility assessments, and site selection activities.
- Establish all foundational elements required for study initiation.
- Initiate study sites and finalize study protocols.
- Complete regulatory documentation and obtain ethics approvals.
- Develop detailed operational and study management plans.
- Implement staff training to ensure protocol adherence and study readiness.
- Establish quality assurance processes and monitoring procedures.
- Ensure full regulatory compliance before study launch.
- Confirm operational readiness for successful study commencement.
Patient Recruitment and Study Execution
- Engage and recruit participants through targeted outreach and recruitment activities.
- Screen potential participants to assess eligibility for study enrollment.
- Obtain informed consent and enroll eligible participants into the study.
- Conduct all study procedures and protocol-required visits according to approved study guidelines.
- Monitor participant safety throughout the study duration.
- Ensure adherence to study protocols and regulatory requirements.
- Maintain accurate and timely study documentation and data collection.
- Uphold the highest standards of participant care, safety, and research integrity.
Data Management and Study Close-out
- Collect, validate, and manage all study data throughout the study lifecycle.
- Monitor study progress and overall performance to ensure objectives are met.
- Maintain data quality, accuracy, and regulatory compliance.
- Conduct final site visits and complete study close-out procedures.
- Review and reconcile study documentation to ensure completeness and accuracy.
- Ensure all records meet regulatory, ethical, and sponsor requirements.
- Support data analysis and interpretation of study findings.
- Prepare and contribute to final reports and regulatory submissions.
- Facilitate successful closure and archiving of study records.
HR/Finance/Legal Support
- Provides integrated operational support to ensure the program is effectively staffed, financially sustainable, and compliant with organizational and regulatory requirements.
- Supports recruitment, workforce planning, budget development, financial oversight, and resource allocation to enable efficient program delivery.
- Provides guidance and administrative support for contract negotiations, amendments and submissions.
- Contributes to the long-term sustainability and growth of the program through strategic planning, governance support, and administrative expertise.
Additional Services
ACH-BioCORE please see link below or email Josee Wong- jfwong@ucalgary.ca
Please contact Dori-Ann Martin at Dori-Ann.Martin@albertahealthservices.ca to discuss additional supports that are not listed above