THOUGHT LEADERSHIP

The most important relationships are built on trust. Think of those relationships you value the most, of the people and entities you trust the most. In a business relationship, it is extremely important that you are confident that your chosen collaborators meet regulatory obligations and can effectively demonstrate due diligence and due care. While those practices are critical, there is another facit of trust that should be present even in professional relationships. It could be said that people don’t trust their spouse only because of a marriage certificate. Thus, when looking for a trustworthy CRO, sponsors should look beyond the checkboxes and audits. Look for a CRO that doesn’t just manage your data because it’s important to retaining your business or because it’s a regulatory requirement. Look for a CRO that cares about people because, at the end of the day, the development and delivery of new treatments is about delivering help to people. 

As part of the clinical research organization (CRO) community, providing expertise to biopharmaceutical, biotechnology, and medical device companies, PROMETRIKA is accustomed to being part of a clinical research team that includes these companies (‘sponsors’) in addition to a variety of supportive and complementary companies (‘vendors’).

In the world of clinical trials, ensuring the safety of participants and the reliability of study results is the highest priority. The structured approach to identifying and managing the risks to ensuring safety and data quality is known as Risk Management. Risk Management is not just a best practice—it is a core regulatory requirement.

Rounding is one of the first concepts we learn in math. It’s so familiar that most of us stop thinking about it entirely. But in clinical programming, where a single decimal place can determine whether a subject meets a criterion or whether two independent programs compare cleanly, rounding deserves a second look.

Clinical research is the indispensable method for determining the safety and efficacy of new treatments for human diseases and conditions. As crucial as dedicated biologists and chemists, medical professionals, clinical operations experts, data managers, and biostatisticians are to successful research, realization would be impossible without the participation of patients and their caregivers. Yet many potential participants, despite their willingness to engage in research, have faced some inhibiting barriers. For many years now, the industry has made progress in easing patient and caregiver burden through ever-advancing technologies. The advent of practical artificial intelligence (AI) tools is another step forward in making clinical research comfortable and attractive to patients.