Production of high-quality marketing applications: strategies for biotechnology companies working with contract research organizations.
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.
Hecker
Sandra J
SJ
Hecker and Associates, Arlington, VA, USA.
Preston
Christopher
C
Foote
MaryAnn
M
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