ARTICLES BY KAMILA NOVAK

• Is Being Competent And Qualified The Same Thing In The GCP World?

  9/13/2023

  When it comes to Good Clinical Practice principles, the mention of "competence" is underwhelming. Yet, there is plenty of talk about education, training, and experience. Is "competent" and "qualified" synonymous? Does one imply the other? And why does it matter? Kamila Novak of KAN Consulting explores and explains.

• Study Participant Consenting — Can We Do A Better Job?

  7/24/2023

  Informed consent documents (ICDs) can be long and complicated, for consenting patients, for auditors, and, sometimes, for regulators. So what can be done to make them better? Guest expert Kamila Novak shares real-life examples of ICDs gone wrong and a few ways to make things right.

• A Firsthand Experience In Africa — Sub-Sahara Has A Lot To Offer

  12/6/2022

  In “Better Than Expected — A Firsthand Experience In Africa,” Kamila Novak shared her positive impressions from visiting medical research centers in sub-Saharan Africa. However, the picture would not be complete without talking about the continent’s personal safety and professional security, regulatory landscape, and ongoing socioeconomic challenges.

• A Firsthand Experience In Africa — Better Than Expected

  11/29/2022

  Except for South Africa, sub-Saharan African countries are still largely underrepresented in the global clinical study map. Hesitation to conduct clinical studies in Africa may be partly a result of assumed poor infrastructure, missing regulations, and inexperienced researchers. But is it truly so? Or is our thinking stuck somewhere in the past?

• Should We Pay Patients In Clinical Trials For Their Time?

  9/29/2022

  Many countries don't reimburse clinical trial patients for their time and inconvenience. Is it ethical to pay them or not? This article looks at the perspectives of some of the major regulatory authorities. Can we find common ground? What actions can we take as members of industry?

• A 4-Step Strategy For Small Sponsors To Select The Right CRO

  8/31/2022

  Selecting the right CRO to conduct our clinical study is not a difficult task, right? It's a bit more complicated than choosing a one-stop shop. You need to ask yourself questions such as: "What are our needs and requirements?", "How many providers and vendors do we want to engage?", and more.

• Should We Build Or Break Skill Silos In Clinical Trials?

  1/25/2022

  We tend to forget to talk about the knowledge and skill silos in clinical trials that we have built over the years. This article describes how the industry got to where we are with narrow specialization and recommends 5 strategies to break skill silos.

• Data Interoperability: The First Step To Leverage ML & AI In Clinical Trials

  12/9/2021

  The first hurdle we need to overcome to leverage machine learning and AI in clinical development is data interoperability. We must break data silos, find a way to make the data points communicate with one another within the drug development continuum, and analyze each data point in its full context. This article also delves into the importance of metadata and the differences between different data formats.

• Best Practices for Risk Assessment of GxP Vendors and Inspection Readiness

  9/21/2021

  Requirements for risk management in clinical trials are outlined in GCP (R2) and provide you, as the sponsor, with the main steps for risk management in your studies. The implementation will vary from vendor to vendor depending on their delegated duties and functions. In addition to that, there are three other important considerations.

• What Risk-Based Oversight Of GxP Vendors Is & Is Not In Clinical Trials

  9/2/2021

  Some pharmaceutical companies still have a notion that delegating responsibility for a clinical trial to a vendor is a way to transfer risks related to the delegated duties and functions. Nothing is further from the truth. This article examines what is vendor oversight in the context of ICH's GCP (R2) guideline.