The team is experienced with projects ranging from Phase 2 to Phase 4 clinical trials, pharmacokinetic (PK) studies, and PK sampling. The team also facilitates opportunities to conduct basic science and translational research.
Pharmaceutical Industry-sponsored Multicentric Trials | Investigator-initiated Trials | |
---|---|---|
Assist investigators in developing scientifically-vigorous study protocols/proposals | x | |
Development of Confidential Disclosure Agreements | x | |
Development of site feasibility questionnaires | x | |
Budget negotiation/contract development/management | x | x |
Submission to regulatory bodies | x (OSPARS & IRB) | x (IRB and clinicaltrials.gov) |
Site selection & initiation visits | x | |
Facilitate recruitment and enrollment of study patients | x | x |
Data collection & data entry | x | |
Monitoring visits | x | |
Study close out | x | |
Generate reports, presentations, and manuscripts | x | x |