Global biopharma regulations and guidelines require that individuals involved in conducting clinical trials be qualified by a combination of education, training, and experience. The components are straightforward to implement regarding internal employees, but not so clear when it comes to part-time consultants contracted to intermittently execute specific good clinical practice (GCP) tasks. Discover three trips for training independent consultants.
Small to midsize pharmaceutical or biotech companies (small pharma) are enjoying the best of times. Many have exciting products with fantastic preclinical and/or clinical results, great platforms for long-term company growth and licensing possibilities, outstanding medical and technical expertise, and support from intellectual/academic experts. 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.