
Clinical trial design and oversight.
Our clinical trial design services include pre-investigational drug application support for Phase 1 first-in-man trials, additional Phase 1 trials for special populations, thorough QT studies, Phase 2 and Phase 3 efficacy trials, and Phase 4 post-marketing studies. The design phase includes assistance with determining the population for study, eligibility criteria and safety/efficacy assessments. Trial oversight services includes day-to-day medical oversight to monitor the safety of human participants; assessment of adverse events, including serious adverse events, and the accompanying regulatory requirements for expedited safety reporting; interaction with the operational team to ensure compliance with Good Clinical Practices; review and interpretation of data; writing and editing of safety narratives and the clinical study report.
Clinical operations.
Our clinical operations services leverage a unique blend of hands-on project management and study oversight across a broad spectrum of therapeutic areas. Services include protocol development, informed consent preparation, CRF development, CRO selection and oversight, clinical site selection, management and training of project managers and clinical research associates, SOP development, data review and metrics tracking.
Research and medical consulting.
In support of your product development efforts, BioPharmAdvisors provides research into disease entities, treatments, ongoing clinical trials, regulatory requirements and history and potential market-related issues.
Business development, strategy and employee recruitment.
Together with our strategic partners from MedSurgPI, BioPharmAdvisors provides end-to-end expertise and support for your products. From medical affairs strategy, employee recruitment and business development technical support to strategies and support for publication development and startups, BioPharmAdvisors provides a single-source portal to some of the top expertise available to healthcare and life science companies.
Medical consulting for the media.
BioPharmAdvisors provides medical expertise to assist in vetting potential candidates for advertising campaigns and videos to ensure they meet the requirements for the disease and campaign.