The firm, a division of invivodata, said it has expanded its services offerings by 30 per cent to help industry players make PRO strategy decisions, offer guidance to researchers throughout the PRO data collection process, and provide assistance as they seek regulatory approval of label claims based on PRO data.
Christine Tobin of invivodata, told Outsourcing-Pharma: “Pro Consulting's services have been designed to help researchers meet their clinical development objectives and satisfy regulatory expectations.
“Because of our knowledge and experience working within the FDA’s Guidance on PROs in Clinical Research, [submitted in 2009,] we are able to customise our services or draw from our portfolio of services to meet the specific needs of our clients, whether that be developing PRO strategies, implementing PRO instruments, or going through the regulatory submission and approval process.”
PRO Consulting now offers concept and instrument evaluation and development services, data management and regulatory meeting support, and translation and linguistic validation services, in addition to guidance on scientific communications and paper to electronic migration.
Tobin said the firm's newly available services have been designed to ensure that PRO instruments used to evaluate a product’s efficacy and support its registration and labelling are “fit for purpose.”
The Pennsylvania, US-based company does this by encouraging researchers to carefully consider the concepts that are central to establishing a drug’s efficacy, and the instruments that can reliably measure those concepts. PRO Consulting then suggests researchers should think about how those instruments will be used in trials to construct the optimal endpoints to support label claims.
Tighter regulations
As the US Food and Drug Administration (FDA) gradually tighten its regulatory expectations, PRO Consulting said it has seen an increase in demand for PRO services. This demand soared in 2006 when the FDA issued its first draft guidance on PROs in clinical development.
PRO Consulting claims the pharma industry is becoming far more knowledgeable about the role and benefits of PROs and the scientific and regulatory considerations implemented in clinical development programs.
“The direction we are now headed can best be summed up as ‘Begin with the end in mind’,” said the firm, whose philosophy is to advise researchers to consider their target PRO-based labelling claims at the beginning of their program planning -a recurrent theme throughout the FDA’s guidance on PROs in clinical research.