Oncology Services
	Beardsworth offers a comprehensive array of services for oncology and oncology-related studies. Our CRAs and project teams are experienced and dedicated. It is not just our job; we are passionate about the work we do! And what better arena to display that in than an important one like oncology? We can provide all of these services to fit any size and scope of project for clients with virtual organizations. We can also provide these services a la carte, when clients require assistance in particular areas. Clinical Development Services such as: Clinical Development Planning Regulatory Strategy Consulting Pre-clinical toxicology and pharmacology review Preparation of IND filings Preparation for FDA meetings, including rehearsals Preparation of FDA briefing documents Negotiation and resolution of FDA questions Statistical consulting Study Start-up Services such as: Study design Statistical analysis plan Case Report Form design Protocol writing Study Manual design Investigator/site selection Pre-study qualification visits Regulatory document collection Investigator meetings Randomization services Clinical Monitoring Services and Site Management Services such as: Secured limited access to on-line status reports Site initiation visits Interim site visits Close-out visits Data Management Services such as: Database set-up and validation Double-Key Data entry Data review by RNs with critical care experience Query generation and resolution Database lock Biostatistical Analysis Safety Services such as: Medical monitoring Safety reporting and medical review Preparation of SAE narratives and summaries Support and coordination of DSMBs Support and coordination of endpoint review committees Support and review of tumor boards All Medical Writing services such as: Preparation of clinical study reports Preparation of all clinical and overview documents required for NDA or MAA filings Preparation of abstracts and manuscripts NDA / CTD filing Poster sessions			Oncology Overview Oncology Leadership Oncology Expertise Oncology Projects Oncology Services Patient Enrollment Investigators/Sites Case Studies
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