This article is the second in a series examining strategies that allow quality groups to collaborate with GCP and GMP groups to improve ICH E6(R2) compliance, increase clinical study robustness, and enhance data integrity.
Small to midsize pharmaceutical or biotech companies (small pharma) are enjoying the best of times. However, from a quality systems perspective, it could be the worst of times. Many have weak quality systems, are not following global regulatory authority regulations and/or guidance, or lack the level of documentation required to reconstruct every aspect of clinical trials.
In his recent column, Jim Kremidas, executive director of the Association of Clinical Research Professionals, challenged the industry to address the need to raise the standards of professionalism of the clinical research workforce To say that Jim has been obsessed about helping the industry understand the impact that variance in personnel performance has on the quality conduct of clinical research and ultimately, the patient experience, would be an understatement.