title: Production of high-quality marketing applications: strategies for biotechnology companies working with contract research organizations.
abstract: Many biotechnology and pharmaceutical companies use clinical research organizations (CROs) to assist in the writing and preparation of clinical documents intended for submission to health authorities. Start-up companies often require the expertise of a CRO to prepare their first regulatory documents. Larger or more experienced companies often require CRO staff to assist at times of multiple simultaneous submissions. The timely production of high-quality new drug marketing applications requires close collaborations between the drug company and the CRO. The views of both CRO and industry in ensuring best practices are discussed.
authors.affiliation: Hecker and Associates, Arlington, VA, USA.
authors.forename: Sandra J
authors.initials: SJ
authors.lastname: Hecker
authors.forename: Christopher
authors.initials: C
authors.lastname: Preston
authors.forename: MaryAnn
authors.initials: M
authors.lastname: Foote
mesh_terms: D001709:Biotechnology / Q000379:methods / Q000458:organization & administration* / Q000592:standards; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods* / Q000592:standards; D018795:Device Approval / Q000331:legislation & jurisprudence / Q000592:standards; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods* / Q000458:organization & administration*; D007373:Interinstitutional Relations; D040541:Marketing / Q000379:methods* / Q000458:organization & administration*; D020416:Outsourced Services / Q000379:methods* / Q000458:organization & administration*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence