SOLUTIONS > OBSERVATIONAL STUDIES
We have extensive expertise and experience in the design, development, and management of longitudinal biomarker-based clinical trials, prospective and retrospective observational studies, and real-world evidence studies. Unlike larger organizations, Exactis is able to offer flexible and customizable clinical research execution capabilities, and our team will support and adapt to your needs every step of the way.
WHAT WE DO
Our study start-up team will ensure that all pre-study activities are initiated promptly and efficiently including regulatory and REB submissions, investigator meetings, site initiation visits (SIVs) and vendor selection.
Our clinical data management team can develop and/or manage all your clinical data based on sponsor’s needs including paper or electronic case report form (eCRF) development, data monitoring, statistical analysis and data reporting.
An assigned Project Manager will build the optimal team for each trial while having a firm commitment to patients, clinicians and regulators.
We will communicate effectively with the study team and follow our proven SOPs for planning and execution, while executing the highest standards.
- Regulatory writing
- Protocol development
- Informed consent forms
- Regulatory and REB submissions
- Study start-up
- Site selection and qualification
- Contract & budget negotiations
- Electronic data capture system development (eCRFs)
- Study Management
- Project Management
- Data Management
- Biospecimen management
- Patient genomic pre-screening
- Data management and analysis
- Publications/abstracts for peer reviewed journals and conferences
ACCESS TO CLINICAL SAMPLE PROFILING
Our network includes five hospital laboratories in four Canadian provinces offering next-generation sequencing (NGS) analysis of both tumour tissues and blood samples, using a diversity of panels and generating rapid results, including research use only (RUO) to clinical grade (CLIA) profiling data.
This service provides sponsors, as well as clinical and basic researchers, with expedited access to potential study participants matching an inclusion criteria, including a biomarker not tested by standard of care.