BioBridges has been engaged by an emerging, medical device company to provide a clinical development team that will provide hands-on expertise and strategic support in the following areas; program direction and management, regulatory support, statistical support, quality assurance, medical writing, site monitoring, and medical monitoring.
BioBridges has been engaged by an established, Philadelphia-based pharmaceutical company to prepare a manuscript for publication in a toxicology journal.
BioBridges has been engaged by an emerging biotherapeutic company to perform a site-audit for a newly selected CRO and provide overall guidance in developing internal audit SOPs and general QA systems and templates.
BioBridges has been engaged by an emerging biotherapeutic company to provide overall study-start-up expertise; including vendor selection, clinical site selection, site enrollment, and feasibility studies.
BioBridges has been engaged by an emerging pharmaceutical company to oversee and contribute to the finalization of several regulatory documents, including protocols, briefing packages, a pediatric investigational plan, and an orphan drug application.
BioBridges has been engaged by a clinical-stage pharmaceutical company to work directly with health care practitioners to support the planning, development, writing, and submittal of numerous case studies and manuscripts that depict their real-world experience prescribing the company’s drug to patients.
BioBridges has been engaged by an emerging, San Diego-based biotherapeutic company to provide strategic and hands-on biostatistics support and guidance for three early clinical programs.
BioBridges has been engaged by an emerging pharmaceutical company to lead overall data management activities for a phase II clinical program; including oversight of outsourced clinical studies, EDC systems and processes, vendor management, coordination of data review, and approvals of clinical data deliverables.
BioBridges has been engaged by a Boston-based pharmaceutical company to lead overall CRO interaction, site enrollment, and project management.
BioBridges has been engaged by a clinical-stage biopharmaceutical company to guide site identification and selection for a complex oncology study.