ARTICLES BY KAMILA NOVAK

• How Can AI Change Computerized System Validation?

  1/27/2026

  Learn how AI technologies are changing the computer system validation (CSV) landscape and what you need to understand about this transformation.

• A Guide To Guidelines: How ICH And Others Help Us Conduct Better Trials

  7/11/2025

  Guidelines abound in clinical research. So, how should sponsor companies and partners think about their role in ensuring compliance? Consultant Kamila Novak explores their importance.

• If Sponsors Invite Patients To See The Final Draft Protocol, It's Already Too Late

  9/17/2024

  Consultant Kamila Novak dives into the importance of early patient input — and why sponsors have a hard time getting it (and implementing it).

• Going Beyond Generative AI And Templates To Create Informed Consent Documents

  6/18/2024

  Informed consent documents (ICDs) should be easy to understand. More often, they are long and complex. Consultant Kamila Novak details how to create ICDs that actually meet patients' needs.

• 2 Ways To Make Eligibility Checklists More Meaningful

  6/10/2024

  Why do ineligible participants make it into a study? Poorly designed eligibility checklist could be to blame. Consultant Kamila Novak shares two easy ways to make them more successful.

• Do We Need An IRB/IEC Revolution?

  11/10/2023

  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?

  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?