Robust Bioanalytical Studies Can Aid in Regulatory Submissions.

The article presents an interview with Amy Lavelle, Associate Director at Massachusetts Bioanalytical Lab, PPD Clinical Research, wherein, she discusses about the challenges of performing bioanalytical studies and how contract research organizations (CROs) can help mitigate possible regulatory submission problems. Also, talks about kind of data from bioanalytical studies that are included in regulatory filings; and the benefits of outsourcing bioanalytical studies.