Many biopharma companies remain challenged to comply with mandatory government requirements for disclosing clinical trial information, whether due to lack of knowledge or lack of effective corporate policies and procedures. A strategy including documenting disclosure requirements and trials subject to disclosure, identifying internal stakeholders with compliance responsibilities, implementing policies explicitly endorsed by top management, and tapping into useful tech tools can help remedy the problem.
The stakes can be significant. With increasing scrutiny by transparency advocates and the start of inspections by health authorities, the...