PRO Consulting Expands Services

PRO Consulting (Pittsburgh), which helps clinical research teams incorporate patient-recorded outcome (PRO) strategies, has boosted its ability to assist new medical device makers throughout the clinical development process.

“We have expanded our services to meet the evolving needs of the biopharmaceutical and medical device industry, and to give them confidence in their PRO data strategies across all stages of their development efforts,” said Jean Paty, MD, chief scientist and regulatory advisor for the company, in a release.

The services added focus on concept evaluation and conceptual model development; the evaluation, selection, modification, and development of instruments; data management and statistics; regulatory meeting support; translation and linguistic validation; scientific communication; and paper-to-electronic migration.

PRO Consulting aims to help companies parse FDA’s guidelines on using PRO instruments in clinical trials.

“Given the finalization of the FDA’s guidance on PROs in clinical research, sponsors must be certain that their PRO research strategies and tactics meet regulatory expectations,” Paty said. “Our established team of scientific and regulatory experts has the skills and expertise to help sponsors optimize their PRO-based trials and meet regulatory guidelines.”