• Do We Need An IRB/IEC Revolution?

    Are Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs) the same? And if they're not, how are they different? Kamila Novak of KAN Consulting helps define the two bodies and their roles across the globe, as well as explains how we might rethink their roles in the future.

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

    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?

    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

    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

    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?

    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

    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?

    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

    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

    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.

Kamila Novak

Kamila Novak

Kamila Novak, MSc, got her degree in molecular genetics. Since 1995, she has been involved in clinical research in various positions in pharma and CROs. Since 2010, she has been working as an independent consultant focusing on QA and QC, as a certified auditor for several ISO standards, risk management, medical writing, and training. She is a member of the Society of Quality Assurance (SQA), the World Medical Device Organisation (WMDO), the European Medical Writers’ Association (EMWA), the Drug Information Association (DIA), the Continuing Professional Development (CPD) UK, and other professional societies.