Six Steps to Successful Sample Management

Effective sample management is critical to the overall success of a clinical trial, however it is often one of the most overlooked aspects of a clinical research project. The loss of data due to damaged samples or inaccurate documentation can cause a clinical trial to be repeated, or can prevent valuable therapies or devices from ever coming to market.
However, by putting some time in up front, many of these challenges can be avoided. Below are six smart ways pharmaceutical companies can avoid these common pitfalls that plague the clinical research industry.
[Read more…]

Pharmaceutical Companies and Compliance – The Many Levels of Enforcement

Compliance and quality go hand in hand. You can’t ignore one and expect the other. Pharmaceutical companies take compliance very seriously; it would be unreasonable to question whether or not they do. However, because compliance is a broadly encompassing term that in isolation is ambiguous, a better question to ask is, “Which aspects of compliance are taken seriously by sponsors and which are not?”
[Read more…]

Clinical Trial Data Sharing: Landscape, Trends, and Risks

The Clinical Trial Data Sharing Landscape
The potential benefit of sharing clinical trial data (patient-level data and clinical documentation) has been recognized by various industry groups over the past several years, but the reality of sharing data is emerging. While several successful initiatives have launched, e.g. the Coalition Against Major Diseases (CAMD), and contributed to the cumulative trend to share data, recent industry commitments and policy decisions have propelled this effort in a significant way.
[Read more…]